NCT01791296

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

The Effect of a Dexmedetomidine-focussed Sleep Protocol* on Delirium Incidence and Healthcare Costs in Critically Ill Patients: A Prospective Randomized, Double-blind, Pilot Study.

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Maisonneuve-Rosemont Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The goal of this study is to determine whether a nocturnal 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 where ventilator settings have been optimized to optimize sleep quality. 1. To evaluate the impact of a dexmedetomidine-focussed nocturnal sleep protocol that minimizes arousal from sleep on: 1. incidence of delirium \[Intensive Care Delirium Screening Checklist (ICDSC) score ≥ 4\] 2. incidence of sub-syndromal delirium (ICDSC score 1-3) 3. outcomes specifically defined by place of discharge from hospital (i.e., home,rehabilitation, or long-term care) 2. To gain an understanding of the effect of night-time sedation with dexmedetomidine on: 1. patient safety 2. self-reported sleep quality 3. sleep quality and architecture \[based on a subgroup of 10 patients at Tufts Medical Center who will be evaluated using polysomnography(PSG) for one night\] 4. time spent within targeted sedation goal 5. time spent without pain 6. agitation-related events 7. length of stay in the ICU 8. duration of mechanical ventilation 9. length of hospital stay 10. total health care costs by measuring medication costs and hospitalization costs, as well as calculating effectiveness (sleep, sedation and pain management vs. cost). This multicenter study will be performed at: 1. Hopital Maissonneuve Rosemont, Montreal, PQ 2. Tufts Medical Center, Boston, MA

Conditions

• Sleep Deprivation
• Delirium

Interventions

Type	Name	Description
DRUG	Dexmedetomidine	At 21:30h, all current IV sedatives (whether continuous or intermittent) will be decreased by 50% and study drug started at 0.2 mcg/kg/hour at 21h30 to allow sleep between 22h00 and 6h00. Study infusion will be halved at 6:00am and d/c at 6:15am. The infusion rate will be increased by 0.1mcg/kg/hour every 15 minutes when the Riker-SAS is ≥ 4 up to a maximum rate of 0.7 mcg/kg/hr until the targeted sedation goal of a Riker-SAS of 3 is reached. For agitation (ie., Riker-SAS ≥ 5), 'as needed' IV midazolam (1-5 mg IV q1h prn agitation) may be administered during the upwards titration of the study medication. Administration of any dose of as needed IV midazolam will result in the increase of the study medication by 0.1 mcg/kg/hr when ≥ 15 minutes have elapsed since the last upwards titration.
OTHER	Placebo	At 21:30h, all current IV sedatives (whether continuous or intermittent) will be decreased by 50% and study drug started at 0.2 mcg/kg/hour at 21h30 to allow sleep between 22h00 and 6h00. Study infusion will be halved at 6:00am and d/c at 6:15am. The infusion rate will be increased by 0.1mcg/kg/hour every 15 minutes when the Riker-SAS is ≥ 4 up to a maximum rate of 0.7 mcg/kg/hr until the targeted sedation goal of a Riker-SAS of 3 is reached. For agitation (ie., Riker-SAS ≥ 5), 'as needed' IV midazolam (1-5 mg IV q1h prn agitation) may be administered during the upwards titration of the study medication. Administration of any dose of as needed IV midazolam will result in the increase of the study medication by 0.1 mcg/kg/hr when ≥ 15 minutes have elapsed since the last upwards titration.

Timeline

• Start date: 2011-01-01
• Primary completion: 2016-06-01
• Completion: 2016-12-01
• First posted: 2013-02-13
• Last updated: 2017-03-17

Locations

2 sites across 2 countries: United States, Canada