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. CONCLUSION: This study demonstrates that SDD significantly reduces infection in multiple trauma, although this RCT in 401 patients was underpowered to detect a mortality benefit.
RCT Entities:
OBJECTIVE: Evaluation of selective decontamination of the digestive tract (SDD) on late mortality in ventilated traumapatients in an intensive care unit (ICU). METHODS: A multicenter, randomized controlled trial was undertaken in 401 traumapatients 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. CONCLUSION: This study demonstrates that SDD significantly reduces infection in multiple trauma, although this RCT in 401 patients was underpowered to detect a mortality benefit.
Authors: Walter C Hellinger; Joseph D Yao; Salvador Alvarez; Janis E Blair; John J Cawley; Carlos V Paya; Peter C O'Brien; James R Spivey; Rolland C Dickson; Denise M Harnois; David D Douglas; Christopher B Hughes; Justin H Nguyen; David C Mulligan; Jeffrey L Steers Journal: Transplantation Date: 2002-06-27 Impact factor: 4.939
Authors: Luciano Silvestri; Marco Milanese; Luisa Oblach; Francesco Fontana; Dario Gregori; Romano Guerra; Hendrick K F van Saene Journal: Am J Infect Control Date: 2002-11 Impact factor: 2.918
Authors: H M Schardey; U Joosten; U Finke; K H Staubach; R Schauer; A Heiss; A Kooistra; H G Rau; R Nibler; S Lüdeling; K Unertl; G Ruckdeschel; H Exner; F W Schildberg Journal: Ann Surg Date: 1997-02 Impact factor: 12.969
Authors: Ioannis Pneumatikos; Vassilios Koulouras; Christodoulos Nathanail; Diana Goe; George Nakos Journal: Intensive Care Med Date: 2002-03-06 Impact factor: 17.440
Authors: Massimo Antonelli; Elie Azoulay; Marc Bonten; Jean Chastre; Giuseppe Citerio; Giorgio Conti; Daniel De Backer; François Lemaire; Herwig Gerlach; Johan Groeneveld; Goran Hedenstierna; Duncan Macrae; Jordi Mancebo; Salvatore M Maggiore; Alexandre Mebazaa; Philipp Metnitz; Jerme Pugin; Jan Wernerman; Haibo Zhang Journal: Intensive Care Med Date: 2008-01-31 Impact factor: 17.440