Critical Care and Resuscitation最新文献

{"title":"Prevalence and characteristics of metaraminol usage in a large intensive care patient cohort. A multicentre, retrospective, observational study","authors":"Tarren Zimsen MBBS, MPH (Dr) ,&nbsp;Lachlan Quick MBBS, FCICM (Dr) ,&nbsp;Gentry White PhD (Prof) ,&nbsp;Rahul Costa-Pinto PhD (Dr) ,&nbsp;Stephen Whebell MBBS, FCICM (Dr) ,&nbsp;Jason Meyer BN, RN, MSc ,&nbsp;James McCullough FCICM, MMed (Dr) ,&nbsp;Kiran Shekar MBBS, FCICM, PhD (Prof) ,&nbsp;Kevin B. Laupland MD, PhD (Prof) ,&nbsp;Mahesh Ramanan BSc(Med), MBBS(Hons), MMed(Clin Epi), FCICM (Prof) ,&nbsp;Sebastiaan Blank FCICM (Dr) ,&nbsp;Alexis Tabah MD, FCICM (Prof) ,&nbsp;Stephen Luke MBBS, BSc(Hons), FCICM (Dr) ,&nbsp;Peter Garrett MBBS, BSc(hons), FCICM, FACEM, FCEM ,&nbsp;Antony G. Attokaran MBBS, FCICM, FRACP (Dr) ,&nbsp;Aashish Kumar MBBS, FCICM (Dr) ,&nbsp;Kyle C. White BSc, MPH, MBBS, FCICM, FRACP (Dr) ,&nbsp;the Queensland Critical Care Research Network (QCCRN)","doi":"10.1016/j.ccrj.2025.100112","DOIUrl":"10.1016/j.ccrj.2025.100112","url":null,"abstract":"<div><h3>Background</h3><div>Noradrenaline is the most prescribed vasopressor in intensive care units (ICUs). Although there is limited supporting evidence, metaraminol is often used as an alternative agent in some regions. We aimed to describe current practice and elucidate the factors associated with metaraminol prescription in a large cohort of ICU patients.</div></div><div><h3>Method</h3><div>A multicenter, retrospective cohort study of granular, routinely collected electronic medical record–based clinical data was performed in 12 ICUs in Queensland, Australia, between January 1, 2015, and December 31, 2021. Patients who received at least four consecutive hours of either metaraminol or noradrenaline in the first 24 h of their ICU stay were included.</div></div><div><h3>Results</h3><div>In total, 17,432 patients received single-agent vasopressor therapy and 1,963 (11.3 %) patients were administered metaraminol. For the entire cohort, the median age was 61 (interquartile range, IQR: 47–71), and the median Charlson Comorbidity Index was 3 (IQR: 1–5). The patients who received metaraminol had less ischaemic heart disease (5.5 % vs 7.6 %; p &lt; 0.001) and were more likely to have localised cancer (16 % vs 14 %; p &lt; 0.004). The patients receiving metaraminol were less likely to be ventilated on admission (39 % vs 73 %; p &lt; 0.001) and had lower median Acute Physiology and Chronic Health Evaluation III scores (51 vs 56; p &lt; 0.001). The median duration of metaraminol was 10 h (IQR: 6–18) and two-thirds (65 %) did not convert to noradrenaline infusion. After adjustment for confounders, after-hours admission (odds ratio, OR: 1.55; 95 % confidence interval [CI]: 1.40–1.71; p &lt; 0.001), treatment limitation orders (OR: 1.35; 95 % CI: 1.10–1.64; p &lt; 0.004), and admission to a regional ICU (OR: 1.47; 95 % CI: 1.27–1.68; p &lt; 0.001) were independently associated with metaraminol use.</div></div><div><h3>Conclusion</h3><div>Metaraminol is a widely used vasoconstrictor in Queensland ICUs. Patients who receive metaraminol have specific characteristics but are overall less unwell than patients who receive noradrenaline. Most patients who receive metaraminol do not require an alternative vasoactive medication.</div></div>","PeriodicalId":49215,"journal":{"name":"Critical Care and Resuscitation","volume":"27 2","pages":"Article 100112"},"PeriodicalIF":1.4,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144366521","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":"AI ethics for the everyday intensivist","authors":"Sing Chee Tan FCICM, MMed(ClinEpi), MIS(Health), MBBS(Hons) ,&nbsp;Lucy Modra FCICM, MPH, MBBS(Hons) ,&nbsp;Tamishta Hensman FCICM, MBBS","doi":"10.1016/j.ccrj.2025.100115","DOIUrl":"10.1016/j.ccrj.2025.100115","url":null,"abstract":"<div><div>In Australian intensive care units (ICUs), Artificial Intelligence (AI) promises to enhance efficiency and improve patient outcomes. However, ethical concerns surrounding AI must be addressed before widespread adoption. We examine the ethical challenges of of AI using the framework of the four pillars of biomedical ethics—beneficence, nonmaleficence, autonomy, and justice, and discuss the need for a fifth pillar of explicability. We consider the risks of perpetuating inequities, privacy breaches, and unintended harms, particularly in disadvantaged populations such as First Nations people. We advocate for a national strategy for ICUs to guide the ethical implementation of AI, that aligns with existing National AI Frameworks. Our recommendations for implementation of safe and ethical AI in ICU include education, developing guidelines, and ensuring transparency in AI decision-making. A coordinated strategy is essential to balance AI’s benefits with the ethical responsibility to protect patients and healthcare providers in critical care settings.</div></div>","PeriodicalId":49215,"journal":{"name":"Critical Care and Resuscitation","volume":"27 2","pages":"Article 100115"},"PeriodicalIF":1.4,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144481432","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":"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 ,&nbsp;Peinan Zhao PhD ,&nbsp;Allen C. Cheng MBBS, PhD ,&nbsp;Aaliya Ibrahim MClinEpid ,&nbsp;Jenna Hassall MPhil ,&nbsp;Edward Litton MBChB, PhD ,&nbsp;Christopher R. Andersen MBBS, FCICM ,&nbsp;Cindy Liang RN, GradCertN ,&nbsp;Elissa M. Milford MBBS, PhD ,&nbsp;Morgan Rose MBBS, PhD ,&nbsp;Mark Plummer FCICM, PhD ,&nbsp;Jing Kong RN, GradCertN ,&nbsp;Kerry Johnson RN, GradCertN ,&nbsp;Shailesh Bihari FCICM, PhD ,&nbsp;Anis Chaba MBBS, MMSBR ,&nbsp;Husna Begum PhD ,&nbsp;Sherene Magana Cruz DipLH ,&nbsp;Sze Ng MBBS ,&nbsp;Tony Trapani B.Ed ,&nbsp;Lewis Campbell MBChB, MSc Epi, FCICM ,&nbsp;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 &lt; 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}

{"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 ,&nbsp;Anthony Delaney FCICM, FACEM, PhD ,&nbsp;Andrew Udy FCICM, PhD ,&nbsp;Christopher Andersen FCICM, PhD ,&nbsp;Craig S. Anderson PhD ,&nbsp;Judith Bellapart FCICM, PhD ,&nbsp;Louise M. Burrell MBChB, MD ,&nbsp;Anthony Devaux PhD ,&nbsp;David M. Evans PhD ,&nbsp;Emily Fitzgerald RN, MN ,&nbsp;Tessa Garside FCICM, PhD ,&nbsp;Naomi Hammond RN, PhD ,&nbsp;Miranda Hardie BN, GradCertCritCare ,&nbsp;Rosalind L. Jeffree M.Sc, FRACS ,&nbsp;Serena Knowles RN, PhD ,&nbsp;Melissa Lassig-Smith RN ,&nbsp;Qiang Li AStat MBiostat ,&nbsp;Gladness Nethathe FCA (SA), Cert Crit Care (SA) ,&nbsp;Dorrilyn Rajbhandari PGDip Clin Nurs ,&nbsp;Mahesh Ramanan FCICM, PhD ,&nbsp;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}

{"title":"Expanding the critical care collaboration between Australia, New Zealand, and Brazil: The role of journals","authors":"Rinaldo Bellomo PhD ,&nbsp;Jorge Salluh PhD,&nbsp;Antonio Paulo Nassar Jr. PhD,&nbsp;Elisa Estenssoro PhD,&nbsp;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}

{"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 ,&nbsp;Diego Ariel Rey PhD ,&nbsp;David M. Evans PhD ,&nbsp;Lijing Yao PhD ,&nbsp;Simon Finfer MD ,&nbsp;Rinaldo Bellomo PhD ,&nbsp;Tiago Chedraoui Silva PhD ,&nbsp;Jeremy Cohen PhD ,&nbsp;Yu Qiu PhD ,&nbsp;Wellington dos Reis Lucena PhD ,&nbsp;Naomi Hammond PhD ,&nbsp;John Myburgh PhD ,&nbsp;Qiang Li PhD ,&nbsp;Lucas Petri Damiani PhD ,&nbsp;Anthony Devaux PhD ,&nbsp;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}

{"title":"Siloed thinking: The case for integrating economic and environmental analysis in critical care","authors":"Mark Collins FCICM ,&nbsp;Lisa Higgins PhD ,&nbsp;Scott McAlister PhD ,&nbsp;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}

{"title":"In memory of professor Rinaldo Bellomo: A giant of intensive care medicine","authors":"Ary Serpa Neto MD, MSc, PhD, FCICM ,&nbsp;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}

{"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 ,&nbsp;Mairead McNamara BAppSc, MDietPrac ,&nbsp;Jamie Cooper MD ,&nbsp;Tomoko Fujii MD, PhD ,&nbsp;Alisa Higgins PhD ,&nbsp;Carol Hodgson PhD ,&nbsp;Leanlove Navarra BSN ,&nbsp;Alistair Nichol MD, PhD ,&nbsp;Sandra Peake MD, PhD ,&nbsp;Alvaro Rea-Neto MD, MSc, PhD ,&nbsp;Paul Secombe BMBS(hons) MClinSc, FCICM ,&nbsp;Emily See MD ,&nbsp;Pam Taylor ,&nbsp;Meredith Young MPH ,&nbsp;Fernando G. Zampieri MD, PhD ,&nbsp;Paul Young PhD, FCICM ,&nbsp;Rinaldo Bellomo MD, PhD ,&nbsp;Andrew Udy MBChB, PhD ,&nbsp;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}

{"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 ,&nbsp;Marouane Boubaya MD ,&nbsp;Guillaume Louis MD ,&nbsp;Khalil Chaïbi MD, PhD ,&nbsp;Bruno Mégarbane MD, PhD ,&nbsp;Julien Bohe MD, PhD ,&nbsp;Maxime Desgrouas MD ,&nbsp;Guillaume Gele-Decaudin MD ,&nbsp;Adrien Joseph MD, PhD ,&nbsp;Etienne de Montmollin MD, PhD ,&nbsp;Christophe Camus MD, PhD ,&nbsp;Nicolas De Prost MD, PhD ,&nbsp;Pierre Bailly MD ,&nbsp;Samir Jaber MD, PhD ,&nbsp;Nicolas Chudeau MD ,&nbsp;Alexis Lambour MD ,&nbsp;Adrien Robine MD ,&nbsp;Béatrice La Combe MD, PhD ,&nbsp;Antoine Kimmoun MD, PhD ,&nbsp;Guillaume Chevrel MD ,&nbsp;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}