Pub Date : 2025-06-01DOI: 10.1016/j.ccrj.2025.100113
Yaodong Tang PhD , Peinan Zhao PhD , Allen C. Cheng MBBS, PhD , Aaliya Ibrahim MClinEpid , Jenna Hassall MPhil , Edward Litton MBChB, PhD , Christopher R. Andersen MBBS, FCICM , Cindy Liang RN, GradCertN , Elissa M. Milford MBBS, PhD , Morgan Rose MBBS, PhD , Mark Plummer FCICM, PhD , Jing Kong RN, GradCertN , Kerry Johnson RN, GradCertN , Shailesh Bihari FCICM, PhD , Anis Chaba MBBS, MMSBR , Husna Begum PhD , Sherene Magana Cruz DipLH , Sze Ng MBBS , Tony Trapani B.Ed , Lewis Campbell MBChB, MSc Epi, FCICM , Aidan Burrell MBBS, PhD, FCICM
Objective
To assess the characteristics, treatments and outcomes of paediatric and adult intensive care unit (ICU) patients with respiratory syncytial virus (RSV) infection, and compare these with coronavirus disease (COVID-19) during the same period.
Design, setting, and participants
We conducted a multicenter, prospective, observational study using data from the short period incidence study of severe acute respiratory infection (SPRINT SARI) Australia, in 38 Australian ICUs from 1 June 2022 to 1 September 2024. Demographic, treatment, and outcome data were analysed for patients with confirmed RSV or COVID-19. The primary outcome was in-hospital mortality.
Results
Of 4693 patients were recorded in the SPRINT-SARI database, 2540 met inclusion criteria. RSV was more common in paediatric patients (410/620, 62%) than in adults (249/1920, 13%). Adult with RSV had more chronic pulmonary conditions than those with COVID-19. Paediatric patients with RSV had fewer comorbidities and less invasive mechanical ventilation (IMV) compared to those with COVID-19 (P < 0.05), but required longer duration of IMV once intubated. In-hospital mortality was similar for both adult RSV and COVID-19 (36/249, 14.5%) vs (260/1671, 15.6%), and paediatric RSV(3/410 [0.7%] vs 7/210 [3.3%] P = 0.07). Mortality in adults was associated with male sex, older age, comorbidities, and IMV. Mortality in children was associated with IMV only.
Conclusions
RSV infection can result in an attributable number of ICU admission in Australia, especially in specific populations including young children and older adults with respiratory comorbidities. Mortality in patients admitted to ICU is similar to COVID-19.
目的探讨呼吸道合胞病毒(RSV)感染的儿科和成人重症监护病房(ICU)患者的特点、治疗方法和预后,并与同期的冠状病毒病(COVID-19)进行比较。设计、环境和参与者我们进行了一项多中心、前瞻性、观察性研究,使用来自澳大利亚严重急性呼吸道感染短期发病率研究(SPRINT SARI)的数据,从2022年6月1日至2024年9月1日在38个澳大利亚icu中进行。分析确诊RSV或COVID-19患者的人口统计学、治疗和结局数据。主要终点是住院死亡率。结果在SPRINT-SARI数据库中记录的4693例患者中,2540例符合纳入标准。RSV在儿科患者(410/620,62%)中比在成人(249/1920,13%)中更常见。患有RSV的成人比患有COVID-19的成人有更多的慢性肺部疾病。与COVID-19患者相比,RSV患儿的合并症和侵入性机械通气(IMV)较少(P <;0.05),但需要较长的IMV插管时间。成人RSV和COVID-19的住院死亡率相似(36/249,14.5%)vs(260/1671, 15.6%),儿科RSV(3/410 [0.7%] vs 7/210 [3.3%] P = 0.07)。成人死亡率与男性、年龄、合并症和IMV有关。儿童死亡率仅与IMV有关。结论srsv感染可导致澳大利亚ICU住院人数的归因,特别是在特定人群中,包括患有呼吸道合并症的幼儿和老年人。ICU住院患者的死亡率与COVID-19相似。
{"title":"Respiratory syncytial virus infection in adult and paediatric patients admitted to intensive care in Australia: A nation-wide comparison with COVID-19","authors":"Yaodong Tang PhD , Peinan Zhao PhD , Allen C. Cheng MBBS, PhD , Aaliya Ibrahim MClinEpid , Jenna Hassall MPhil , Edward Litton MBChB, PhD , Christopher R. Andersen MBBS, FCICM , Cindy Liang RN, GradCertN , Elissa M. Milford MBBS, PhD , Morgan Rose MBBS, PhD , Mark Plummer FCICM, PhD , Jing Kong RN, GradCertN , Kerry Johnson RN, GradCertN , Shailesh Bihari FCICM, PhD , Anis Chaba MBBS, MMSBR , Husna Begum PhD , Sherene Magana Cruz DipLH , Sze Ng MBBS , Tony Trapani B.Ed , Lewis Campbell MBChB, MSc Epi, FCICM , Aidan Burrell MBBS, PhD, FCICM","doi":"10.1016/j.ccrj.2025.100113","DOIUrl":"10.1016/j.ccrj.2025.100113","url":null,"abstract":"<div><h3>Objective</h3><div>To assess the characteristics, treatments and outcomes of paediatric and adult intensive care unit (ICU) patients with respiratory syncytial virus (RSV) infection, and compare these with coronavirus disease (COVID-19) during the same period.</div></div><div><h3>Design, setting, and participants</h3><div>We conducted a multicenter, prospective, observational study using data from the short period incidence study of severe acute respiratory infection (SPRINT SARI) Australia, in 38 Australian ICUs from 1 June 2022 to 1 September 2024. Demographic, treatment, and outcome data were analysed for patients with confirmed RSV or COVID-19. The primary outcome was in-hospital mortality.</div></div><div><h3>Results</h3><div>Of 4693 patients were recorded in the SPRINT-SARI database, 2540 met inclusion criteria. RSV was more common in paediatric patients (410/620, 62%) than in adults (249/1920, 13%). Adult with RSV had more chronic pulmonary conditions than those with COVID-19. Paediatric patients with RSV had fewer comorbidities and less invasive mechanical ventilation (IMV) compared to those with COVID-19 (P < 0.05), but required longer duration of IMV once intubated. In-hospital mortality was similar for both adult RSV and COVID-19 (36/249, 14.5%) vs (260/1671, 15.6%), and paediatric RSV(3/410 [0.7%] vs 7/210 [3.3%] P = 0.07). Mortality in adults was associated with male sex, older age, comorbidities, and IMV. Mortality in children was associated with IMV only.</div></div><div><h3>Conclusions</h3><div>RSV infection can result in an attributable number of ICU admission in Australia, especially in specific populations including young children and older adults with respiratory comorbidities. Mortality in patients admitted to ICU is similar to COVID-19.</div></div>","PeriodicalId":49215,"journal":{"name":"Critical Care and Resuscitation","volume":"27 2","pages":"Article 100113"},"PeriodicalIF":1.4,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144491258","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-06-01DOI: 10.1016/j.ccrj.2025.100116
Jeremy Cohen FCICM, PhD , Anthony Delaney FCICM, FACEM, PhD , Andrew Udy FCICM, PhD , Christopher Andersen FCICM, PhD , Craig S. Anderson PhD , Judith Bellapart FCICM, PhD , Louise M. Burrell MBChB, MD , Anthony Devaux PhD , David M. Evans PhD , Emily Fitzgerald RN, MN , Tessa Garside FCICM, PhD , Naomi Hammond RN, PhD , Miranda Hardie BN, GradCertCritCare , Rosalind L. Jeffree M.Sc, FRACS , Serena Knowles RN, PhD , Melissa Lassig-Smith RN , Qiang Li AStat MBiostat , Gladness Nethathe FCA (SA), Cert Crit Care (SA) , Dorrilyn Rajbhandari PGDip Clin Nurs , Mahesh Ramanan FCICM, PhD , Balasubramanian Venkatesh FCICM, MD
Background and rationale
Hyponatraemia is a common complication after aneurysmal subarachnoid haemorrhage (aSAH) and is associated with worse outcomes. Fludrocortisone, a synthetic mineralocorticoid, may be an effective treatment for hyponatraemia, but its effect on clinical outcomes is unknown.
Objectives
The objective of this study was to describe the study protocol for the Fludrocortisone in Aneurysmal Subarachnoid Haemorrhage (FLASH) trial.
Design setting and participants
The FLASH trial is a phase three randomised, blinded, placebo-controlled, multicentre trial comparing 14 days of treatment with fludrocortisone to matching placebo in adult patients with acute aSAH at hospitals in Australia, New Zealand, and the United Kingdom. The planned sample size is 524 patients.
Main outcome measures
The primary outcome measure is the Modified Rankin Scale score assessed at 6 months after randomisation. The secondary outcome is the Subarachnoid Haemorrhage Outcome Tool score assessed at the same time point. Tertiary outcomes are based on international guidelines for core outcome sets and include economic and quality-of-life analyses. Prespecified subgroups for analysis will comprise aSAH severity and the presence of hyponatraemia at randomisation.
Results and conclusions
The FLASH trial aims to commence recruitment in May 2025.
{"title":"Fludrocortisone to treat patients with aneurysmal subarachnoid haemorrhage: Protocol for an international, phase 3, randomised, placebo-controlled, multicentre trial","authors":"Jeremy Cohen FCICM, PhD , Anthony Delaney FCICM, FACEM, PhD , Andrew Udy FCICM, PhD , Christopher Andersen FCICM, PhD , Craig S. Anderson PhD , Judith Bellapart FCICM, PhD , Louise M. Burrell MBChB, MD , Anthony Devaux PhD , David M. Evans PhD , Emily Fitzgerald RN, MN , Tessa Garside FCICM, PhD , Naomi Hammond RN, PhD , Miranda Hardie BN, GradCertCritCare , Rosalind L. Jeffree M.Sc, FRACS , Serena Knowles RN, PhD , Melissa Lassig-Smith RN , Qiang Li AStat MBiostat , Gladness Nethathe FCA (SA), Cert Crit Care (SA) , Dorrilyn Rajbhandari PGDip Clin Nurs , Mahesh Ramanan FCICM, PhD , Balasubramanian Venkatesh FCICM, MD","doi":"10.1016/j.ccrj.2025.100116","DOIUrl":"10.1016/j.ccrj.2025.100116","url":null,"abstract":"<div><h3>Background and rationale</h3><div>Hyponatraemia is a common complication after aneurysmal subarachnoid haemorrhage (aSAH) and is associated with worse outcomes. Fludrocortisone, a synthetic mineralocorticoid, may be an effective treatment for hyponatraemia, but its effect on clinical outcomes is unknown.</div></div><div><h3>Objectives</h3><div>The objective of this study was to describe the study protocol for the Fludrocortisone in Aneurysmal Subarachnoid Haemorrhage (FLASH) trial.</div></div><div><h3>Design setting and participants</h3><div>The FLASH trial is a phase three randomised, blinded, placebo-controlled, multicentre trial comparing 14 days of treatment with fludrocortisone to matching placebo in adult patients with acute aSAH at hospitals in Australia, New Zealand, and the United Kingdom. The planned sample size is 524 patients.</div></div><div><h3>Main outcome measures</h3><div>The primary outcome measure is the Modified Rankin Scale score assessed at 6 months after randomisation. The secondary outcome is the Subarachnoid Haemorrhage Outcome Tool score assessed at the same time point. Tertiary outcomes are based on international guidelines for core outcome sets and include economic and quality-of-life analyses. Prespecified subgroups for analysis will comprise aSAH severity and the presence of hyponatraemia at randomisation.</div></div><div><h3>Results and conclusions</h3><div>The FLASH trial aims to commence recruitment in May 2025.</div></div><div><h3>Trial registration</h3><div>NCT06409364.</div></div>","PeriodicalId":49215,"journal":{"name":"Critical Care and Resuscitation","volume":"27 2","pages":"Article 100116"},"PeriodicalIF":1.4,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144513860","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-06-01DOI: 10.1016/j.ccrj.2025.100114
Rinaldo Bellomo PhD , Jorge Salluh PhD, Antonio Paulo Nassar Jr. PhD, Elisa Estenssoro PhD, Ary Serpa Neto PhD
{"title":"Expanding the critical care collaboration between Australia, New Zealand, and Brazil: The role of journals","authors":"Rinaldo Bellomo PhD , Jorge Salluh PhD, Antonio Paulo Nassar Jr. PhD, Elisa Estenssoro PhD, Ary Serpa Neto PhD","doi":"10.1016/j.ccrj.2025.100114","DOIUrl":"10.1016/j.ccrj.2025.100114","url":null,"abstract":"","PeriodicalId":49215,"journal":{"name":"Critical Care and Resuscitation","volume":"27 2","pages":"Article 100114"},"PeriodicalIF":1.4,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144279912","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-06-01DOI: 10.1016/j.ccrj.2025.100109
Balasubramanian Venkatesh MD , Diego Ariel Rey PhD , David M. Evans PhD , Lijing Yao PhD , Simon Finfer MD , Rinaldo Bellomo PhD , Tiago Chedraoui Silva PhD , Jeremy Cohen PhD , Yu Qiu PhD , Wellington dos Reis Lucena PhD , Naomi Hammond PhD , John Myburgh PhD , Qiang Li PhD , Lucas Petri Damiani PhD , Anthony Devaux PhD , Rodrigo Octavio Deliberato PhD
Background
Small observational studies suggest the effect of corticosteroids in patients with vasodilatory shock vary depending on endotypes determined by gene expression. We sought to replicate these findings in a larger cohort from a randomised clinical trial.
Methods
In a cross-sectional substudy of the Adjunctive Glucocorticoid Therapy In Septic Shock (ADRENAL) trial, patients were classified as one of two immune endotypes using predefined gene expression signatures: immune adaptive-prevalent (IA-P) or immune innate-prevalent (IN-P). We compared the outcomes of the two endotypes using a Bayesian analysis. The primary outcome was Day-28 mortality.
Findings
Of 540 patients, 267 (49.4%) were classified as IA-P and 273 (50.6%) as IN-P. In a Bayesian analysis using noninformative priors, there was no difference in the effect of hydrocortisone on 28-day mortality (odds ratio [OR] 1.43, 95% credible intervals [CrI] 0.72–2.87) and OR 1.39, 95% CrI 0.74–2.61, between the IA-P and IN-P groups, respectively. In the subgroup of patients with more severe shock (n = 215/540, 40%), the corresponding figures for IA-P and IN-P were 1.21, 95% CrI (0.31–4.74) and OR 0.72 (95% CrI 0.30–1.67), respectively. In the subgroup of patients with pulmonary sepsis (232/540, 43%), IA-P patients treated with hydrocortisone had increased mortality (OR 5.55, 95% CrI 1.81–21.2).
Interpretation
Gene expression data from patients with septic shock reveal distinct immune endotypes. There was no evidence of a heterogeneity of treatment effect of hydrocortisone on mortality in the 2 endotypes or in the subgroup with severe shock. Patients with the IA-P endotype and pulmonary sepsis appear to be harmed by corticosteroids.
{"title":"A gene expression-based approach for the precision use of hydrocortisone in septic shock patients; a secondary analysis of the ADRENAL trial","authors":"Balasubramanian Venkatesh MD , Diego Ariel Rey PhD , David M. Evans PhD , Lijing Yao PhD , Simon Finfer MD , Rinaldo Bellomo PhD , Tiago Chedraoui Silva PhD , Jeremy Cohen PhD , Yu Qiu PhD , Wellington dos Reis Lucena PhD , Naomi Hammond PhD , John Myburgh PhD , Qiang Li PhD , Lucas Petri Damiani PhD , Anthony Devaux PhD , Rodrigo Octavio Deliberato PhD","doi":"10.1016/j.ccrj.2025.100109","DOIUrl":"10.1016/j.ccrj.2025.100109","url":null,"abstract":"<div><h3>Background</h3><div>Small observational studies suggest the effect of corticosteroids in patients with vasodilatory shock vary depending on endotypes determined by gene expression. We sought to replicate these findings in a larger cohort from a randomised clinical trial.</div></div><div><h3>Methods</h3><div>In a cross-sectional substudy of the Adjunctive Glucocorticoid Therapy In Septic Shock (ADRENAL) trial, patients were classified as one of two immune endotypes using predefined gene expression signatures: immune adaptive-prevalent (IA-P) or immune innate-prevalent (IN-P). We compared the outcomes of the two endotypes using a Bayesian analysis. The primary outcome was Day-28 mortality.</div></div><div><h3>Findings</h3><div>Of 540 patients, 267 (49.4%) were classified as IA-P and 273 (50.6%) as IN-P. In a Bayesian analysis using noninformative priors, there was no difference in the effect of hydrocortisone on 28-day mortality (odds ratio [OR] 1.43, 95% credible intervals [CrI] 0.72–2.87) and OR 1.39, 95% CrI 0.74–2.61, between the IA-P and IN-P groups, respectively. In the subgroup of patients with more severe shock (n = 215/540, 40%), the corresponding figures for IA-P and IN-P were 1.21, 95% CrI (0.31–4.74) and OR 0.72 (95% CrI 0.30–1.67), respectively. In the subgroup of patients with pulmonary sepsis (232/540, 43%), IA-P patients treated with hydrocortisone had increased mortality (OR 5.55, 95% CrI 1.81–21.2).</div></div><div><h3>Interpretation</h3><div>Gene expression data from patients with septic shock reveal distinct immune endotypes. There was no evidence of a heterogeneity of treatment effect of hydrocortisone on mortality in the 2 endotypes or in the subgroup with severe shock. Patients with the IA-P endotype and pulmonary sepsis appear to be harmed by corticosteroids.</div></div>","PeriodicalId":49215,"journal":{"name":"Critical Care and Resuscitation","volume":"27 2","pages":"Article 100109"},"PeriodicalIF":1.4,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144222120","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-06-01DOI: 10.1016/j.ccrj.2025.100111
Mark Collins FCICM , Lisa Higgins PhD , Scott McAlister PhD , Forbes McGain FCICM, PhD
{"title":"Siloed thinking: The case for integrating economic and environmental analysis in critical care","authors":"Mark Collins FCICM , Lisa Higgins PhD , Scott McAlister PhD , Forbes McGain FCICM, PhD","doi":"10.1016/j.ccrj.2025.100111","DOIUrl":"10.1016/j.ccrj.2025.100111","url":null,"abstract":"","PeriodicalId":49215,"journal":{"name":"Critical Care and Resuscitation","volume":"27 2","pages":"Article 100111"},"PeriodicalIF":1.4,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144239554","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-05-23DOI: 10.1016/j.ccrj.2025.100110
Ary Serpa Neto MD, MSc, PhD, FCICM , Paul Young PhD, FCICM
{"title":"In memory of professor Rinaldo Bellomo: A giant of intensive care medicine","authors":"Ary Serpa Neto MD, MSc, PhD, FCICM , Paul Young PhD, FCICM","doi":"10.1016/j.ccrj.2025.100110","DOIUrl":"10.1016/j.ccrj.2025.100110","url":null,"abstract":"","PeriodicalId":49215,"journal":{"name":"Critical Care and Resuscitation","volume":"27 2","pages":"Article 100110"},"PeriodicalIF":1.4,"publicationDate":"2025-05-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144124628","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-05-15DOI: 10.1016/j.ccrj.2025.100108
Ary Serpa Neto MD, MSc, PhD , Mairead McNamara BAppSc, MDietPrac , Jamie Cooper MD , Tomoko Fujii MD, PhD , Alisa Higgins PhD , Carol Hodgson PhD , Leanlove Navarra BSN , Alistair Nichol MD, PhD , Sandra Peake MD, PhD , Alvaro Rea-Neto MD, MSc, PhD , Paul Secombe BMBS(hons) MClinSc, FCICM , Emily See MD , Pam Taylor , Meredith Young MPH , Fernando G. Zampieri MD, PhD , Paul Young PhD, FCICM , Rinaldo Bellomo MD, PhD , Andrew Udy MBChB, PhD , SODa-BIC investigators
Background
Metabolic acidosis is common in critically ill patients and is associated with increased risk of organ dysfunction, need for renal replacement therapy, and death. Despite its frequency and clinical relevance, the optimal treatment approach remains uncertain. Sodium bicarbonate is often used to correct acidosis, but its risk–benefit profile in this setting is unclear.
Objective
To describe the study protocol and statistical analysis plan for the sodium bicarbonate for metabolic acidosis in the intensive care unit (SODa-BIC) trial.
Design, setting and participants
Protocol for an international, multicentre, randomised, double-blind, parallel-group, superiority adaptive clinical trial. Five hundred (n = 500) adults with metabolic acidosis and receiving a continuous infusion of a vasopressor will be randomly assigned to sodium bicarbonate or placebo in a 1:1 ratio. SODa-BIC started recruiting in April 2023. It is anticipated that recruitment will be completed in 2026.
Main outcome measures
The primary outcome will be major adverse kidney events within 30 days (MAKE30). Secondary and tertiary outcomes include 30- and 90-day mortality, receipt of renal replacement therapy, and vasopressor-free and ICU-free days at day 30. All analyses will be conducted on an intention-to-treat basis.
Results and conclusions
SODa-BIC will evaluate whether sodium bicarbonate improves clinically meaningful outcomes in critically ill patients with metabolic acidosis. The trial has the potential to inform international practice guidelines and provide robust evidence to guide the treatment of a common and severe condition in the intensive care unit.
{"title":"Protocol summary and statistical analysis plan for the sodium bicarbonate for metabolic acidosis in the intensive care unit (SODa-BIC) trial","authors":"Ary Serpa Neto MD, MSc, PhD , Mairead McNamara BAppSc, MDietPrac , Jamie Cooper MD , Tomoko Fujii MD, PhD , Alisa Higgins PhD , Carol Hodgson PhD , Leanlove Navarra BSN , Alistair Nichol MD, PhD , Sandra Peake MD, PhD , Alvaro Rea-Neto MD, MSc, PhD , Paul Secombe BMBS(hons) MClinSc, FCICM , Emily See MD , Pam Taylor , Meredith Young MPH , Fernando G. Zampieri MD, PhD , Paul Young PhD, FCICM , Rinaldo Bellomo MD, PhD , Andrew Udy MBChB, PhD , SODa-BIC investigators","doi":"10.1016/j.ccrj.2025.100108","DOIUrl":"10.1016/j.ccrj.2025.100108","url":null,"abstract":"<div><h3>Background</h3><div>Metabolic acidosis is common in critically ill patients and is associated with increased risk of organ dysfunction, need for renal replacement therapy, and death. Despite its frequency and clinical relevance, the optimal treatment approach remains uncertain. Sodium bicarbonate is often used to correct acidosis, but its risk–benefit profile in this setting is unclear.</div></div><div><h3>Objective</h3><div>To describe the study protocol and statistical analysis plan for the sodium bicarbonate for metabolic acidosis in the intensive care unit (SODa-BIC) trial.</div></div><div><h3>Design, setting and participants</h3><div>Protocol for an international, multicentre, randomised, double-blind, parallel-group, superiority adaptive clinical trial. Five hundred (n = 500) adults with metabolic acidosis and receiving a continuous infusion of a vasopressor will be randomly assigned to sodium bicarbonate or placebo in a 1:1 ratio. SODa-BIC started recruiting in April 2023. It is anticipated that recruitment will be completed in 2026.</div></div><div><h3>Main outcome measures</h3><div>The primary outcome will be major adverse kidney events within 30 days (MAKE30). Secondary and tertiary outcomes include 30- and 90-day mortality, receipt of renal replacement therapy, and vasopressor-free and ICU-free days at day 30. All analyses will be conducted on an intention-to-treat basis.</div></div><div><h3>Results and conclusions</h3><div>SODa-BIC will evaluate whether sodium bicarbonate improves clinically meaningful outcomes in critically ill patients with metabolic acidosis. The trial has the potential to inform international practice guidelines and provide robust evidence to guide the treatment of a common and severe condition in the intensive care unit.</div></div><div><h3>Registration</h3><div>Clinicaltrials.gov (NCT05697770).</div></div>","PeriodicalId":49215,"journal":{"name":"Critical Care and Resuscitation","volume":"27 2","pages":"Article 100108"},"PeriodicalIF":1.4,"publicationDate":"2025-05-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144068339","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-05-06DOI: 10.1016/j.ccrj.2025.100107
Stéphane Gaudry MD, PhD , Marouane Boubaya MD , Guillaume Louis MD , Khalil Chaïbi MD, PhD , Bruno Mégarbane MD, PhD , Julien Bohe MD, PhD , Maxime Desgrouas MD , Guillaume Gele-Decaudin MD , Adrien Joseph MD, PhD , Etienne de Montmollin MD, PhD , Christophe Camus MD, PhD , Nicolas De Prost MD, PhD , Pierre Bailly MD , Samir Jaber MD, PhD , Nicolas Chudeau MD , Alexis Lambour MD , Adrien Robine MD , Béatrice La Combe MD, PhD , Antoine Kimmoun MD, PhD , Guillaume Chevrel MD , Didier Dreyfuss MD
Background
The effect of intermittent haemodialysis (IHD) vs continuous renal replacement therapy (CRRT) on mortality and/or renal function recovery in adults with acute kidney injury (AKI) and a recognised indication for renal replacement therapy (RRT) remains controversial.
Objective
To summarise the protocol and statistical analysis plan for the ICRAKI trial.
Design, settings and participants
ICRAKI is a non-inferiority multicentre randomised controlled trial comparing IHD and CRRT. We will include 1000 patients with AKI receiving (or who have received) invasive mechanical ventilation and/or catecholamine infusion and who have at least one recognised criterion for initiating RRT.
Intervention
The study compares IHD with CRRT.
Main outcomes measures
The primary endpoint is the proportion of patients who will meet one or more criteria for a major adverse kidney event (composite of death, RRT dependence and/or more than a 25 % increase in serum creatinine from baseline value) 90 days after randomisation. Secondary endpoints are time to death; mortality at day (D)28, D60 and D90; number of patients with RRT dependency at D28, D60 and D90; number of patients with more than a 25 % increase in serum creatinine from baseline value at D28, D60 and D90; intensive care unit (ICU) and hospital length of stay; time until cessation of RRT; catecholamine-free days, ventilator-free days and RRT-free days through day 28; estimated glomerular filtration rate at hospital discharge; the number of episodes of adverse events.
Conclusion
The ICRAKI trial will inform the choice of RRT modalities in critically ill patients with severe AKI. More than 300 patients were already included.
Trial registration
ClinicalTrials.gov: NCT06032884. Date of registration, 2023-09-04.
{"title":"Study protocol and statistical plan for the ICRAKI trial: Intermittent haemodialysis versus continuous renal replacement therapy for severe acute kidney injury in critically ill patients","authors":"Stéphane Gaudry MD, PhD , Marouane Boubaya MD , Guillaume Louis MD , Khalil Chaïbi MD, PhD , Bruno Mégarbane MD, PhD , Julien Bohe MD, PhD , Maxime Desgrouas MD , Guillaume Gele-Decaudin MD , Adrien Joseph MD, PhD , Etienne de Montmollin MD, PhD , Christophe Camus MD, PhD , Nicolas De Prost MD, PhD , Pierre Bailly MD , Samir Jaber MD, PhD , Nicolas Chudeau MD , Alexis Lambour MD , Adrien Robine MD , Béatrice La Combe MD, PhD , Antoine Kimmoun MD, PhD , Guillaume Chevrel MD , Didier Dreyfuss MD","doi":"10.1016/j.ccrj.2025.100107","DOIUrl":"10.1016/j.ccrj.2025.100107","url":null,"abstract":"<div><h3>Background</h3><div>The effect of intermittent haemodialysis (IHD) <em>vs</em> continuous renal replacement therapy (CRRT) on mortality and/or renal function recovery in adults with acute kidney injury (AKI) and a recognised indication for renal replacement therapy (RRT) remains controversial.</div></div><div><h3>Objective</h3><div>To summarise the protocol and statistical analysis plan for the ICRAKI trial.</div></div><div><h3>Design, settings and participants</h3><div>ICRAKI is a non-inferiority multicentre randomised controlled trial comparing IHD and CRRT. We will include 1000 patients with AKI receiving (or who have received) invasive mechanical ventilation and/or catecholamine infusion and who have at least one recognised criterion for initiating RRT.</div></div><div><h3>Intervention</h3><div>The study compares IHD with CRRT.</div></div><div><h3>Main outcomes measures</h3><div>The primary endpoint is the proportion of patients who will meet one or more criteria for a major adverse kidney event (composite of death, RRT dependence and/or more than a 25 % increase in serum creatinine from baseline value) 90 days after randomisation. Secondary endpoints are time to death; mortality at day (D)28, D60 and D90; number of patients with RRT dependency at D28, D60 and D90; number of patients with more than a 25 % increase in serum creatinine from baseline value at D28, D60 and D90; intensive care unit (ICU) and hospital length of stay; time until cessation of RRT; catecholamine-free days, ventilator-free days and RRT-free days through day 28; estimated glomerular filtration rate at hospital discharge; the number of episodes of adverse events.</div></div><div><h3>Conclusion</h3><div>The ICRAKI trial will inform the choice of RRT modalities in critically ill patients with severe AKI. More than 300 patients were already included.</div></div><div><h3>Trial registration</h3><div>ClinicalTrials.gov: <span><span>NCT06032884</span><svg><path></path></svg></span>. Date of registration, 2023-09-04.</div></div>","PeriodicalId":49215,"journal":{"name":"Critical Care and Resuscitation","volume":"27 2","pages":"Article 100107"},"PeriodicalIF":1.4,"publicationDate":"2025-05-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143906124","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-04-17DOI: 10.1016/j.ccrj.2025.100106
Mahesh Ramanan FCICM PhD , Yogesh Apte FCICM MDS , Stacey Watts RN GradCert (Crit Care) , Thomas Holland FACEM MBBS , April Hatt RNA , Alison Craswell RN PhD , Frances Lin RN PhD , Alexis Tabah FCICM MDR , Robert S. Ware PhD , Joshua Byrnes PhD , Christopher Anstey FCICM PhD , Gerben Keijzers FACEM PhD
Objective
To determine the feasibility of conducting a definitive randomised trial to determine whether, in critically ill patients requiring intensive care unit admission, early CVC insertion compared with late CVC insertion leads to increased days-alive-and-out-of-hospital at 30 days (DAH-30) post-treatment.
Design, settings and participants
We conducted a single-centre, parallel-group, feasibility randomised controlled trial with critically ill patients receiving vasopressor infusions randomised in a 1:1 ratio to receive early CVC insertion (within 4 h) or late CVC insertion (after 12 h). All patients received vasopressor infusions via a peripheral intravenous cannula (PIVC) while awaiting CVC insertion. The primary clinical outcome was DAH-30 and the primary feasibility outcome was assessed by evaluating protocol adherence, rates of recruitment, randomisation of eligible patients, retention, follow-up and missing data.
Results
We enrolled 40 patients, 20 patients per group between January 2023 and May 2024. Protocol adherence was significantly lower in the early CVC group (55 %) compared to the late CVC group (100 %, p < 0.001). The early CVC group had a median time to CVC insertion of 3.3 h (interquartile range (IQR) 1.2–3.7 h), within the 4-h target. The early and late CVC groups had a median (IQR) of 13.5 (0.0–23.5) and 19.0 (5.0–23.0) DAH-30 respectively (P = 0.18). PIVC complications were similar between the two groups with no severe complications. There were no complications among the 18 CVCs inserted during the trial.
Conclusions
Protocol adherence in the early CVC was much lower than the late CVC. Some protocol modifications will be required to enable the conduct of a larger-scale definitive trial.
Trial Registration
ACTRN12621000721808 (Australia New Zealand Clinical Trials Registry).
{"title":"A randomised, controlled, feasibility trial comparing vasopressors infused via peripheral cannula versus central venous access for critically ill adults: The VIPCA trial","authors":"Mahesh Ramanan FCICM PhD , Yogesh Apte FCICM MDS , Stacey Watts RN GradCert (Crit Care) , Thomas Holland FACEM MBBS , April Hatt RNA , Alison Craswell RN PhD , Frances Lin RN PhD , Alexis Tabah FCICM MDR , Robert S. Ware PhD , Joshua Byrnes PhD , Christopher Anstey FCICM PhD , Gerben Keijzers FACEM PhD","doi":"10.1016/j.ccrj.2025.100106","DOIUrl":"10.1016/j.ccrj.2025.100106","url":null,"abstract":"<div><h3>Objective</h3><div>To determine the feasibility of conducting a definitive randomised trial to determine whether, in critically ill patients requiring intensive care unit admission, early CVC insertion compared with late CVC insertion leads to increased days-alive-and-out-of-hospital at 30 days (DAH-30) post-treatment.</div></div><div><h3>Design, settings and participants</h3><div>We conducted a single-centre, parallel-group, feasibility randomised controlled trial with critically ill patients receiving vasopressor infusions randomised in a 1:1 ratio to receive early CVC insertion (within 4 h) or late CVC insertion (after 12 h). All patients received vasopressor infusions via a peripheral intravenous cannula (PIVC) while awaiting CVC insertion. The primary clinical outcome was DAH-30 and the primary feasibility outcome was assessed by evaluating protocol adherence, rates of recruitment, randomisation of eligible patients, retention, follow-up and missing data.</div></div><div><h3>Results</h3><div>We enrolled 40 patients, 20 patients per group between January 2023 and May 2024. Protocol adherence was significantly lower in the early CVC group (55 %) compared to the late CVC group (100 %, p < 0.001). The early CVC group had a median time to CVC insertion of 3.3 h (interquartile range (IQR) 1.2–3.7 h), within the 4-h target. The early and late CVC groups had a median (IQR) of 13.5 (0.0–23.5) and 19.0 (5.0–23.0) DAH-30 respectively (P = 0.18). PIVC complications were similar between the two groups with no severe complications. There were no complications among the 18 CVCs inserted during the trial.</div></div><div><h3>Conclusions</h3><div>Protocol adherence in the early CVC was much lower than the late CVC. Some protocol modifications will be required to enable the conduct of a larger-scale definitive trial.</div></div><div><h3>Trial Registration</h3><div>ACTRN12621000721808 (Australia New Zealand Clinical Trials Registry).</div></div>","PeriodicalId":49215,"journal":{"name":"Critical Care and Resuscitation","volume":"27 2","pages":"Article 100106"},"PeriodicalIF":1.4,"publicationDate":"2025-04-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143838937","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-03-28DOI: 10.1016/j.ccrj.2025.100100
Luke A. Perry MBBS(Hons), BSc, Andrew Silvers FANZCA, Jayme Bennetts FRACS, Julian Smith FRACS, Lisa Q. Rong MD, MSCE, FASE, FACC, Mario Gaudino MD, PhD, MSCE, FEBCTS, FACC, FAHA, Lachlan F. Miles MBBS (Hons), PGCertCU, PhD, GChPOM, FANZCA
{"title":"Trends in pulmonary artery catheter use for cardiac surgery, 2013–2023: Analysis of Australian medicare data","authors":"Luke A. Perry MBBS(Hons), BSc, Andrew Silvers FANZCA, Jayme Bennetts FRACS, Julian Smith FRACS, Lisa Q. Rong MD, MSCE, FASE, FACC, Mario Gaudino MD, PhD, MSCE, FEBCTS, FACC, FAHA, Lachlan F. Miles MBBS (Hons), PGCertCU, PhD, GChPOM, FANZCA","doi":"10.1016/j.ccrj.2025.100100","DOIUrl":"10.1016/j.ccrj.2025.100100","url":null,"abstract":"","PeriodicalId":49215,"journal":{"name":"Critical Care and Resuscitation","volume":"27 2","pages":"Article 100100"},"PeriodicalIF":1.4,"publicationDate":"2025-03-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143714413","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}