Does Nightly Dexmedetomidine Improve Sleep and Reduce Delirium in ICU Patients? (SKY-DEX)

This study is currently recruiting participants.
Verified February 2013 by Maisonneuve-Rosemont Hospital
Sponsor:
Collaborators:
Tufts Medical Center
Northeastern University
Information provided by (Responsible Party):
Yoanna Skrobik, Maisonneuve-Rosemont Hospital
ClinicalTrials.gov Identifier:
NCT01791296
First received: February 12, 2013
Last updated: February 13, 2013
Last verified: February 2013
  Purpose

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.


Condition Intervention Phase
Sleep Deprivation
Delirium
Drug: Dexmedetomidine
Other: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Effect of a Dexmedetomidine-focussed Sleep Protocol* on Delirium Incidence and Healthcare Costs in Critically Ill Patients: A Prospective Randomized, Double-blind, Pilot Study.

Resource links provided by NLM:


Further study details as provided by Maisonneuve-Rosemont Hospital:

Primary Outcome Measures:
  • Development of delirium [ Time Frame: participants will be followed for the duration of their ICU stay, an expected average of 5-7 days ] [ Designated as safety issue: No ]
    Delirium will be assessed with the ICDSC (Intensive Care Delirium Screening CHecklist) q12h [Delirium = ICDSC score >/= 4]


Secondary Outcome Measures:
  • Development of subsyndromal delirium [ Time Frame: participants will be followed for the duration of ICU stay, an expected average of 5-7 days ] [ Designated as safety issue: No ]
    ICDSC measurement (routine in all participating units) q12h [Subsyndromal delirium = ICDSC of 1-3]


Other Outcome Measures:
  • Sleep quality [ Time Frame: participants will be followed for the duration of ICU stay, an expected average of 5-7 days ] [ Designated as safety issue: No ]
    Sleep quality will be assessed with a validated sleep questionnaire and polysomnography (PSG) evaluation in a subset of 10 patients at Tufts Med Center site


Estimated Enrollment: 100
Study Start Date: January 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dexmedetomidine
Dexmedetomidine 0.2-0.7 mcg/kg/hr from 21:30 to 6:00
Drug: Dexmedetomidine
At 21:30h, all current IV sedatives (whether continuous or intermittent) will be decreased by 50% and study drug started at 0.2 mcg/kg/hour at 21h30 to allow sleep between 22h00 and 6h00. Study infusion will be halved at 6:00am and d/c at 6:15am. The infusion rate will be increased by 0.1mcg/kg/hour every 15 minutes when the Riker-SAS is ≥ 4 up to a maximum rate of 0.7 mcg/kg/hr until the targeted sedation goal of a Riker-SAS of 3 is reached. For agitation (ie., Riker-SAS ≥ 5), 'as needed' IV midazolam (1-5 mg IV q1h prn agitation) may be administered during the upwards titration of the study medication. Administration of any dose of as needed IV midazolam will result in the increase of the study medication by 0.1 mcg/kg/hr when ≥ 15 minutes have elapsed since the last upwards titration.
Other Name: Precedex
Placebo Comparator: Placebo
Normal Saline 0.2-0.7 mcg/kg/hr from 21:30 to 6:00
Other: Placebo
At 21:30h, all current IV sedatives (whether continuous or intermittent) will be decreased by 50% and study drug started at 0.2 mcg/kg/hour at 21h30 to allow sleep between 22h00 and 6h00. Study infusion will be halved at 6:00am and d/c at 6:15am. The infusion rate will be increased by 0.1mcg/kg/hour every 15 minutes when the Riker-SAS is ≥ 4 up to a maximum rate of 0.7 mcg/kg/hr until the targeted sedation goal of a Riker-SAS of 3 is reached. For agitation (ie., Riker-SAS ≥ 5), 'as needed' IV midazolam (1-5 mg IV q1h prn agitation) may be administered during the upwards titration of the study medication. Administration of any dose of as needed IV midazolam will result in the increase of the study medication by 0.1 mcg/kg/hr when ≥ 15 minutes have elapsed since the last upwards titration.
Other Name: Normal Saline

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 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
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01791296

Contacts
Contact: Yoanna Skrobik, MD 514 252-3400 skrobik@sympatico.ca
Contact: Johanne Harvey, RN 514 252-3400 jharvey.hmr@ssss.gouv.qc.ca

Locations
United States, Massachusetts
Tufts Medical Center Active, not recruiting
Boston, Massachusetts, United States, 02111
Canada, Quebec
Maisonneuve Rosemont Hospital Recruiting
Montréal, Quebec, Canada, H1T 2M4
Contact: Yoanna Skrobik, MD FRCP(c)    1-514-252-3400 ext 6229    yoanna.skrobik@umontreal.ca   
Contact: Johanna Harvey, RN    1-514-252-3400 ext 4679    jharvey.hmr@ssss.gouv.qc.ca   
Sponsors and Collaborators
Maisonneuve-Rosemont Hospital
Tufts Medical Center
Northeastern University
Investigators
Principal Investigator: Yoanna Skrobik, MD Université de Montréal
  More Information

No publications provided

Responsible Party: Yoanna Skrobik, Yoanna Skrobik MD FRCP(c), Professor of Medicine, University of Montreal; Lise and Jean Saine critical care chair, Maisonneuve-Rosemont Hospital
ClinicalTrials.gov Identifier: NCT01791296     History of Changes
Other Study ID Numbers: 10053
Study First Received: February 12, 2013
Last Updated: February 13, 2013
Health Authority: Canada: Ethics Review Committee
United States: Institutional Review Board (Tufts Med Center)

Keywords provided by Maisonneuve-Rosemont Hospital:
sedation
sleep
delirium
critical illness
sub-syndromal delirium
intensive care

Additional relevant MeSH terms:
Delirium
Delirium, Dementia, Amnestic, Cognitive Disorders
Sleep Deprivation
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Mental Disorders
Dyssomnias
Sleep Disorders
Dexmedetomidine
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 23, 2014