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

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.

• To evaluate the impact of a dexmedetomidine-focussed nocturnal sleep protocol that minimizes arousal from sleep on:

• incidence of delirium [Intensive Care Delirium Screening Checklist (ICDSC) score ≥ 4]
• incidence of sub-syndromal delirium (ICDSC score 1-3)
• outcomes specifically defined by place of discharge from hospital (i.e., home,rehabilitation, or long-term care)
• To gain an understanding of the effect of night-time sedation with dexmedetomidine on:

• patient safety
• self-reported sleep quality
• 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]
• time spent within targeted sedation goal
• time spent without pain
• agitation-related events
• length of stay in the ICU
• duration of mechanical ventilation
• length of hospital stay
• 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:

• Hopital Maissonneuve Rosemont, Montreal, PQ
• Tufts Medical Center, Boston, MA

Inclusion criteria

• 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).

Exclusion criteria

• 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.