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

• Status: Completed
• Trial end date: 2016-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Maisonneuve-Rosemont Hospital
• Collaborators: Northeastern University; Tufts Medical Center
• Treatments: Dexmedetomidine

Criteria

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.