by Santacruz, Carlos A.; Pereira, Adriano J.; Celis, Edgar;
Vincent, Jean-Louis
Objectives: To
determine which multicenter randomized controlled trials in critically ill
patients have shown that the study intervention was associated with a
statistically significant reduction in mortality. Our analysis provides an
update to a report published 10 years ago.
Data Sources:
MEDLINE database and PubMed interface from inception until April 30, 2019.
Study Selection:
All adult multicenter randomized controlled trials that evaluated the effects
of any intervention or monitoring system in critically ill patients and
reported mortality as a primary or secondary outcome were included.
Data Extraction:
Numbers of centers and patients, type of intervention, reported mortality
outcome, and rate and level of significance were extracted into predefined
tables. Included randomized controlled trials were classified as reporting
reduced, increased, or no effect of the intervention on mortality. Methodologic
quality of trials was evaluated using the updated Consolidated Standards of
Reporting Trials statement.
Data Synthesis: A
total of 212 trials met the inclusion criteria: 27 (13%) reported a significant
reduction in mortality, 16 (7%) an increase in mortality, and 170 (80%) no
difference in mortality (one study was reported in 2 groups). Of the 27 trials
reporting reduced mortality, six had assessed interventions likely to decrease
ventilator-induced lung injury, including low tidal volume, prone position, and
neuromuscular blockers, demonstrating the negative effects of mechanical
ventilation strategies or improved process of care rather than positive effects
of new therapies. Seven of the 27 trials reported beneficial effects of
noninvasive ventilation. Results from some positive randomized controlled
trials, for example, studies of recombinant activated protein C, talactoferrin,
interleukin-1 receptor antagonist in sepsis, and muscle relaxants in severe
acute respiratory distress syndrome were not replicated in subsequent
randomized controlled trials. Other interventions, for example, gastric
tonometry, have been abandoned.
Conclusions: A
systematic literature search provided no conclusive evidence of any
pharmacologic intervention that has consistently reduced mortality in
critically ill patients. Strategies associated with improved or noninvasive
mechanical ventilation were associated with reduced mortality.
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