scholarly journals Targeted hypothermia versus targeted normothermia after out-of-hospital cardiac arrest: a statistical analysis plan

Trials ◽  
2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Janus Christian Jakobsen ◽  
Josef Dankiewicz ◽  
Theis Lange ◽  
Tobias Cronberg ◽  
Gisela Lilja ◽  
...  
Keyword(s):  
Cardiac Arrest ◽  
Statistical Analysis ◽  
Absolute Risk ◽  
Absolute Risk Reduction ◽  
Statistical Analysis Plan ◽  
Temperature Management ◽  
Parallel Group ◽  
Detailed Statistical Analysis ◽  
Superiority Trial ◽  
Hospital Cardiac Arrest

Abstract Background To date, targeted temperature management (TTM) is the only neuroprotective intervention after resuscitation from cardiac arrest that is recommended by guidelines. The evidence on the effects of TTM is unclear. Methods/design The Targeted Hypothermia Versus Targeted Normothermia After Out-of-hospital Cardiac Arrest (TTM2) trial is an international, multicentre, parallel group, investigator-initiated, randomised, superiority trial in which TTM with a target temperature of 33 °C after cardiac arrest will be compared with a strategy to maintain normothermia and active treatment of fever (≥ 37.8 °C). Prognosticators, outcome assessors, the steering group, the trial coordinating team, and trial statisticians will be blinded to treatment allocation. The primary outcome will be all-cause mortality at 180 days after randomisation. We estimate a 55% mortality in the targeted normothermia group. To detect an absolute risk reduction of 7.5% with an alpha of 0.05 and 90% power, 1900 participants will be enrolled. The secondary neurological outcome will be poor functional outcome (modified Rankin scale 4–6) at 180 days after cardiac arrest. In this paper, a detailed statistical analysis plan is presented, including a comprehensive description of the statistical analyses, handling of missing data, and assessments of underlying statistical assumptions. Final analyses will be conducted independently by two qualified statisticians following the present plan. Discussion This SAP, which was prepared before completion of enrolment, should increase the validity of the TTM trial by mitigation of analysis-bias.

scholarly journals Statistical Analysis Plan for the HydrOxychloroquine Prophylaxis Evaluation (HOPE) trial

2021 ◽  
Author(s):  
Arpita Ghosh ◽  
Amritendu Bhattacharya ◽  
Vivekanand Jha ◽  
Bharath Kumar Tirupakuzhi Vijayaraghavan ◽  
Abhinav Bassi ◽  
...  
Keyword(s):  
Statistical Analysis ◽  
Healthcare Workers ◽  
Controlled Trial ◽  
Statistical Analysis Plan ◽  
Protective Equipment ◽  
Standard Practice ◽  
Randomized Controlled ◽  
Parallel Group ◽  
Detailed Statistical Analysis ◽  
Frontline Healthcare Workers

HOPE is a prospective, multi-centre, parallel group, concealed, unblinded, randomized, controlled trial to determine whether combination of hydroxychloroquine and standard practice, that is, use of recommended personal protective equipment reduces the proportion of laboratory confirmed COVID-19 infections among frontline healthcare workers in hospitals in India as compared to standard practice. This detailed statistical analysis plan was prepared by trial statisticians and approved by the HOPE management committee prior to completion of data collection.

scholarly journals Statistical Analysis Plan for the Plasma-Lyte 148® versUs Saline Study (PLUS) trial

2020 ◽  
Author(s):  
Laurent Billot ◽  
Simon Finfer ◽  
Sharon Micallef
Keyword(s):  
Statistical Analysis ◽  
Fluid Resuscitation ◽  
Controlled Trial ◽  
Statistical Analysis Plan ◽  
Project Manager ◽  
Chief Investigator ◽  
Crystalloid Solution ◽  
Parallel Group ◽  
Detailed Statistical Analysis ◽  
Randomised Controlled

PLUS study is a prospective, multi-centre, parallel group, concealed, blinded, randomised, controlled trial to determine whether fluid resuscitation and therapy with a “balanced” crystalloid solution (Plasma-Lyte 148®) decreases 90-day mortality in critically ill patients requiring fluid resuscitation when compared with the same treatment using 0.9% sodium chloride (saline). This detailed statistical analysis plan (SAP) was written by the trial statistician, chief investigator and project manager and approved by the PLUS management committee prior to unblinding and completion of data collection.

scholarly journals Echocardiographic parameters during prolonged targeted temperature Management in out-of-hospital Cardiac Arrest Survivors to predict neurological outcome – a post-hoc analysis of the TTH48 trial

2021 ◽  
Vol 29 (1) ◽  
Author(s):  
Thomas Hvid Jensen ◽  
Peter Juhl-Olsen ◽  
Bent Roni Ranghøj Nielsen ◽  
Johan Heiberg ◽  
Christophe Henri Valdemar Duez ◽  
...  
Keyword(s):  
Cardiac Arrest ◽  
Neurological Outcome ◽  
Global Longitudinal Strain ◽  
Left Ventricular ◽  
Targeted Temperature Management ◽  
Temperature Management ◽  
Left Ventricular Ejection ◽  
Secondary Outcome ◽  
Ventricular Ejection Fraction ◽  
Hospital Cardiac Arrest

Abstract Background Transthoracic echocardiographic (TTE) indices of myocardial function among survivors of out-of-hospital cardiac arrest (OHCA) have been related to neurological outcome; however, results are inconsistent. We hypothesized that changes in average peak systolic mitral annular velocity (s’) from 24 h (h) to 72 h following start of targeted temperature management (TTM) predict six-month neurological outcome in comatose OHCA survivors. Methods We investigated the association between peak systolic velocity of the mitral plane (s’) and six-month neurological outcome in a population of 99 patients from a randomised controlled trial comparing TTM at 33 ± 1 °C for 24 h (h) (n = 47) vs. 48 h (n = 52) following OHCA (TTH48-trial). TTE was conducted at 24 h, 48 h, and 72 h after reaching target temperature. The primary outcome was 180 days neurological outcome assessed by Cerebral Performance Category score (CPC180) and the primary TTE outcome measure was s’. Secondary outcome measures were left ventricular ejection fraction (LVEF), global longitudinal strain (GLS), e’, E/e’ and tricuspid annular plane systolic excursion (TAPSE). Results Across all three scan time points s’ was not associated with neurological outcome (ORs: 24 h: 1.0 (95%CI: 0.7–1.4, p = 0.98), 48 h: 1.13 (95%CI: 0.9–1.4, p = 0.34), 72 h: 1.04 (95%CI: 0.8–1.4, p = 0.76)). LVEF, GLS, E/e’, and TAPSE recorded on serial TTEs following OHCA were neither associated with nor did they predict CPC180. Estimated median e’ at 48 h following TTM was 5.74 cm/s (95%CI: 5.27–6.22) in patients with good outcome (CPC180 1–2) vs. 4.95 cm/s (95%CI: 4.37–5.54) in patients with poor outcome (CPC180 3–5) (p = 0.04). Conclusions s’ assessed on serial TTEs in comatose survivors of OHCA treated with TTM was not associated with CPC180. Our findings suggest that serial TTEs in the early post-resuscitation phase during TTM do not aid the prognostication of neurological outcome following OHCA. Trial registration NCT02066753. Registered 14 February 2014 – Retrospectively registered,

Effects of Targeted Temperature Management in Patients with Post-Cardiac Arrest Syndrome after an Out-Of-Hospital Cardiac Arrest Caused by Hanging: A Prospective Observational Cohort Study in Japan

2021 ◽  
Author(s):  
Ryuichiro Kakizaki ◽  
Naofumi Bunya ◽  
Shuji Uemura ◽  
Takehiko Kasai ◽  
Keigo Sawamoto ◽  
...  
Keyword(s):  
Logistic Regression ◽  
Cardiac Arrest ◽  
Propensity Score ◽  
Multivariate Logistic Regression Analysis ◽  
Targeted Temperature Management ◽  
Temperature Management ◽  
Matched Cohort ◽  
Neurological Outcomes ◽  
Post Cardiac Arrest Syndrome ◽  
Hospital Cardiac Arrest

Abstract Background: Targeted temperature management (TTM) is recommended for unconscious patients after a cardiac arrest. However, its effectiveness in patients with post-cardiac arrest syndrome (PCAS) by hanging remains unclear. Therefore, this study aimed to investigate the relationship between TTM and favorable neurological outcomes in patients with PCAS by hanging.Methods: This study was a retrospective analysis of the Japanese Association for Acute Medicine out-of-hospital cardiac arrest (OHCA) registry between June 2014 and December 2017 among patients with PCAS admitted to the hospitals after an OHCA caused by hanging. A multivariate logistic regression analysis was performed to estimate the propensity score and to predict whether patients with PCAS by hanging receive TTM. We compared patients with PCAS by hanging who received TTM (TTM group) and those who did not (non-TTM group) using propensity score analysis.Results: A total of 199 patients with PCAS by hanging were enrolled in this study. Among them, 43 were assigned to the TTM group and 156 to the non-TTM group. Logistic regression model adjusted for propensity score revealed that TTM was not associated with favorable neurological outcome at 1-month (adjusted odds ratio [OR]: 1.38, 95% confidence interval [CI]: 0.27–6.96). Moreover, no difference was observed in the propensity score-matched cohort (adjusted OR: 0, 73, 95% CI: 0.10–4.71) and in the inverse probability of treatment weighting-matched cohort (adjusted OR: 0.63, 95% CI: 0.15–2.69).Conclusions: TTM was not associated with increased favorable neurological outcomes at 1-month in patients with PCAS after OHCA by hanging.

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