drugset / Trial / NCT01791296

Does Nightly Dexmedetomidine Improve Sleep and Reduce Delirium in ICU Patients?

NCT01791296 ↗

RandomizedParallel-groupQuadruple-blindPrevention

Summary

Specific Aims 1. Establish the feasibility of larger trial by implementing a sleep protocol in the ICU at 2 different sites. Specifically will be estimating the recruitment rates of patients and the compliance with both interventions. 2. Measure the safety and tolerance of adding night-time sedation with dexmedetomidine using adverse effects and withdrawal rates as indicators. 3. Measure the effect of nocturnal dexmedetomidine on pertinent clinical outcomes and use this outcome data to plan a larger, multicenter trial in this area. The goal of this study is to determine whether a night-time protocol that incorporates a pharmacologic intervention associated with improved sleep (i.e. dexmedetomidine) will improve sleep quality and reduce the incidence of delirium and sub-syndromal delirium in critically ill patients.

Timeline

Start
2011-01
Primary completion
2016-06
Completion
2016-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Dexmedetomidine Other / unclassified 0.7 ug/kg Intravenous

Indications