ICU sedation, delirium & recovery

Mortality As a Measure of Treatment Effect in Clinical Trials Recruiting Critically Ill Patients*

Crit Care MedPublished Systematic review of randomised controlled trials

Authors' conclusion

Differential mortality effects persist for 60 to 90 days following recruitment. Location-based measures approximate time-based measures for trials conducted outside the United States. The documentation of a mortality reduction has had a modest impact on practice.

Study context

Population
Adult ICU-based randomized clinical trials (RCTs) (≥100 randomised, high-impact general medical or critical care journals, mortality at ≥2 time points), 1990–2018
Participants
228,784 participants · 343 RCTs
Outcome
Performance characteristics of all-cause mortality endpoint: temporal course, responsiveness to differential treatment effects, impact on practice
Methodological detailsmethodological review, adult ICU-based RCTs, ≥100 patients randomised
  • Methodological review
  • Adult ICU-based RCTs
  • ≥100 patients randomised

Pooled result

As reported in the abstract

Deaths by 180 days that had occurred by day 7
one third
Risk difference between arms continued to increase until day 60
p = 0.01
Risk difference possibly increased until day 90, stable thereafter
p = 0.07
Deaths at ICU discharge relative to deaths at 28-30 days
95% [interquartile range [IQR], 86-106%]
Deaths at hospital discharge relative to deaths at 60 days
99% [IQR, 94-104%]
Interventions showing mortality benefit adopted into widespread clinical practice
13 of 43 interventions (30.2%)

Original publication

Mortality As a Measure of Treatment Effect in Clinical Trials Recruiting Critically Ill Patients*. Crit Care Med. Published 20 January 2023. doi:10.1097/ccm.0000000000005721

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