SuDDICU (post-hoc analysis)
Trial question
What is the role of selective digestive tract decontamination in critically ill patients with acute brain injury receiving mechanical ventilation?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
36.0% female
64.0% male
N = 2061
2061 patients (750 female, 1311 male).
Inclusion criteria: mechanically ventilated critically ill adults admitted to the ICU with acute brain injury.
Key exclusion criteria: known allergy, sensitivity, or interaction to trial topical intervention drugs; pregnancy; moribund and estimated survival < 12 hours; age < 16 years.
Interventions
N=968 selective digestive tract decontamination (6-hourly application of an oral paste and administration of a gastric suspension containing colistin, tobramycin, and nystatin for the duration of mechanical ventilation, plus a 4-day course of an intravenous antibiotic with a suitable antimicrobial spectrum).
N=1093 standard care (no selective digestive tract decontamination).
Primary outcome
All-cause in-hospital mortality at day 90
32.3%
38%
38.0 %
28.5 %
19.0 %
9.5 %
0.0 %
Selective digestive tract
decontamination
Standard
care
Significant
decrease ▼
NNT = 17
Significant decrease in all-cause in-hospital mortality at day 90 (32.3% vs. 38%; OR 0.76, 95% CI 0.63 to 0.92).
Secondary outcomes
Significant decrease in ICU mortality (25.5% vs. 29.6%; OR 0.79, 95% CI 0.65 to 0.97).
Significant increase in mean days alive and free of mechanical ventilation (57.2 days vs. 52.1 days; AD 5.6 days, 95% CI 2.17 to 9.03).
Significant increase in mean days alive and free of ICU admission (54 days vs. 49.2 days; AD 5.18 days, 95% CI 1.85 to 8.5).
Safety outcomes
No significant difference in adverse events.
Conclusion
In mechanically ventilated critically ill adults admitted to the ICU with acute brain injury, selective digestive tract decontamination was superior to standard care with respect to a all-cause in-hospital mortality at day 90.
Reference
Paul J Young, Anthony Devaux, Qiang Li et al. Selective digestive tract decontamination in critically ill adults with acute brain injuries: a post hoc analysis of a randomized clinical trial. Intensive Care Med. 2024 Jan;50(1):56-67.
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