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.

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

Inclusion Criteria:

1. Age ≥ 18 years

2. Current expectation on the part of the patient's admitting intensivist for patients
to require ICU care for >/= 48 hrs

3. Administered at least one sedative dose (scheduled or prn).

Exclusion Criteria:

1. Patients with delirium (intensive care delirium screening checklist score ≥ 4) or
disorientation (not oriented to person and/or place)

2. Patients in whom an ICDSC cannot be reliably completed (e.g. primary language is not
French or English, baseline severe hearing impairment)

3. Inability by one of the investigators to obtain informed consent from the legally
authorized representative

4. Treating physician refusal

5. Heart rate ≤ 50 BPM

6. Systolic blood pressure ≤ 90 mmHg despite the administration of norepinephrine ≥ 15
mcg/min and/or vasopressin ≥ 0.04 units/min

7. Admission with acute decompensated heart failure

8. History of heart block without pacemaker based on hospital admission note.

9. Acute alcohol withdrawal based on hospital admission note

10. 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)

11. Irreversible brain disease consistent with severe dementia based on hospital
admission note

12. Pregnancy (all women of child-bearing age will undergo a pregnancy test prior to
study enrolment)

13. Known allergy or sensitivity to clonidine or dexmedetomidine

14. 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.