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CompletedNCT01791296SKY-DEXUpdated Mar 17, 2017

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

A Phase 4 interventional study of Dexmedetomidine and Placebo in Sleep Deprivation and Delirium, sponsored by Maisonneuve-Rosemont Hospital. Completed at 2 sites in 2 countries. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2017-03-17.

Sponsored by Maisonneuve-Rosemont Hospital · Phase 4, Interventional, and Prevention

From the registry’s dates

  • Registered 2 years 1 month after the study started (first participant enrolled Jan 2011, registered Feb 2013).
Phase
Phase 4
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

Read 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 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
02

Conditions studied

  • Sleep Deprivation
  • Delirium

Keywords

  • sedation
  • sleep
  • delirium
  • critical illness
  • sub-syndromal delirium
  • intensive care
03

In context

Delirium

1,057 studies on the registry are indexed under Delirium; 238 are open to participants now.

This study's enrollment of 100 is below the median of 120 across 599 interventional studies indexed under Delirium.

Browse Delirium studies →

Lead sponsor

Maisonneuve-Rosemont Hospital is the lead sponsor of 70 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.

05

Study design

Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
100 participants (actual)

Study arms

  • Experimental
    Dexmedetomidine

    Dexmedetomidine 0.2-0.7 mcg/kg/hr from 21:30 to 6:00

    Drug: Dexmedetomidine

  • Placebo comparator
    Placebo

    Normal Saline 0.2-0.7 mcg/kg/hr from 21:30 to 6:00

    Other: Placebo

Interventions

  • DrugDexmedetomidine

    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.

    Also known as: Precedex

  • OtherPlacebo

    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.

    Also known as: Normal Saline

06

What researchers measure

Primary outcomes

  1. Development of delirium

    Delirium will be assessed with the ICDSC (Intensive Care Delirium Screening CHecklist) q12h \[Delirium = ICDSC score \>/= 4\]

    Time frame: participants will be followed for the duration of their ICU stay, an expected average of 5-7 days

Secondary outcomes

  1. Development of subsyndromal delirium

    ICDSC measurement (routine in all participating units) q12h \[Subsyndromal delirium = ICDSC of 1-3\]

    Time frame: participants will be followed for the duration of ICU stay, an expected average of 5-7 days

Other outcomes

  1. Sleep quality

    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

    Time frame: participants will be followed for the duration of ICU stay, an expected average of 5-7 days

07

Study locations

2 sites
  • Tufts Medical Center
    Boston, Massachusetts 02111, United States
  • Maisonneuve Rosemont Hospital
    Montréal, Quebec H1T 2M4, Canada
08

References and documents

Publications

  • Duprey MS, Devlin JW, Skrobik Y. Is there an association between subjective sleep quality and daily delirium occurrence in critically ill adults? A post hoc analysis of a randomised controlled trial. BMJ Open Respir Res. 2020 Aug;7(1):e000576. doi: 10.1136/bmjresp-2020-000576. PubMed 32847946 ↗
  • Skrobik Y, Duprey MS, Hill NS, Devlin JW. Low-Dose Nocturnal Dexmedetomidine Prevents ICU Delirium. A Randomized, Placebo-controlled Trial. Am J Respir Crit Care Med. 2018 May 1;197(9):1147-1156. doi: 10.1164/rccm.201710-1995OC. PubMed 29498534 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 17, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01791296
Lead sponsor
Maisonneuve-Rosemont Hospital
Collaborators
Tufts Medical Center, Northeastern University
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) — Principal investigator
First posted
Feb 13, 2013
Start date
Jan 2011
Primary completion
Jun 2016
Completion
Dec 2016
Last update
Mar 17, 2017

Study contacts

Yoanna Skrobik, MD
principal investigator · Université de Montréal

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2017. You cannot join it, but the record below documents what was studied.

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