The use of selective antibiotic decontamination of the digestive tract compared to the use of live lactobacilli to prevent hospital acquired infections in Intensive Care patients.

In intensive care units (ICU's), hospital acquired infections are an important complication of the treatment. Such infections occur in around 45% of all ICU patients and are associated with increased mortality, a longer stay in the ICU and increased health care costs. Most of these infections are thought to be preceded by oropharyngeal and intestinal colonisation with potentially pathogenic micro-organisms. A method to prevent ICU acquired infections is the use of selective decontamination of the digestive tract (SDD). The purpose of SDD is to eliminate these potentially pathogenic micro-organisms from the digestive tract by using locally and systemically applied antibiotics without harming the anaerobic flora, ultimately resulting in less infections. The disadvantage of SDD is the selection of antibiotic resistant micro-organisms. Infections with these organisms in ICU patients usually are disastrous. At population level, selection of resistant micro-organisms ultimately leads to increased morbidity and mortality rates. Thus, a method with the beneficial effects of SDD without the risk of selection of antibiotic resistant micro-organisms would be ideal. Use of live lactobacilli plus fibre decreased hospital acquired infections in patients with abdominal surgery, liver transplantation and necrotic pancreatitis, but has not been applied in both medical and surgical ICU patients. This non-antibiotic method does not have the risk of selection of antibiotic resistance. In this study, we propose to compare the use of SDD with live lactobacilli plus fibre in a cross-over of units, randomized clinical trial, performed at the ICU of an university hospital. Patients will be randomized to receive either SDD or lactobacilli plus fibre until discharge from the ICU. Demographic data, indicators of severity of disease and follow up data will be collected in a standardised way. Surveillance cultures of sputum, throat swabs and rectal swabs will be taken on a regular basis. The primary endpoint is incidence of ICU acquired infections. Secondary endpoints are ICU and in-hospital mortality rates, selection of antibiotic resistant micro-organisms and additional use of antibiotics. Follow-up for selection of antibiotic resistant micro-organisms will be until death or 2 weeks after discharge from the ICU, for mortality until discharge from the hospital. Power analysis indicates that 250 patients per group must be included to prove equivalence in infection prevention of both regimes. Results of the study will be internationally conveyed to researchers and physicians by papers in international medical journals and presentations at conferences. Nationally, results will be made known, after a survey of use of SDD among ICU physicians, by sending results of the proposed study along with results of the survey to these same physicians.