by Bourcier, Simon; Hindlet, Patrick; Guidet, Bertrand;
Dechartres, Agnès
Objectives: Many
recent randomized controlled trials in the field of septic shock failed to
demonstrate a benefit on mortality. Randomized controlled trials increasingly
report organ support duration and organ support-free days as primary or
secondary outcomes. We conducted a methodologic systematic review to assess how
organ support outcomes were defined and reported in septic shock randomized
controlled trials.
Data Sources:
MEDLINE via PubMed, Embase, Cochrane Central Register of Controlled Trials, and
Web of Science.
Study Selection:
We included randomized controlled trials published between January 2004 and
March 2018 that involved septic shock adults and assessed organ support
duration and/or organ support-free days for hemodynamic support, respiratory
support, or renal replacement therapy.
Data
Extraction: For each randomized controlled trial, we extracted the
definitions of organ support duration and organ support-free days. We
particularly evaluated how nonsurvivors were accounted for. Study authors were contacted
to provide any missing information regarding these definitions. Data Synthesis: We included 28
randomized controlled trials. Organ support duration and organ support-free
days outcomes were reported in 17 and 15 randomized controlled trials, respectively,
for hemodynamic support, 15 and 15 for respiratory support, and five and nine
for renal replacement therapy. Nonsurvivors were included in the organ support
duration calculation in 13 of 14 randomized controlled trials (93%) for
hemodynamic support and nine of 10 (90%) for respiratory support. The organ
support-free days definition for hemodynamic support, respiratory support, and
renal replacement therapy was reported in six of 15 randomized controlled
trials (40%), eight of 15 randomized controlled trials (53%), and six of nine
randomized controlled trials (67%) reporting an organ support-free days
outcome, respectively. Of these, one half assigned “0” to nonsurvivors, and the
other half attributed one point per day alive free of organ support up to a
predefined time point. Conclusions:
This study highlights the heterogeneity and infrequency of organ support
duration/organ support-free days outcome reporting in septic shock trials. When
reported, the definitions of these outcome measures and methods of calculation
are also infrequently reported, in particular how nonsurvivors were accounted
for, which may have an important impact on interpretation.
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