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

Completed · Phase 4 · Has a placebo group

Conditions studied: Sleep Deprivation, Delirium

In brief

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.

Key facts

Study ID

NCT01791296

Run by

Maisonneuve-Rosemont Hospital

People needed

100

Starts

2011-01-01

Expected to finish

2016-12-01

Last updated by the study team

2017-03-17

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age ≥ 18 years
• Current expectation on the part of the patient's admitting intensivist for patients to require ICU care for >/= 48 hrs
• Administered at least one sedative dose (scheduled or prn).

You may not qualify if…

• Patients with delirium (intensive care delirium screening checklist score ≥ 4) or disorientation (not oriented to person and/or place)
• Patients in whom an ICDSC cannot be reliably completed (e.g. primary language is not French or English, baseline severe hearing impairment)
• Inability by one of the investigators to obtain informed consent from the legally authorized representative
• Treating physician refusal
• Heart rate ≤ 50 BPM
• Systolic blood pressure ≤ 90 mmHg despite the administration of norepinephrine ≥ 15 mcg/min and/or vasopressin ≥ 0.04 units/min
• Admission with acute decompensated heart failure
• History of heart block without pacemaker based on hospital admission note.
• Acute alcohol withdrawal based on hospital admission note
• History of end stage liver failure (based on presence of ≥ 1 or more of the following: AST/ALT ≥ 2 times ULN, INR ≥ 2, total bilirubin ≥ 1.5)
• Irreversible brain disease consistent with severe dementia based on hospital admission note
• Pregnancy (all women of child-bearing age will undergo a pregnancy test prior to study enrolment)
• Known allergy or sensitivity to clonidine or dexmedetomidine
• Current treatment with dexmedetomidine
• p. Prognosis considered to be hopeless based on consultation with the ICU admitting physician q. Age ≥80 years r. Currently being managed with a high frequency oscillating mode (HFOV) of mechanical ventilation.

Where it is running

• Tufts Medical Center — Boston, Massachusetts, United States
• Maisonneuve Rosemont Hospital — Montreal, Quebec, Canada

Full record on ClinicalTrials.gov

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