Critical Care and Resuscitation最新文献

{"title":"Ventilator-associated pneumonia: A problematic outcome for clinical trials","authors":"Paul J. Young MBChB, PhD, Anthony Delaney MBBS, MSc, PhD, Thomas Hills MBChB, MSc, DPhil","doi":"10.1016/j.ccrj.2023.10.005","DOIUrl":"https://doi.org/10.1016/j.ccrj.2023.10.005","url":null,"abstract":"","PeriodicalId":49215,"journal":{"name":"Critical Care and Resuscitation","volume":"25 4","pages":"Pages 159-160"},"PeriodicalIF":2.9,"publicationDate":"2023-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S1441277223022160/pdfft?md5=0c38d05fa614a2c658eb90445f4c01a5&pid=1-s2.0-S1441277223022160-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139038537","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}

{"title":"The impact of body mass index on long-term survival after ICU admission due to COVID-19: A retrospective multicentre study","authors":"Ashwin Subramaniam MBBS MMed FRACP FCICM ,&nbsp;Ryan Ruiyang Ling MBBS ,&nbsp;Emma J. Ridley PhD ,&nbsp;David V. Pilcher MBBS MRCP(UK) FRACP FCICM","doi":"10.1016/j.ccrj.2023.10.004","DOIUrl":"https://doi.org/10.1016/j.ccrj.2023.10.004","url":null,"abstract":"<div><h3>Objective</h3><p>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.</p></div><div><h3>Design</h3><p>Retrospective multicentre study.</p></div><div><h3>Setting</h3><p>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.</p></div><div><h3>Participants</h3><p>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.</p></div><div><h3>Interventions and main outcome measures</h3><p>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.</p></div><div><h3>Results</h3><p>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 &lt; 0.001) than those with a BMI &lt;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 &lt;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).</p></div><div><h3>Conclusions</h3><p>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.</p></div>","PeriodicalId":49215,"journal":{"name":"Critical Care and Resuscitation","volume":"25 4","pages":"Pages 182-192"},"PeriodicalIF":2.9,"publicationDate":"2023-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S1441277223022159/pdfft?md5=f51bc221c020ffbf242635da08c6c270&pid=1-s2.0-S1441277223022159-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139038541","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}

{"title":"Cerebrospinal fluid and plasma ascorbate concentrations following subarachnoid haemorrhage","authors":"Natasha Turner ,&nbsp;Brodie Farrow ,&nbsp;Ashenafi H. Betrie ,&nbsp;Mark E. Finnis ,&nbsp;Yugeesh R. Lankadeva ,&nbsp;Jeremy Sharman ,&nbsp;Patrick Tan ,&nbsp;Yasmine Ali Abdelhamid ,&nbsp;Adam M. Deane ,&nbsp;Mark P. Plummer","doi":"10.1016/j.ccrj.2023.10.003","DOIUrl":"https://doi.org/10.1016/j.ccrj.2023.10.003","url":null,"abstract":"<div><h3>Background</h3><p>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).</p></div><div><h3>Objective</h3><p>To quantify plasma and cerebrospinal fluid (CSF) ascorbate concentrations in patients following SAH.</p></div><div><h3>Design, Setting, Participants, Main Outcome Measures</h3><p>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).</p></div><div><h3>Results</h3><p>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 &lt; 0.001 and CSF: 116 [80–142] μmol/L vs. 252 [240–288] μmol/L; P &lt; 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).</p></div><div><h3>Conclusion</h3><p>Post aSAH there is a marked reduction in CSF ascorbate concentration that is most prominent in those who develop vasospasm.</p></div>","PeriodicalId":49215,"journal":{"name":"Critical Care and Resuscitation","volume":"25 4","pages":"Pages 175-181"},"PeriodicalIF":2.9,"publicationDate":"2023-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S1441277223005185/pdfft?md5=34bd2c887703c2d13ec1f375a3c5d391&pid=1-s2.0-S1441277223005185-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139038540","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}

{"title":"Protocol summary and statistical analysis plan for the low oxygen intervention for cardiac arrest injury limitation (LOGICAL) trial","authors":"Paul J. Young MBChB, PhD ,&nbsp;Carol L. Hodgson PT, MPhil, PhD ,&nbsp;Diane Mackle MN, PhD ,&nbsp;Anne M. Mather BBiomed (Hons) ,&nbsp;Richard Beasley MBChB, DSc ,&nbsp;Rinaldo Bellomo MD ,&nbsp;Stephen Bernard MD ,&nbsp;Kathy Brickell RGN ,&nbsp;Adam M. Deane PhD ,&nbsp;Glenn Eastwood PhD ,&nbsp;Simon Finfer MD ,&nbsp;Alisa M. Higgins MPH, PhD ,&nbsp;Anna Hunt BN ,&nbsp;Cassie Lawrence BN ,&nbsp;Natalie J. Linke BN ,&nbsp;Edward Litton MD, PhD ,&nbsp;Christine F. McDonald MBBS (Hons), PhD ,&nbsp;James Moore MBChB, MSc ,&nbsp;Alistair D. Nichol PhD ,&nbsp;Shaanti Olatunji MClinImm ,&nbsp;Jessica Kasza PhD","doi":"10.1016/j.ccrj.2023.06.007","DOIUrl":"10.1016/j.ccrj.2023.06.007","url":null,"abstract":"<div><h3>Background</h3><p>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.</p></div><div><h3>Objective</h3><p>The objective of this study was to summarise the protocol and statistical analysis plans for the LOGICAL trial.</p></div><div><h3>Design, setting, and participants</h3><p>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).</p></div><div><h3>Main outcome measures</h3><p>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).</p></div><div><h3>Conclusions</h3><p>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.</p></div><div><h3>Trial registration</h3><p>Australian and New Zealand Clinical Trials Registry (ACTRN12621000518864).</p></div>","PeriodicalId":49215,"journal":{"name":"Critical Care and Resuscitation","volume":"25 3","pages":"Pages 140-146"},"PeriodicalIF":2.9,"publicationDate":"2023-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"45456033","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}

{"title":"Erratum for previously published articles","authors":"","doi":"10.1016/j.ccrj.2023.09.001","DOIUrl":"https://doi.org/10.1016/j.ccrj.2023.09.001","url":null,"abstract":"","PeriodicalId":49215,"journal":{"name":"Critical Care and Resuscitation","volume":"25 3","pages":"Page 158"},"PeriodicalIF":2.9,"publicationDate":"2023-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"49711615","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}

{"title":"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","authors":"Matthew J. Summers MDiet ,&nbsp;Lee-anne S. Chapple MNutDiet, PhD ,&nbsp;Rinaldo Bellomo MBBS, MD ,&nbsp;Marianne J. Chapman MBBS, PhD ,&nbsp;Suzie Ferrie MND, PhD ,&nbsp;Mark E. Finnis MBBS, MBiostat ,&nbsp;Craig French MBBS ,&nbsp;Sally Hurford Post Grad Dip Clinical Research ,&nbsp;Nima Kakho MBBS ,&nbsp;Amalia Karahalios PhD ,&nbsp;Matthew J. Maiden MBBS, PhD ,&nbsp;Stephanie N. O'Connor RN, MNSc ,&nbsp;Sandra L. Peake MBBS, PhD ,&nbsp;Jeffrey J. Presneill MBBS, PhD ,&nbsp;Emma J. Ridley BNutDiet, PhD ,&nbsp;An Tran-Duy PhD ,&nbsp;Patricia J. Williams RGN, BNP ,&nbsp;Paul J. Young MBChB, PhD ,&nbsp;Sophie Zaloumis PhD ,&nbsp;Adam M. Deane MBBS, PhD","doi":"10.1016/j.ccrj.2023.08.001","DOIUrl":"https://doi.org/10.1016/j.ccrj.2023.08.001","url":null,"abstract":"<div><h3>Background</h3><p>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.</p></div><div><h3>Objective</h3><p>To describe the study protocol for the TARGET Protein trial.</p></div><div><h3>Design, setting, and participants</h3><p>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.</p></div><div><h3>Main outcomes measures</h3><p>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.</p></div><div><h3>Conclusion</h3><p>TARGET Protein aims to determine whether augmented enteral protein delivery reduces days free of the index hospital and alive at day 90.</p></div><div><h3>Trial registration</h3><p>Australian New Zealand Clinical Trials Registry (ACTRN12621001484831).</p></div>","PeriodicalId":49215,"journal":{"name":"Critical Care and Resuscitation","volume":"25 3","pages":"Pages 147-154"},"PeriodicalIF":2.9,"publicationDate":"2023-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"49711861","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}

{"title":"Current management of fluid balance in critically ill patients with acute kidney injury: A scoping review","authors":"Kyle C. White MBBS, MPH, FRACP, FCICM ,&nbsp;Ahmad Nasser MBChB, Dip. Child Health, M. Paed, FCICM ,&nbsp;Michelle L. Gatton PhD ,&nbsp;Kevin B. Laupland MD, PhD","doi":"10.1016/j.ccrj.2023.06.002","DOIUrl":"10.1016/j.ccrj.2023.06.002","url":null,"abstract":"<div><h3>Objective</h3><p>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).</p></div><div><h3>Introduction</h3><p>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.</p></div><div><h3>Inclusion criteria</h3><p>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.</p></div><div><h3>Methods</h3><p>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.</p></div><div><h3>Results</h3><p>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.</p></div><div><h3>Conclusions</h3><p>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.</p></div>","PeriodicalId":49215,"journal":{"name":"Critical Care and Resuscitation","volume":"25 3","pages":"Pages 126-135"},"PeriodicalIF":2.9,"publicationDate":"2023-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"48877915","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}

{"title":"Improving the management of medical emergency team calls due to suspected infections: A before–after study","authors":"Jeroen Ludikhuize MD, PhD ,&nbsp;David Marshall MD ,&nbsp;Misha Devchand MD, PhD ,&nbsp;Steven Walker MD, PhD ,&nbsp;Andrew Talman MD ,&nbsp;Carmel Taylor RN ,&nbsp;Tammie McIntyre RN ,&nbsp;Jason Trubiano MD, PhD ,&nbsp;Daryl Jones MD, PhD","doi":"10.1016/j.ccrj.2023.06.004","DOIUrl":"10.1016/j.ccrj.2023.06.004","url":null,"abstract":"<div><h3>Objective</h3><p>To introduce a management guideline for sepsis-related MET calls to increase lactate and blood culture acquisition, as well as prescription of appropriate antibiotics.</p></div><div><h3>Design</h3><p>Prospective before (Jun–Aug 2018) and after (Oct–Dec 2018) study was designed.</p></div><div><h3>Setting</h3><p>A public university linked hospital in Melbourne, Australia.</p></div><div><h3>Participants</h3><p>Adult patients with MET calls related to sepsis/infection were included.</p></div><div><h3>Main outcome measures</h3><p>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.</p></div><div><h3>Results</h3><p>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).</p></div><div><h3>Conclusions</h3><p>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.</p></div>","PeriodicalId":49215,"journal":{"name":"Critical Care and Resuscitation","volume":"25 3","pages":"Pages 136-139"},"PeriodicalIF":2.9,"publicationDate":"2023-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"46176287","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}

{"title":"Potential metrics for rapid response systems in Australia and New Zealand","authors":"Daryl Jones ,&nbsp;Judit Orosz ,&nbsp;Alex Psirides ,&nbsp;David Pilcher","doi":"10.1016/j.ccrj.2023.06.006","DOIUrl":"10.1016/j.ccrj.2023.06.006","url":null,"abstract":"","PeriodicalId":49215,"journal":{"name":"Critical Care and Resuscitation","volume":"25 3","pages":"Pages 116-117"},"PeriodicalIF":2.9,"publicationDate":"2023-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"44535203","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}

{"title":"Blend to Limit OxygEN in ECMO: A RanDomised ControllEd Registry (BLENDER) Trial: Study Protocol and Statistical Analysis Plan","authors":"Aidan Burrell PhD ,&nbsp;Sze Ng MBBS ,&nbsp;Kelly Ottosen MHealthSc ,&nbsp;Michael Bailey PhD ,&nbsp;Hergen Buscher MD ,&nbsp;John Fraser PhD ,&nbsp;Andrew Udy PhD ,&nbsp;David Gattas MMed(ClinEpi) ,&nbsp;Richard Totaro MBBS ,&nbsp;Rinaldo Bellomo PhD ,&nbsp;Paul Forrest MBChB ,&nbsp;Emma Martin BpharmSc ,&nbsp;Liadain Reid MPH ,&nbsp;Marc Ziegenfuss MBBS ,&nbsp;Glenn Eastwood PhD ,&nbsp;Alisa Higgins PhD ,&nbsp;Carol Hodgson PhD ,&nbsp;Edward Litton PhD ,&nbsp;Priya Nair PhD ,&nbsp;Neil Orford PhD ,&nbsp;David Pilcher MBBS","doi":"10.1016/j.ccrj.2023.06.001","DOIUrl":"https://doi.org/10.1016/j.ccrj.2023.06.001","url":null,"abstract":"<div><h3>Introduction</h3><p>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.</p></div><div><h3>Design</h3><p>The BLENDER trial is a pragmatic, multicentre, registry-embedded, randomised clinical trial., registered at <span>ClinicalTrials.gov</span><svg><path></path></svg> (NCT03841084) and approved by The Alfred Hospital Ethics Committee project ID HREC/50486/Alfred-2019.</p></div><div><h3>Participants and setting</h3><p>Patients supported by VA ECMO for cardiogenic shock or cardiac arrest who are enrolled in the Australian national ECMO registry.</p></div><div><h3>Intervention</h3><p>The study compares a conservative oxygenation strategy (target arterial saturations 92–96%) with a liberal oxygenation strategy (target 97–100%).</p></div><div><h3>Main Outcome Measures</h3><p>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.</p></div><div><h3>Conclusions</h3><p>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.</p></div>","PeriodicalId":49215,"journal":{"name":"Critical Care and Resuscitation","volume":"25 3","pages":"Pages 118-125"},"PeriodicalIF":2.9,"publicationDate":"2023-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"49711426","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}