Critical Care and Resuscitation最新文献

{"title":"Sonographic evaluation of intracranial hemodynamics and pressure after out-of-hospital cardiac arrest: An exploratory sub-study of the TAME trial","authors":"Halvor Ø. Guldbrandsen MD ,&nbsp;Peter Juhl-Olsen MD, PhD ,&nbsp;Glenn M. Eastwood MD, PhD ,&nbsp;Kasper L. Wethelund BMSc ,&nbsp;Anders M. Grejs MD, PhD","doi":"10.1016/j.ccrj.2024.06.001","DOIUrl":"10.1016/j.ccrj.2024.06.001","url":null,"abstract":"<div><h3>Objective</h3><p>Targeted mild hypercapnia is a potential neuroprotective therapy after cardiac arrest. In this exploratory observational study, we aimed to explore the effects of targeted mild hypercapnia on cerebral microvascular resistance assessed by middle cerebral artery pulsatility index (MCA PI) and intracranial pressure estimated by optic nerve sheath diameter (ONSD) in resuscitated out-of-hospital cardiac arrest (OHCA) patients.</p></div><div><h3>Design, setting, participants and interventions</h3><p>Comatose adults resuscitated from OHCA were randomly allocated to targeted mild hypercapnia (PaCO₂ 50–55 mmHg) or targeted normocapnia (PaCO₂ 35–45 mmHg) for 24 h in the TAME trial.</p></div><div><h3>Main outcome measures</h3><p>Using transcranial Doppler and transorbital ultrasound, we obtained MCA PI and ONSD at 4, 24, and 48 h after randomization. Ultrasound parameters were compared between groups using a linear mixed effects model.</p></div><div><h3>Results</h3><p>Twelve consecutive patients were included, with seven patients in the mild hypercapnia group. MCA PI decreased from 4 to 24 h (p = 0.019) and was lower over the first 24 h in patients allocated to targeted mild hypercapnia compared with targeted normocapnia (p = 0.047). ONSD did not differ between groups or over time.</p></div><div><h3>Conclusion</h3><p>Cerebral microvascular resistance assessed by MCA PI decreased over 24 h and was lower in OHCA patients treated with targeted mild hypercapnia compared with targeted normocapnia. Targeted mild hypercapnia did not exert substantial effect on intracranial pressure as estimated by ONSD.</p></div>","PeriodicalId":49215,"journal":{"name":"Critical Care and Resuscitation","volume":"26 3","pages":"Pages 176-184"},"PeriodicalIF":1.4,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S1441277224000164/pdfft?md5=f7af3cbe49d6aa5ac5495abd615c7474&pid=1-s2.0-S1441277224000164-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142230346","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":"A multicentre point prevalence study of nocturnal hours awake and enteral pharmacological sleep aids in patients admitted to Australian and New Zealand intensive care units","authors":"Laurie Showler MBChB ,&nbsp;Adam M. Deane MBBS PhD ,&nbsp;Edward Litton MBChB MSc ,&nbsp;Melissa J. Ankravs BPharm MClinPharm ,&nbsp;Bradley Wibrow MBBS MSc ,&nbsp;Deborah Barge RN RM CCRN ,&nbsp;Jeremy Goldin MBBS MM ,&nbsp;Naomi Hammond RN MN PhD ,&nbsp;Manoj K. Saxena MMBChir BSc ,&nbsp;Paul J. Young MBChB PhD ,&nbsp;Bala Venkatesh MBBS MD ,&nbsp;Mark Finnis MBBS MBiostat ,&nbsp;Yasmine Ali Abdelhamid MBBS PhD","doi":"10.1016/j.ccrj.2024.06.009","DOIUrl":"10.1016/j.ccrj.2024.06.009","url":null,"abstract":"<div><h3>Objective</h3><p>Critically ill patients suffer disrupted sleep. Hypnotic medications may improve sleep; however, local epidemiological data regarding the amount of nocturnal time awake and the use of such medications is needed.</p></div><div><h3>Design</h3><p>Point prevalence study.</p></div><div><h3>Setting</h3><p>Adult ICUs in Australia and New Zealand.</p></div><div><h3>Participants</h3><p>All adult patients admitted to participating Intensive Care Units (ICUs) on the study day.</p></div><div><h3>Main outcome measures</h3><p>Time awake overnight (22:00–06:00) was determined by structured nurse observation. The use of enterally administered sedative-hypnotic drugs prior to and during ICU admission was recorded, as was the use of a unit policy and non-pharmacological sleep promotion strategies.</p></div><div><h3>Results</h3><p>Data were available for 532 patients admitted to 40 ICUs (median age 60 years, 336 (63.2%) male, and 222 (41.7%) invasively ventilated). Forty-eight patients (9.0%) received an enteral pharmacological sleep aid, of which melatonin (28, 5.2%) was most frequently used. Patients not invasively ventilated were observed to be awake overnight for a median of 4.0 h (interquartile range (IQR): 2.5, 5.5), with no difference in those receiving an enteral hypnotic (p = 0.9). Non-pharmacological sleep aids were reportedly not offered or available for 52% (earplugs) and 63% of patients (eye masks). Only 7 (17.5%) participating ICUs had a policy informing sleep-optimising interventions.</p></div><div><h3>Conclusions</h3><p>Patients not receiving invasive ventilation appeared to spend many nocturnal hours awake. Pharmacological sleep aid administration was not associated with a greater observed time asleep. Most patients did not receive any non-pharmacological aid, and most ICUs did not have a local guideline or unit policy on sleep promotion.</p></div>","PeriodicalId":49215,"journal":{"name":"Critical Care and Resuscitation","volume":"26 3","pages":"Pages 192-197"},"PeriodicalIF":1.4,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S1441277224000255/pdfft?md5=57ab8f01891fcbe0c84f074506be7286&pid=1-s2.0-S1441277224000255-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142230348","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":"Recommendations for the College of Intensive Care Medicine (CICM) trainee research project: A modified Delphi study","authors":"Ariel Ho MBBS, MPhil ,&nbsp;Kerina J. Denny MBBS, PhD, FCICM ,&nbsp;Kevin B. Laupland MD, PhD, FCICM ,&nbsp;Mahesh Ramanan MBBS, FCICM ,&nbsp;Alexis Tabah MD, FCICM ,&nbsp;James McCullough MBBS, FCICM ,&nbsp;Jessica A. Schults RN, PhD ,&nbsp;Sainath Raman MBBS, FCICM","doi":"10.1016/j.ccrj.2024.05.002","DOIUrl":"10.1016/j.ccrj.2024.05.002","url":null,"abstract":"<div><h3>Objective</h3><p>To determine the perceived barriers and enablers to efficient completion of the College of Intensive Care Medicine (CICM) of Australia and New Zealand Formal Project – a trainee research project mandated for award of CICM Fellowship – and to develop consensus-based recommendations to support Intensive Care trainees and supervisors.</p></div><div><h3>Design</h3><p>A two-stage modified Delphi study was conducted. In stage one, an anonymous electronic survey was distributed with three targeted open-ended questions relating to perceived key steps, barriers to, and improvements for efficient completion of the Formal Project. A thematic analysis used the survey results to generate a list of close-ended questions.</p><p>In stage two, a consensus panel comprising of 30 panellists including CICM trainees, Formal Project supervisors and assessors, and critical care researchers, underwent a Delphi process with two rounds of voting and discussion to generate consensus-based recommendations.</p></div><div><h3>Setting</h3><p>Surveys were distributed to Intensive Care Units across Australia and New Zealand. The consensus panel convened at the Queensland Critical Care Research Network Annual Scientific Meeting in Redcliffe, Queensland, Australia, on 9 June 2023.</p></div><div><h3>Participants</h3><p>CICM trainees, Formal Project supervisors and assessors, and critical care researchers in Australia and New Zealand.</p></div><div><h3>Main outcome measures</h3><p>Consensus-based recommendations for the CICM Formal Project.</p></div><div><h3>Results</h3><p>We received 88 responses from the stage one survey. Stage two finalised 22 consensus-based recommendations, centring on key steps of the research process, resources for trainees, and support and training for supervisors.</p></div><div><h3>Conclusions</h3><p>Twenty-two recommendations were developed aiming to make the process of completing the mandatory CICM research project more efficient, and to improve the quality of research produced from these projects.</p></div>","PeriodicalId":49215,"journal":{"name":"Critical Care and Resuscitation","volume":"26 3","pages":"Pages 169-175"},"PeriodicalIF":1.4,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S1441277224000140/pdfft?md5=5354597ce9a4a669ec24af9fb32ed068&pid=1-s2.0-S1441277224000140-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142230261","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":"Corrigendum to “Statistical analysis plan for the biomarker-guided intervention to prevent acute kidney injury after major surgery (BigpAK-2) study: An international randomised controlled multicentre trial” Crit Care Resusc. 26(2) (2024) 80–86. eCollection 2024 Jun","authors":"Thilo von Groote ,&nbsp;Moritz Fabian Danzer ,&nbsp;Melanie Meersch ,&nbsp;Alexander Zarbock ,&nbsp;Joachim Gerß ,&nbsp;BigpAK-2 study group","doi":"10.1016/j.ccrj.2024.09.001","DOIUrl":"10.1016/j.ccrj.2024.09.001","url":null,"abstract":"","PeriodicalId":49215,"journal":{"name":"Critical Care and Resuscitation","volume":"26 3","pages":"Page 223"},"PeriodicalIF":1.4,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S1441277224000371/pdfft?md5=8fa51d241a2a1b6d0ee059ef3e516b83&pid=1-s2.0-S1441277224000371-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142230549","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":"While you were sleeping","authors":"Neil R. Orford MBBS, FCICM, FANZCA, PGDipEcho, PhD","doi":"10.1016/j.ccrj.2024.06.007","DOIUrl":"10.1016/j.ccrj.2024.06.007","url":null,"abstract":"","PeriodicalId":49215,"journal":{"name":"Critical Care and Resuscitation","volume":"26 3","pages":"Page 222"},"PeriodicalIF":1.4,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S144127722400022X/pdfft?md5=7bf9b865c204384263578a2fc2254a82&pid=1-s2.0-S144127722400022X-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142230450","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":"Effect of automated titration of oxygen on time spent in a prescribed oxygen saturation range in adults in the ICU after cardiac surgery","authors":"Louis W. Kirton MBChB ,&nbsp;Raulle Sol Cruz BSN ,&nbsp;Leanlove Navarra BSN ,&nbsp;Allie Eathorne BSc ,&nbsp;Julie Cook MBChB ,&nbsp;Richard Beasley DSc ,&nbsp;Paul J. Young MBChB, PhD","doi":"10.1016/j.ccrj.2024.01.001","DOIUrl":"10.1016/j.ccrj.2024.01.001","url":null,"abstract":"<div><h3>Objective</h3><p>The objective of this study was to determine whether automated titration of the fraction of inspired oxygen (FiO₂) increases the time spent with oxygen saturation (SpO₂) within a predetermined target SpO₂ range compared with manually adjusted high-flow oxygen therapy in postoperative cardiac surgical patients managed in the intensive care unit (ICU).</p></div><div><h3>Design</h3><p>Single-centre, open-label, randomised clinical trial.</p></div><div><h3>Setting</h3><p>Tertiary centre ICU.</p></div><div><h3>Participants</h3><p>Recently extubated adults following elective cardiac surgery who required supplemental oxygen.</p></div><div><h3>Interventions</h3><p>Automatically adjusted FiO₂ (using an automated oxygen control system) compared with manual FiO₂ titration, until cessation of oxygen therapy, ICU discharge, or 24 h (whichever was sooner).</p></div><div><h3>Main outcome measures</h3><p>The primary outcome was the proportion of time receiving oxygen therapy with the SpO₂ in a SpO₂ target range of 92–96 %.</p></div><div><h3>Results</h3><p>Among 65 participants, the percentage of time per patient spent in the target SpO₂ range was a median of 97.7 % (interquartile range: 87.9–99.2 %) and 91.3 % (interquartile range: 77.1–96.1 %) in the automated (n = 28) and manual (n = 28) titration groups, respectively. The estimated effect of automated FiO₂, compared to manual FiO₂ titration, was to increase the percentage of time spent in the target range by a median of 4.8 percentage points (95 % confidence interval: 1.6 to 10.3 percentage points, p = 0.01).</p></div><div><h3>Conclusion</h3><p>In patients recently extubated after cardiac surgery, automated FiO₂ titration significantly increased time spent in a target SpO₂ range of 92–96 % compared to manual FiO₂ titration.</p></div>","PeriodicalId":49215,"journal":{"name":"Critical Care and Resuscitation","volume":"26 2","pages":"Pages 64-70"},"PeriodicalIF":1.4,"publicationDate":"2024-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S1441277224000012/pdfft?md5=d919093c4ea4da4a465fbf8f92c3ea67&pid=1-s2.0-S1441277224000012-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140401657","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 truism of ‘life limiting illness’ in ICU","authors":"Ashwin Subramaniam MBBS, GChPOM, MMed, FRACP, FCICM, PhD,&nbsp;Ryan Ruiyang Ling MBBS,&nbsp;Jai Darvall MBBS, GChPOM, MEpid, FANZCA, FCICM, PhD","doi":"10.1016/j.ccrj.2024.06.003","DOIUrl":"https://doi.org/10.1016/j.ccrj.2024.06.003","url":null,"abstract":"","PeriodicalId":49215,"journal":{"name":"Critical Care and Resuscitation","volume":"26 2","pages":"Pages 61-63"},"PeriodicalIF":1.4,"publicationDate":"2024-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S1441277224000188/pdfft?md5=d2ba88bfb9db1f02c90c8e0a82d1521d&pid=1-s2.0-S1441277224000188-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141483211","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":"Prevalence and long-term outcomes of patients with life-limiting illness admitted to intensive care units in Australia and New Zealand","authors":"Kate Wagner MBBS, M Bioeth ,&nbsp;Neil Orford MBBS, FCICM, FANZCA, PGDipEcho, PhD ,&nbsp;Sharyn Milnes RN, PGCertCCN, PGDipEd, MBioeth, PhD ,&nbsp;Paul Secombe BMBS(Hons), MClinSc, FCICM ,&nbsp;Steve Philpot MBBS (Hons), FANZCA, FCICM, PGDipEcho, MHealth&MedLaw, GChPOM ,&nbsp;David Pilcher MBBS, FCICM, FRACP","doi":"10.1016/j.ccrj.2024.02.001","DOIUrl":"https://doi.org/10.1016/j.ccrj.2024.02.001","url":null,"abstract":"<div><h3>Objective</h3><p>Determine the prevalence and outcomes of patients with life-limiting illness (LLI) admitted to Australian and New Zealand Intensive Care Units (ICUs).</p></div><div><h3>Design, setting, participants</h3><p>Retrospective registry-linked observational cohort study of all adults admitted to Australian and New Zealand ICUs from 1st January 2018 until 31st December 2020 (New Zealand) and 31st March 2022 (Australia), recorded in the Australian and New Zealand Intensive Care Society Adult Patient Database.</p></div><div><h3>Main outcome measures</h3><p>The primary outcome was 1-year mortality. Secondary outcomes included ICU and hospital mortality, ICU and hospital length of stay, and 4-year survival.</p></div><div><h3>Results</h3><p>A total of 566,260 patients were included, of whom 129,613 (22.9%) had one or more LLI. Mortality at one year was 28.1% in those with LLI and 10.4% in those without LLI (p &lt; 0.001). Mortality in intensive care (6.8% v 3.4%, p &lt; 0.001), hospital (11.8% v 5.0%, p &lt; 0.001), and at two (36.6% v 14.1%, p &lt; 0.001), three (43.7% v 17.7%, p &lt; 0.001) and four (55.6% v 24.5%, p &lt; 0.001) years were all higher in the cohort of patients with LLI. Patients with LLI had a longer ICU (1.9 [0.9, 3.7] v 1.6 [0.9, 2.9] days, p &lt; 0.001) and hospital length of stay (8.8 [49,16.0] v 7.2 [3.9, 12.9] days, p &lt; 0.001), and were more commonly readmitted to ICU during the same hospitalisation than patients without LLI (5.2% v 3.7%, p &lt; 0.001). After multivariate analysis the LLI with the strongest adverse effect on survival was frailty (HR 2.08, 95% CI 2.03 to 2.12, p &lt; 0.001), followed by the presence of metastatic cancer (HR 1.97, 95% CI 1.92 to 2.02, p &lt; 0.001), and chronic liver disease (HR 1.65, 95% CI 1.65 to 1.71, p &lt; 0.001).</p></div><div><h3>Conclusion</h3><p>Patients with LLI account for almost a quarter of ICU admissions in Australia and New Zealand, require prolonged ICU and hospital care, and have high mortality in subsequent years. This knowledge should be used to identify this vulnerable cohort of patients, and to ensure that treatment is aligned to each patient's values and realistic goals.</p></div>","PeriodicalId":49215,"journal":{"name":"Critical Care and Resuscitation","volume":"26 2","pages":"Pages 116-122"},"PeriodicalIF":1.4,"publicationDate":"2024-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S1441277224000048/pdfft?md5=cf5cf03517b366ba43e008fcb7f1313f&pid=1-s2.0-S1441277224000048-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141486191","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":"Statistical analysis plan for the biomarker-guided intervention to prevent acute kidney injury after major surgery (BigpAK-2) study: An international randomised controlled multicentre trial","authors":"Thilo von Groote MD ,&nbsp;Moritz Fabian Danzer MSc ,&nbsp;Melanie Meersch MD ,&nbsp;Alexander Zarbock MD ,&nbsp;Joachim Gerß PhD","doi":"10.1016/j.ccrj.2024.03.001","DOIUrl":"https://doi.org/10.1016/j.ccrj.2024.03.001","url":null,"abstract":"<div><h3>Objective</h3><p>This article describes the statistical analysis plan for the Biomarker-guided intervention to prevent AKI after major surgery (BigpAK-2) trial.</p></div><div><h3>Design</h3><p>Adaptive trial design with an interim analysis after enrolment of 618 evaluable patients.</p></div><div><h3>Setting</h3><p>The BigpAK.-2 trial is an international, prospective, randomised controlled multicentre study.</p></div><div><h3>Participants</h3><p>The BigpAK-2 study enrols patients after major surgery who are admitted to the intensive care or high dependency unit and are at high-risk for postoperative AKI as identified by urinary biomarkers (tissue inhibitor of metalloproteinases-2 and insulin-like growth factor binding protein 7 ([TIMP-2]∗[IGFBP7]) will be enrolled.</p></div><div><h3>Intervention</h3><p>Patients are randomly and evenly allocated to standard of care (control) group or the implementation of a nephroprotective care bundle (intervention group), as recommended by the Kidney Disease: Improving Global Outcomes (KDIGO) guidelines. The KDIGO care bundle recommends discontinuation of nephrotoxic agents if possible, ensuring adequate volume status and perfusion pressure, considering functional haemodynamic monitoring, regular monitoring of serum creatinine and urine output, avoiding hyperglycemia, and considering alternatives to radiocontrast procedures when possible.</p></div><div><h3>Results</h3><p>The BigpAK-2 study investigates whether the biomarker-gudied implementation of the KDIGO care bundle reduces the incidence of moderate or severe AKI (stage 2 or 3), according to the KDIGO 2012 criteria, within 72 h after surgery.</p></div><div><h3>Conclusion</h3><p>AKI is a common and often severe complication after major surgery. As no specific treatments exist, prevention of AKI is of high importance. The BigpAK-2 study investigates a promising approach to prevent AKI after major surgery.</p></div><div><h3>Trial registration</h3><p>The trial was registered prior to start at <span>clinicaltrials.gov</span><svg><path></path></svg>; NCT04647396.</p></div>","PeriodicalId":49215,"journal":{"name":"Critical Care and Resuscitation","volume":"26 2","pages":"Pages 80-86"},"PeriodicalIF":1.4,"publicationDate":"2024-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S1441277224000061/pdfft?md5=7603b8051ebdcce17d01c61033c5963a&pid=1-s2.0-S1441277224000061-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141486284","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":"Statistical analysis plan for the SQUEEZE trial: A trial to determine whether septic shock reversal is quicker in pediatric patients randomized to an early goal-directed fluid-sparing strategy vs. usual care (SQUEEZE)","authors":"Melissa J. Parker MD, MSc ,&nbsp;Gary Foster PhD ,&nbsp;Alison Fox-Robichaud MD, MSc ,&nbsp;Karen Choong MB BCh, MSc ,&nbsp;Lawrence Mbuagbaw MD, PhD ,&nbsp;Lehana Thabane PhD ,&nbsp;With the SQUEEZE Trial Steering Committee and on behalf of the SQUEEZE Trial Investigators, the Canadian Critical Care Trials Group, Pediatric Emergency Research Canada, and the Canadian Critical Care Translational Biology Group","doi":"10.1016/j.ccrj.2024.02.002","DOIUrl":"https://doi.org/10.1016/j.ccrj.2024.02.002","url":null,"abstract":"<div><h3>Background</h3><p>The SQUEEZE trial is a multicentred randomized controlled trial which seeks to determine the optimal approach to fluid resuscitation in paediatric septic shock. SQUEEZE also includes a nested translational study, SQUEEZE-D, investigating the value of plasma cell-free DNA for prediction of clinical outcomes.</p></div><div><h3>Objective</h3><p>To present a pre-specified statistical analysis plan (SAP) for the SQUEEZE trial prior to finalizing the trial data set and prior to commencing data analysis.</p></div><div><h3>Design</h3><p>SQUEEZE is a pragmatic, two-arm, open-label, prospective multicentre randomized controlled trial.</p></div><div><h3>Setting</h3><p>Canadian paediatric tertiary care centres.</p></div><div><h3>Participants</h3><p>Paediatric patients with suspected sepsis and persistent signs of shock in need of ongoing resuscitation. Sample size target: 400 participants.</p></div><div><h3>Interventions</h3><p>The trial is designed to compare a fluid-sparing resuscitation strategy to usual care.</p></div><div><h3>Main outcome measures</h3><p>The primary outcome for the SQUEEZE trial is the time to shock reversal (in hours). The primary outcome analysis will assess the difference in time to shock reversal between the intervention and control groups, reported as point estimate with 95% confidence intervals. The statistical test for the primary analysis will be a two-sided t-test. Secondary outcome measures include clinical outcomes and adverse events including measures of organ dysfunction and mortality outcomes.</p></div><div><h3>Results</h3><p>The SAP presented here is reflective of and where necessary clarifies in detail the analysis plan as presented in the trial protocol. The SAP includes a mock CONSORT diagram, figures and tables. Data collection methods are summarized, primary and secondary outcomes are defined, and outcome analyses are described.</p></div><div><h3>Conclusions</h3><p>We have developed a statistical analysis plan for the SQUEEZE Trial for transparency and to align with best practices. Analysis of SQUEEZE Trial data will adhere to the SAP to reduce the risk of bias.</p></div><div><h3>Registration</h3><p>ClinicalTrials.gov identifiers: Definitive trial NCT03080038; Registered Feb 28, 2017. Pilot Trial NCT 01973907; Registered Oct 27, 2013.</p></div>","PeriodicalId":49215,"journal":{"name":"Critical Care and Resuscitation","volume":"26 2","pages":"Pages 123-134"},"PeriodicalIF":1.4,"publicationDate":"2024-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S144127722400005X/pdfft?md5=53a156cc434d1a572db1b8d0726b35e8&pid=1-s2.0-S144127722400005X-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141486287","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}