Critical Care and Resuscitation最新文献_第7页

Ventilator-associated pneumonia: A problematic outcome for clinical trials 呼吸机相关肺炎：临床试验的问题结果

IF 2.9 4区医学 Q3 CRITICAL CARE MEDICINE

Critical Care and Resuscitation

Pub Date : 2023-12-01 DOI: 10.1016/j.ccrj.2023.10.005

Paul J. Young MBChB, PhD, Anthony Delaney MBBS, MSc, PhD, Thomas Hills MBChB, MSc, DPhil

引用次数: 0

The impact of body mass index on long-term survival after ICU admission due to COVID-19: A retrospective multicentre study 体重指数对因 COVID-19 入住 ICU 后长期生存的影响：一项回顾性多中心研究

IF 2.9 4区医学 Q3 CRITICAL CARE MEDICINE

Critical Care and Resuscitation

Pub Date : 2023-12-01 DOI: 10.1016/j.ccrj.2023.10.004

Ashwin Subramaniam MBBS MMed FRACP FCICM , Ryan Ruiyang Ling MBBS , Emma J. Ridley PhD , David V. Pilcher MBBS MRCP(UK) FRACP FCICM

Objective

The impact of obesity on long-term survival after intensive care unit (ICU) admission with severe coronavirus disease 2019 (COVID-19) is unclear. We aimed to quantify the impact of obesity on time to death up to two years in patients admitted to Australian and New Zealand ICUs.

Design

Retrospective multicentre study.

Setting

92 ICUs between 1st January 2020 through to 31st December 2020 in New Zealand and 31st March 2022 in Australia with COVID-19, reported in the Australian and New Zealand Intensive Care Society adult patient database.

Participants

All patients with documented height and weight to estimate the body mass index (BMI) were included. Obesity was classified patients according to the World Health Organization recommendations.

Interventions and main outcome measures

The primary outcome was survival time up to two years after ICU admission. The effect of obesity on time to death was assessed using a Cox proportional hazards model. Confounders were acute illness severity, sex, frailty, hospital type and jurisdiction for all patients.

Results

We examined 2,931 patients; the median BMI was 30.2 (IQR 25.6–36.0) kg/m². Patients with a BMI ≥30 kg/m² were younger (median [IQR] age 57.7 [46.2–69.0] vs. 63.0 [50.0–73.6]; p < 0.001) than those with a BMI <30 kg/m². Most patients (76.6%; 2,244/2,931) were discharged alive after ICU admission. The mortality at two years was highest for BMI categories <18.5 kg/m² (35.4%) and 18.5–24.9 kg/m² (31.1%), while lowest for BMI ≥40 kg/m² (14.5%). After adjusting for confounders and with BMI 18.5–24.9 kg/m² category as a reference, only the BMI ≥40 kg/m² category patients had improved survival up to 2 years (hazard ratio = 0.51; 95%CI: 0.34–0.76).

Conclusions

The obesity paradox appears to exist beyond hospital discharge in critically ill patients with COVID-19 admitted in Australian and New Zealand ICUs. A BMI ≥40 kg/m² was associated with a higher survival time of up to two years.

目的2019年严重冠状病毒病（COVID-19）患者入住重症监护病房（ICU）后，肥胖对长期存活率的影响尚不清楚。我们旨在量化澳大利亚和新西兰重症监护病房收治的患者中，肥胖对其两年内死亡时间的影响。根据世界卫生组织的建议对肥胖患者进行分类。干预措施和主要结果测量主要结果为入住重症监护病房后两年内的存活时间。肥胖对死亡时间的影响采用Cox比例危险模型进行评估。所有患者的混杂因素包括急性病严重程度、性别、虚弱程度、医院类型和辖区。结果我们对2931名患者进行了检查；BMI中位数为30.2（IQR 25.6-36.0）kg/m2。与体重指数为 30 kg/m2 的患者相比，体重指数≥30 kg/m2 的患者更年轻（中位[IQR]年龄为 57.7 [46.2-69.0] vs. 63.0 [50.0-73.6]; p <0.001）。大多数患者（76.6%；2,244/2,931 例）在入住重症监护室后都活着出院。体重指数为 18.5 kg/m2 （35.4%）和 18.5-24.9 kg/m2 （31.1%）的患者两年后的死亡率最高，而体重指数≥40 kg/m2 的患者死亡率最低（14.5%）。结论在澳大利亚和新西兰重症监护病房收治的 COVID-19 重症患者中，肥胖悖论似乎在出院后仍然存在。体重指数≥40 kg/m2与较高的存活时间（长达两年）相关。

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引用次数: 0

Cerebrospinal fluid and plasma ascorbate concentrations following subarachnoid haemorrhage 蛛网膜下腔出血后脑脊液和血浆中的抗坏血酸浓度

IF 2.9 4区医学 Q3 CRITICAL CARE MEDICINE

Critical Care and Resuscitation

Pub Date : 2023-12-01 DOI: 10.1016/j.ccrj.2023.10.003

Natasha Turner , Brodie Farrow , Ashenafi H. Betrie , Mark E. Finnis , Yugeesh R. Lankadeva , Jeremy Sharman , Patrick Tan , Yasmine Ali Abdelhamid , Adam M. Deane , Mark P. Plummer

Background

Ascorbate, the biologically active form of vitamin C, is the primary neural anti-oxidant. Ascorbate concentrations have never been quantified following aneurysmal subarachnoid haemorrhage (aSAH).

Objective

To quantify plasma and cerebrospinal fluid (CSF) ascorbate concentrations in patients following SAH.

Design, Setting, Participants, Main Outcome Measures

Cohort study in which plasma and CSF ascorbate concentrations were measured longitudinally in 12 aSAH patients admitted to a quaternary referral intensive care unit and compared to one-off samples obtained from 20 pregnant women prior to delivery in a co-located obstetric hospital. Data are median [interquartile range] or median (95 % confidence intervals).

Results

Forty-eight plasma samples were obtained from the 12 aSAH patients (eight females, age 62 [53–68] years). Eight participants with extra-ventricular drains provided 31 paired CSF-plasma samples. Single plasma and CSF samples were obtained from 20 pregnant women (age 35 [31–37] years). Initial plasma and CSF ascorbate concentrations post aSAH were less than half those in pregnant controls (plasma: aSAH: 31 [25–39] μmol/L vs. comparator: 64 [59–77] μmol/L; P < 0.001 and CSF: 116 [80–142] μmol/L vs. 252 [240–288] μmol/L; P < 0.001). Post aSAH there was a gradual reduction in the CSF:plasma ascorbate ratio from ∼4:1 to ∼1:1. Six (50 %) patients developed vasospasm and CSF ascorbate concentrations were lower in these patients (vasospasm: 61 (25, 97) vs. no vasospasm: 110 (96, 125) μmol/L; P = 0.01).

Conclusion

Post aSAH there is a marked reduction in CSF ascorbate concentration that is most prominent in those who develop vasospasm.

背景抗坏血酸是维生素 C 的生物活性形式，是主要的神经抗氧化剂。目标定量检测动脉瘤性蛛网膜下腔出血（SAH）后患者血浆和脑脊液（CSF）中的抗坏血酸浓度。设计、地点、参与者、主要结果测量队列研究对一家四级转诊重症监护病房收治的 12 名 SAH 患者的血浆和脑脊液抗坏血酸浓度进行了纵向测量，并与在同一家产科医院分娩前从 20 名孕妇处获得的一次性样本进行了比较。数据为中位数[四分位数间距]或中位数（95 % 置信区间）。结果从 12 名 aSAH 患者（8 名女性，年龄 62 [53-68] 岁）中获得了 48 份血浆样本。8名接受室外引流的患者提供了31份配对的CSF-血浆样本。20 名孕妇（年龄 35 [31-37] 岁）提供了单份血浆和 CSF 样本。aSAH后的初始血浆和脑脊液抗坏血酸浓度低于妊娠对照组的一半（血浆：aSAH：31 [25-39] μmol/L vs. 对照组：64 [59-77] μmol/L；P <；0.001；脑脊液：116 [80-142] μmol/L vs. 252 [240-288] μmol/L；P <；0.001）。脑缺血后，脑脊液与血浆的抗坏血酸比值从 4:1 逐步降至 1:1。六名（50%）患者出现血管痉挛，这些患者的 CSF 抗坏血酸浓度较低（血管痉挛：61 (25, 97) vs. 无血管痉挛：110 (96, 125) μmol/L；P = 0.01）。

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引用次数: 0

Protocol summary and statistical analysis plan for the low oxygen intervention for cardiac arrest injury limitation (LOGICAL) trial 低氧介入治疗心脏骤停损伤限制(LOGICAL)试验的方案总结和统计分析计划

IF 2.9 4区医学 Q3 CRITICAL CARE MEDICINE

Critical Care and Resuscitation

Pub Date : 2023-09-01 DOI: 10.1016/j.ccrj.2023.06.007

Paul J. Young MBChB, PhD , Carol L. Hodgson PT, MPhil, PhD , Diane Mackle MN, PhD , Anne M. Mather BBiomed (Hons) , Richard Beasley MBChB, DSc , Rinaldo Bellomo MD , Stephen Bernard MD , Kathy Brickell RGN , Adam M. Deane PhD , Glenn Eastwood PhD , Simon Finfer MD , Alisa M. Higgins MPH, PhD , Anna Hunt BN , Cassie Lawrence BN , Natalie J. Linke BN , Edward Litton MD, PhD , Christine F. McDonald MBBS (Hons), PhD , James Moore MBChB, MSc , Alistair D. Nichol PhD , Shaanti Olatunji MClinImm , Jessica Kasza PhD

Background

The effect of conservative vs. liberal oxygen therapy on outcomes of intensive care unit (ICU) patients with hypoxic ischaemic encephalopathy (HIE) is uncertain and will be evaluated in the Low Oxygen Intervention for Cardiac Arrest injury Limitation (LOGICAL) trial.

Objective

The objective of this study was to summarise the protocol and statistical analysis plans for the LOGICAL trial.

Design, setting, and participants

LOGICAL is a randomised clinical trial in adults in the ICU who are comatose with suspected HIE (i.e., those who have not obeyed commands following return of spontaneous circulation after a cardiac arrest where there is clinical concern about possible brain damage). The LOGICAL trial will include 1400 participants and is being conducted as a substudy of the Mega Randomised registry trial comparing conservative vs. liberal oxygenation targets in adults receiving unplanned invasive mechanical ventilation in the ICU (Mega-ROX).

Main outcome measures

The primary outcome is survival with favourable neurological function at 180 days after randomisation as measured with the Extended Glasgow Outcome Scale (GOS-E). A favourable neurological outcome will be defined as a GOS-E score of lower moderate disability or better (i.e. a GOS-E score of 5–8). Secondary outcomes include survival time, day 180 mortality, duration of invasive mechanical ventilation, ICU length of stay, hospital length of stay, the proportion of patients discharged home, quality of life assessed at day 180 using the EQ-5D-5L, and cognitive function assessed at day 180 using the Montreal Cognitive Assessment (MoCA-blind).

Conclusions

The LOGICAL trial will provide reliable data on the impact of conservative vs. liberal oxygen therapy in ICU patients with suspected HIE following resuscitation from a cardiac arrest. Prepublication of the LOGICAL protocol and statistical analysis plan prior to trial conclusion will reduce the potential for outcome-reporting or analysis bias.

Trial registration

Australian and New Zealand Clinical Trials Registry (ACTRN12621000518864).

背景:保守氧疗与自由氧疗对重症监护病房(ICU)缺氧缺血性脑病(HIE)患者预后的影响尚不确定，将在低氧干预心脏骤停损伤限制(LOGICAL)试验中进行评估。目的总结logic试验的方案和统计分析方案。设计、环境和参与者:logic是一项随机临床试验，对象为ICU中疑似HIE的昏迷成人(即，在心脏骤停后恢复自发循环后不服从命令的患者，临床担心可能出现脑损伤)。logic试验将包括1400名参与者，作为Mega随机注册试验的一项子研究，比较在ICU接受无计划有创机械通气(Mega- rox)的成人中保守和自由氧合目标。主要结局指标主要结局指标是随机分组后180天具有良好神经功能的生存，用扩展格拉斯哥结局量表(GOS-E)测量。良好的神经预后将被定义为GOS-E评分为较低的中度残疾或更高(即GOS-E评分为5-8)。次要结局包括生存时间、180天死亡率、有创机械通气持续时间、ICU住院时间、住院时间、出院回家的患者比例、180天使用EQ-5D-5L评估的生活质量，以及180天使用蒙特利尔认知评估(moca盲法)评估的认知功能。结论:logic试验将为ICU患者心脏骤停复苏后疑似HIE患者保守氧疗与自由氧疗的影响提供可靠数据。在试验结论之前预先发表逻辑方案和统计分析计划将减少结果报告或分析偏倚的可能性。试验注册澳大利亚和新西兰临床试验注册中心(ACTRN12621000518864)。

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引用次数: 1

Erratum for previously published articles 以前发表的文章的勘误

IF 2.9 4区医学 Q3 CRITICAL CARE MEDICINE

Critical Care and Resuscitation

Pub Date : 2023-09-01 DOI: 10.1016/j.ccrj.2023.09.001

引用次数: 0

Study protocol for TARGET protein: The effect of augmented administration of enteral protein to critically ill adults on clinical outcomes: A cluster randomised, cross-sectional, double cross-over, clinical trial 靶蛋白的研究方案:对危重成人增加肠内蛋白给药对临床结果的影响:一项聚类随机、横断面、双交叉的临床试验

IF 2.9 4区医学 Q3 CRITICAL CARE MEDICINE

Critical Care and Resuscitation

Pub Date : 2023-09-01 DOI: 10.1016/j.ccrj.2023.08.001

Matthew J. Summers MDiet , Lee-anne S. Chapple MNutDiet, PhD , Rinaldo Bellomo MBBS, MD , Marianne J. Chapman MBBS, PhD , Suzie Ferrie MND, PhD , Mark E. Finnis MBBS, MBiostat , Craig French MBBS , Sally Hurford Post Grad Dip Clinical Research , Nima Kakho MBBS , Amalia Karahalios PhD , Matthew J. Maiden MBBS, PhD , Stephanie N. O'Connor RN, MNSc , Sandra L. Peake MBBS, PhD , Jeffrey J. Presneill MBBS, PhD , Emma J. Ridley BNutDiet, PhD , An Tran-Duy PhD , Patricia J. Williams RGN, BNP , Paul J. Young MBChB, PhD , Sophie Zaloumis PhD , Adam M. Deane MBBS, PhD

Background

It is unknown whether increasing dietary protein to 1.2–2.0 g/kg/day as recommended in international guidelines compared to current practice improves outcomes in intensive care unit (ICU) patients. The TARGET Protein trial will evaluate this.

Objective

To describe the study protocol for the TARGET Protein trial.

Design, setting, and participants

TARGET Protein is a cluster randomised, cross-sectional, double cross-over, pragmatic clinical trial undertaken in eight ICUs in Australia and New Zealand. Each ICU will be randomised to use one of two trial enteral formulae for three months before crossing over to the other formula, which is then repeated, with enrolment continuing at each ICU for 12 months. All patients aged ≥16 years in their index ICU admission commencing enteral nutrition will be eligible for inclusion. Eligible patients will receive the trial enteral formula to which their ICU is allocated. The two trial enteral formulae are isocaloric with a difference in protein dose: intervention 100g/1000 ml and comparator 63g/1000 ml. Staggered recruitment commenced in May 2022.

Main outcomes measures

The primary outcome is days free of the index hospital and alive at day 90. Secondary outcomes include days free of the index hospital at day 90 in survivors, alive at day 90, duration of invasive ventilation, ICU and hospital length of stay, incidence of tracheostomy insertion, renal replacement therapy, and discharge destination.

Conclusion

TARGET Protein aims to determine whether augmented enteral protein delivery reduces days free of the index hospital and alive at day 90.

Trial registration

Australian New Zealand Clinical Trials Registry (ACTRN12621001484831).

背景与目前的做法相比，将国际指南中建议的膳食蛋白质增加到1.2–2.0 g/kg/天是否能改善重症监护室（ICU）患者的预后尚不清楚。TARGET蛋白质试验将对此进行评估。目的描述TARGET蛋白试验的研究方案。设计、设置和参与者TARGET Protein是一项在澳大利亚和新西兰的八个重症监护室进行的集群随机、横断面、双交叉、务实的临床试验。每个ICU将被随机分配使用两种试验性肠内配方奶粉中的一种，为期三个月，然后转入另一种配方奶粉，然后重复使用，每个ICU的入组持续12个月。所有年龄≥16岁的患者在其指数ICU入院时开始肠内营养将有资格入选。符合条件的患者将获得分配给其ICU的试验肠内配方奶粉。两种试验肠内配方奶粉是等热量的，蛋白质剂量不同：干预100g/1000ml和对照63g/1000ml。交错招募于2022年5月开始。主要结果测量主要结果是无指数医院天数和90天存活天数。次要结果包括第90天幸存者无指数住院天数、第90天存活天数、有创通气持续时间、ICU和住院时间、气管造口术插入的发生率、肾脏替代治疗和出院目的地。结论TARGET蛋白旨在确定增强肠内蛋白递送是否减少了出院天数和第90天的存活时间。试验注册澳大利亚-新西兰临床试验注册中心（ACTRN12621001484831）。

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引用次数: 0

Current management of fluid balance in critically ill patients with acute kidney injury: A scoping review 急性肾损伤危重患者液体平衡的管理现状：范围界定综述

IF 2.9 4区医学 Q3 CRITICAL CARE MEDICINE

Critical Care and Resuscitation

Pub Date : 2023-09-01 DOI: 10.1016/j.ccrj.2023.06.002

Kyle C. White MBBS, MPH, FRACP, FCICM , Ahmad Nasser MBChB, Dip. Child Health, M. Paed, FCICM , Michelle L. Gatton PhD , Kevin B. Laupland MD, PhD

Objective

The overall objective of this scoping review is to assess the extent of the literature related to the fluid management of critically ill patients with acute kidney injury (AKI).

Introduction

AKI is common in critically ill patients where fluid therapy is a mainstay of treatment. An association between fluid balance (FB) and adverse patient-centred outcomes in critically ill patients with AKI regardless of severity has been demonstrated. The evidence for the prospective intervention of FB and its impact on outcomes is unknown.

Inclusion criteria

All studies investigating FB in patients with AKI admitted to an intensive care unit were included. Literature not related to FB in the critically ill patient with AKI population was excluded.

Methods

We searched MEDLINE, EMBASE, and CINAHL from January 1st, 2012, onwards. We included primary research studies, experimental and observational, recruiting adult participants admitted to an intensive care unit who had an AKI. We extracted data on study and patient characteristics, as well as FB, renal-based outcomes, and patient-centred outcomes. Two reviewers independently screened citations for eligible studies and performed data extraction.

Results

Of the 13,767 studies reviewed, 22 met the inclusion criteria. Two studies examined manipulation of fluid input, 18 studies assessed enhancing fluid removal, and two studies applied a restrictive fluid protocol. Sixteen studies examined patients receiving renal replacement therapy, five studies included non–renal replacement therapy patients, and one study included both. Current evidence is broad with varied approaches to managing fluid input and fluid removal. The studies did not demonstrate a consensus approach for any aspect of the fluid management of critically ill patients. There was a limited application of a restrictive fluid protocol with no conclusions possible.

Conclusions

The current body of evidence for the management of FB in critically ill patients with AKI is limited in nature. The current quality of evidence is unable to guide current clinical practice. The key outcome of this review is to highlight areas for future research.

目的:本综述的总体目的是评估与急性肾损伤(AKI)危重患者的液体管理相关的文献的范围。aki在重症患者中很常见，其中液体疗法是主要的治疗方法。已经证明，无论严重程度如何，急性肾损伤危重患者的体液平衡(FB)与以患者为中心的不良结局之间存在关联。FB的前瞻性干预及其对预后影响的证据尚不清楚。纳入标准:所有调查入住重症监护病房的AKI患者FB的研究均被纳入。排除AKI危重患者人群中与FB无关的文献。方法自2012年1月1日起检索MEDLINE、EMBASE和CINAHL。我们纳入了初步研究、实验和观察性研究，招募了入住重症监护病房的患有AKI的成年受试者。我们提取了研究和患者特征的数据，以及FB、基于肾脏的结果和以患者为中心的结果。两名审稿人独立筛选符合条件的研究的引用并进行数据提取。结果在13767项研究中，22项符合纳入标准。两项研究检查了液体输入的操作，18项研究评估了增强液体去除，两项研究应用了限制性液体方案。16项研究调查了接受肾脏替代治疗的患者，5项研究调查了未接受肾脏替代治疗的患者，还有一项研究同时调查了接受肾脏替代治疗的患者。目前的证据是广泛的各种方法来管理流体输入和流体排出。这些研究没有在危重病人的液体管理的任何方面证明一个共识的方法。限制性流体方案的应用有限，无法得出结论。结论目前关于急性肾损伤危重患者FB治疗的证据有限。目前的证据质量无法指导当前的临床实践。本综述的主要结果是突出了未来研究的领域。

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引用次数: 0

Improving the management of medical emergency team calls due to suspected infections: A before–after study 改进因疑似感染而拨打医疗急救电话的管理：一项前后研究

IF 2.9 4区医学 Q3 CRITICAL CARE MEDICINE

Critical Care and Resuscitation

Pub Date : 2023-09-01 DOI: 10.1016/j.ccrj.2023.06.004

Jeroen Ludikhuize MD, PhD , David Marshall MD , Misha Devchand MD, PhD , Steven Walker MD, PhD , Andrew Talman MD , Carmel Taylor RN , Tammie McIntyre RN , Jason Trubiano MD, PhD , Daryl Jones MD, PhD

Objective

To introduce a management guideline for sepsis-related MET calls to increase lactate and blood culture acquisition, as well as prescription of appropriate antibiotics.

Design

Prospective before (Jun–Aug 2018) and after (Oct–Dec 2018) study was designed.

Setting

A public university linked hospital in Melbourne, Australia.

Participants

Adult patients with MET calls related to sepsis/infection were included.

Main outcome measures

The primary outcome measure was the proportion of MET calls during which both a blood culture and lactate level were ordered. Secondary outcomes included the frequency with which new antimicrobials were commenced by the MET, and the presence and class of administered antimicrobials.

Results

There were 985 and 955 MET calls in the baseline and after periods, respectively. Patient features, MET triggers, limitations of treatment and disposition after the MET call were similar in both groups. Compliance with the acquisition of lactates (p = 0.101), respectively. There was a slight reduction in compliance with lactate acquisition in the after period (97% vs 99%; p = 0.06). In contrast, there was a significant increase in acquisition of blood cultures in the after period (69% vs 78%; p = 0.035).

Conclusions

Introducing a sepsis management guideline and enhanced linkage with an AMS program increased blood culture acquisition and decreased broad spectrum antimicrobial use but didn't change in-hospital mortality.

目的介绍脓毒症相关的MET呼叫管理指南，以增加乳酸和血培养的采集，以及适当的抗生素处方。设计了2018年6 - 8月前和2018年10 - 12月后的前瞻性研究。澳大利亚墨尔本一所公立大学附属医院。参与者包括与败血症/感染相关的MET呼叫的成年患者。主要结果测量主要结果测量是MET呼叫的比例，在此期间，血液培养和乳酸水平都被要求。次要结果包括MET开始使用新抗菌素的频率，以及使用的抗菌素的存在和类别。结果基线期和随访期分别有985次和955次MET呼叫。两组患者的特征、MET触发因素、治疗限制和MET呼叫后的处置相似。获得乳酸盐的依从性(p = 0.101)。在治疗后的一段时间内，乳酸获取的依从性略有下降(97% vs 99%;P = 0.06)。相比之下，在之后的一段时间内，获得血培养的人数显著增加(69%对78%;P = 0.035)。引入败血症管理指南并加强与AMS项目的联系，增加了血培养量，减少了广谱抗菌药物的使用，但没有改变院内死亡率。

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引用次数: 0

Potential metrics for rapid response systems in Australia and New Zealand 澳大利亚和新西兰快速反应系统的潜在指标

IF 2.9 4区医学 Q3 CRITICAL CARE MEDICINE

Critical Care and Resuscitation

Pub Date : 2023-09-01 DOI: 10.1016/j.ccrj.2023.06.006

Daryl Jones , Judit Orosz , Alex Psirides , David Pilcher

引用次数: 0

Blend to Limit OxygEN in ECMO: A RanDomised ControllEd Registry (BLENDER) Trial: Study Protocol and Statistical Analysis Plan 混合以限制ECMO中的OxygEN：随机对照注册（BLENDER）试验：研究方案和统计分析计划

IF 2.9 4区医学 Q3 CRITICAL CARE MEDICINE

Critical Care and Resuscitation

Pub Date : 2023-09-01 DOI: 10.1016/j.ccrj.2023.06.001

Aidan Burrell PhD , Sze Ng MBBS , Kelly Ottosen MHealthSc , Michael Bailey PhD , Hergen Buscher MD , John Fraser PhD , Andrew Udy PhD , David Gattas MMed(ClinEpi) , Richard Totaro MBBS , Rinaldo Bellomo PhD , Paul Forrest MBChB , Emma Martin BpharmSc , Liadain Reid MPH , Marc Ziegenfuss MBBS , Glenn Eastwood PhD , Alisa Higgins PhD , Carol Hodgson PhD , Edward Litton PhD , Priya Nair PhD , Neil Orford PhD , David Pilcher MBBS

Introduction

Critically ill patients supported with venoarterial extracorporeal membrane oxygenation (VA ECMO) are at risk of developing severe arterial hyperoxia, which has been associated with increased mortality. Lower saturation targets in this population may lead to deleterious episodes of severe hypoxia. This manuscript describes the protocol and statistical analysis plan for the Blend to Limit OxygEN in ECMO: A RanDomised ControllEd Registry (BLENDER) Trial.

Design

The BLENDER trial is a pragmatic, multicentre, registry-embedded, randomised clinical trial., registered at ClinicalTrials.gov (NCT03841084) and approved by The Alfred Hospital Ethics Committee project ID HREC/50486/Alfred-2019.

Participants and setting

Patients supported by VA ECMO for cardiogenic shock or cardiac arrest who are enrolled in the Australian national ECMO registry.

Intervention

The study compares a conservative oxygenation strategy (target arterial saturations 92–96%) with a liberal oxygenation strategy (target 97–100%).

Main Outcome Measures

The primary outcome is the number of intensive care unit (ICU)-free days for patients alive at day 60. Secondary outcomes include duration of mechanical ventilation, ICU and hospital mortality, the number of hypoxic episodes, neurocognitive outcomes, and health economic analyses. The 300-patient sample size enables us to detect a 3-day difference in ICU-free days at day 60, assuming a mean ICU-free days of 11 days, with a risk of type 1 error of 5% and power of 80%. Data will be analysed according to a predefined analysis plan. Findings will be disseminated in peer-reviewed publications.

Conclusions

This paper details the protocol and statistical analysis plan for the BLENDER trial, a registry-embedded, multicentre interventional trial comparing liberal and conservative oxygenation strategies in VA ECMO.

引言采用体外膜肺氧合（VA ECMO）支持的危重患者有发展为严重动脉高氧的风险，这与死亡率增加有关。该人群中较低的饱和靶点可能导致严重缺氧的有害发作。这篇手稿描述了ECMO中混合限制OxygEN的方案和统计分析计划：随机对照注册（BLENDER）试验。设计BLENDER试验是一项实用、多中心、注册嵌入的随机临床试验。，注册于ClinicalTrials.gov（NCT03841084），并经阿尔弗雷德医院伦理委员会项目ID HREC/50486/Alfred-2019批准。参与者和设置在澳大利亚国家ECMO注册中心注册的VA ECMO支持的心源性休克或心脏骤停患者。干预该研究比较了保守的氧合策略（目标动脉饱和度92–96%）和自由的氧合战略（目标97–100%）。主要结果测量主要结果是患者在第60天无重症监护室（ICU）的天数。次要结果包括机械通气持续时间、ICU和医院死亡率、缺氧发作次数、神经认知结果和健康经济分析。300名患者的样本量使我们能够在第60天检测到无ICU天数的3天差异，假设平均无ICU天数为11天，1型错误的风险为5%，幂为80%。数据将根据预定义的分析计划进行分析。调查结果将在同行评审的出版物中散发。结论本文详细介绍了BLENDER试验的方案和统计分析计划，这是一项注册嵌入式多中心介入试验，比较了VA ECMO中自由和保守的氧合策略。

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引用次数: 0