Decontamination of the digestive tract and oropharynx in ICU patients.
de Smet AMGA., Kluytmans JAJW., Cooper BS., Mascini EM., Benus RFJ., van der Werf TS., van der Hoeven JG., Pickkers P., Bogaers-Hofman D., van der Meer NJM., Bernards AT., Kuijper EJ., Joore JCA., Leverstein-van Hall MA., Bindels AJGH., Jansz AR., Wesselink RMJ., de Jongh BM., Dennesen PJW., van Asselt GJ., te Velde LF., Frenay IHME., Kaasjager K., Bosch FH., van Iterson M., Thijsen SFT., Kluge GH., Pauw W., de Vries JW., Kaan JA., Arends JP., Aarts LPHJ., Sturm PDJ., Harinck HIJ., Voss A., Uijtendaal EV., Blok HEM., Thieme Groen ES., Pouw ME., Kalkman CJ., Bonten MJM.
BACKGROUND: Selective digestive tract decontamination (SDD) and selective oropharyngeal decontamination (SOD) are infection-prevention measures used in the treatment of some patients in intensive care, but reported effects on patient outcome are conflicting. METHODS: We evaluated the effectiveness of SDD and SOD in a crossover study using cluster randomization in 13 intensive care units (ICUs), all in The Netherlands. Patients with an expected duration of intubation of more than 48 hours or an expected ICU stay of more than 72 hours were eligible. In each ICU, three regimens (SDD, SOD, and standard care) were applied in random order over the course of 6 months. Mortality at day 28 was the primary end point. SDD consisted of 4 days of intravenous cefotaxime and topical application of tobramycin, colistin, and amphotericin B in the oropharynx and stomach. SOD consisted of oropharyngeal application only of the same antibiotics. Monthly point-prevalence studies were performed to analyze antibiotic resistance. RESULTS: A total of 5939 patients were enrolled in the study, with 1990 assigned to standard care, 1904 to SOD, and 2045 to SDD; crude mortality in the groups at day 28 was 27.5%, 26.6%, and 26.9%, respectively. In a random-effects logistic-regression model with age, sex, Acute Physiology and Chronic Health Evaluation (APACHE II) score, intubation status, and medical specialty used as covariates, odds ratios for death at day 28 in the SOD and SDD groups, as compared with the standard-care group, were 0.86 (95% confidence interval [CI], 0.74 to 0.99) and 0.83 (95% CI, 0.72 to 0.97), respectively. CONCLUSIONS: In an ICU population in which the mortality rate associated with standard care was 27.5% at day 28, the rate was reduced by an estimated 3.5 percentage points with SDD and by 2.9 percentage points with SOD. (Controlled Clinical Trials number, ISRCTN35176830.)