Critical Care and Resuscitation最新文献

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).

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).

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.

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.

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.

The use of mRNA COVID-19 vaccine can on rare occasions cause life-threatening, fulminant myopericarditis. This case report demonstrates previously reported benefit of early use of venoarterial extracorporeal membrane oxygenation mechanical assistance and supports the use of intravenous highly purified immunoglobulin pharmacotherapy to help achieve a good clinical outcome.