The effect of selective decontamination of the digestive tract on mortality in multiple trauma patients: a multicenter randomized controlled trial.
OBJECTIVE
Evaluation of selective decontamination of the digestive tract (SDD) on late mortality in ventilated trauma patients in an intensive care unit (ICU).


METHODS
A multicenter, randomized controlled trial was undertaken in 401 trauma patients with Hospital Trauma Index-Injury Severity Score of 16 or higher. Patients were randomized to control (n=200) or SDD (n=201), using polymyxin E, tobramycin, and amphotericin B in throat and gut throughout ICU treatment combined with cefotaxime for 4 days. Primary endpoint was late mortality excluding early death from hemorrhage or craniocerebral injury. Secondary endpoints were infection and organ dysfunction.


RESULTS
Mortality was 20.9% with SDD and 22.0% in controls. Overall late mortality was 15.3% (57/372) as 29 patients died from cerebral injury, 16 SDD and 13 control. The odds ratio (95% confidence intervals) of late mortality for SDD relative to control was 0.75 (0.40-1.37), corresponding to estimates of 13.4% SDD and 17.2% control. The overall infection rate was reduced in the test group (48.8% vs. 61.0%). SDD reduced lower airway infections (30.9% vs. 50.0%) and bloodstream infections due to aerobic Gram-negative bacilli (2.5% vs. 7.5%). No difference in organ dysfunction was found.


CONCLUSIONS
This study demonstrates that SDD significantly reduces infection in multiple trauma, although this RCT in 401 patients was underpowered to detect a mortality benefit.
Stoutenbeek
C P
CP
Department Intensive Care, Academic Medical Center, Amsterdam, The Netherlands.
van Saene
H K F
HK
Little
R A
RA
Whitehead
A
A
D000328:Adult; D000900:Anti-Bacterial Agents / Q000627:therapeutic use*; D001424:Bacterial Infections / Q000188:drug therapy*; D003666:Decontamination / Q000379:methods*; D005260:Female; D041981:Gastrointestinal Tract / Q000382:microbiology*; D006801:Humans; D015601:Injury Severity Score; D007362:Intensive Care Units; D008297:Male; D008875:Middle Aged; D009104:Multiple Trauma / Q000145:classification / Q000401:mortality / Q000628:therapy*; D012121:Respiration, Artificial
D000900:Anti-Bacterial Agents