Selective Digestive Decontamination Fails to Reduce In-Hospital Mortality in Ventilated ICU Patients: NEJM
Australia: Researchers have found in an international trial of over 9,000 mechanically ventilated ICU patients that selective decontamination of the digestive tract (SDD) did not significantly reduce in-hospital mortality compared to standard care (27.9% vs 29.5%). However, secondary analyses revealed fewer new bloodstream infections among patients receiving SDD.
The study, published in The New England Journal of Medicine and conducted by The SuDDICU Investigators for the Australia and New Zealand Intensive Care Society Clinical Trials Group and the Canadian Critical Care Trials Group, aimed to determine whether SDD could lower mortality and prevent microbial resistance in critically ill patients.
The trial was carried out across 26 intensive care units (ICUs) in Australia and Canada, involving a total of 20,000 patients, of whom 9,289 were enrolled in the randomized comparison and 10,711 were included in an ecological assessment. The ICUs were randomly assigned to either implement the SDD protocol or continue standard care for two consecutive 12-month periods.
In the SDD group, patients received oral and gastric antibiotics throughout the duration of mechanical ventilation, along with intravenous antibiotics for the first four days after enrollment. The primary endpoint of the study was all-cause in-hospital mortality at 90 days. Secondary outcomes included ICU mortality, ventilator-free days, and the incidence of new bloodstream infections and antibiotic-resistant organisms.
Key Findings:
- At 90 days, mortality rates were nearly identical between the two groups—27.9% in the SDD group and 29.5% in the standard care group (OR 0.93), indicating no significant mortality reduction with SDD.
- The incidence of new bloodstream infections was lower among patients who received SDD (4.9%) compared to those given standard care (6.8%), with an adjusted mean difference of −1.30 percentage points.
- Antibiotic-resistant organisms were cultured in 16.8% of the SDD group versus 26.8% in the standard-care group, showing a notable decrease in resistant bacterial colonization (adjusted mean difference, −9.60 percentage points).
- In the ecological assessment, the noninferiority of SDD for the emergence of new antibiotic-resistant organisms could not be confirmed, suggesting the need for continued monitoring of resistance patterns.
- Adverse events considered related to SDD or standard care were rare—reported in only 0.3% of SDD patients and none in the standard-care group.
- Serious adverse events occurred at similar rates between the two groups, affecting 1.1% of patients in the SDD group and 1.2% in the standard-care group.
"The large-scale, multicountry trial demonstrated that SDD did not significantly improve survival among critically ill, mechanically ventilated patients, despite reducing bloodstream infections and resistant organism colonization. The findings highlight the need for continued evaluation of infection prevention strategies that balance patient safety with antimicrobial stewardship in the ICU setting," the authors concluded.
Reference:
SuDDICU Investigators for the Australia and New Zealand Intensive Care Society Clinical Trials Group and the Canadian Critical Care Trials Group; Cuthbertson BH, Billot L, Campbell MK, Daneman N, Davis JS, Delaney A, Devaux A, Ferguson ND, Finfer SR, Fowler R, Gordon AC, Hammond NE, Klein G, Li Q, Marshall J, Micallef S, Murthy S, Mysore J, Naik C, Patel C, Pinto R, Rose L, Seppelt IM, Venkatesh B, Young PJ, Myburgh JA. Selective Decontamination of the Digestive Tract during Ventilation in the ICU. N Engl J Med. 2025 Oct 29. doi: 10.1056/NEJMoa2506398. Epub ahead of print. PMID: 41159880.
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