Status:
COMPLETED
Does Nightly Dexmedetomidine Improve Sleep and Reduce Delirium in ICU Patients?
Lead Sponsor:
Maisonneuve-Rosemont Hospital
Collaborating Sponsors:
Tufts Medical Center
Northeastern University
Conditions:
Sleep Deprivation
Delirium
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
Brief 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 ...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2016
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT01791296
Start Date
January 1 2011
End Date
December 1 2016
Last Update
March 17 2017
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Tufts Medical Center
Boston, Massachusetts, United States, 02111
2
Maisonneuve Rosemont Hospital
Montreal, Quebec, Canada, H1T 2M4