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SDD’s Rationale And Need For Mortality Trials
- Selective digestive decontamination (SDD) targets gram-negative aerobes and fungi while preserving anaerobic gut flora to prevent ICU infections.
- A mortality-focused randomized trial was needed because earlier SDD studies emphasized microbiologic endpoints rather than patient-centered outcomes.
Use Cluster Waiver Consent For Unit Policies
- Use waiver-of-consent cluster designs when an ICU-wide prophylactic policy must be tested and individual consent is impractical.
- Ensure unit leadership and infectious disease specialists agree to protocol and monitoring before implementation.
Cluster Crossover Design To Test Unit-Level Ecology
- The SuDDICU trial used a pragmatic cluster crossover design to apply SDD at unit level and measure hospital mortality.
- The trial enrolled mechanically ventilated patients, delivered topical oral and gastric non-absorbed antibiotics plus an IV 'SDD-compliant' antibiotic for early days, and predefined ecological monitoring.