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

Primary Purpose

Sleep Deprivation, Delirium

Status

Completed

Phase

Phase 4

Locations

International

Study Type

Interventional

Intervention

Dexmedetomidine

Placebo

About this trial

This is an interventional prevention trial for Sleep Deprivation focused on measuring sedation, sleep, delirium, critical illness, sub-syndromal delirium, intensive care

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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 Criteria:

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.

Sites / Locations

Tufts Medical Center
Maisonneuve Rosemont Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Dexmedetomidine

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

Development of delirium

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

Secondary Outcome Measures

Development of subsyndromal delirium

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

Full Information

NCT ID

NCT01791296

First Posted

February 12, 2013

Last Updated

March 15, 2017

Sponsor

Maisonneuve-Rosemont Hospital

Collaborators

Tufts Medical Center, Northeastern University

1. Study Identification

Unique Protocol Identification Number

NCT01791296

Brief Title

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

Acronym

SKY-DEX

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.

Study Type

Interventional

2. Study Status

Record Verification Date

March 2017

Overall Recruitment Status

Completed

Study Start Date

January 2011 (Actual)

Primary Completion Date

June 2016 (Actual)

Study Completion Date

December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Maisonneuve-Rosemont Hospital

Collaborators

Tufts Medical Center, Northeastern University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Specific Aims 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. Measure the safety and tolerance of adding night-time sedation with dexmedetomidine using adverse effects and withdrawal rates as indicators. 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.

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. To evaluate the impact of a dexmedetomidine-focussed nocturnal sleep protocol that minimizes arousal from sleep on: incidence of delirium [Intensive Care Delirium Screening Checklist (ICDSC) score ≥ 4] incidence of sub-syndromal delirium (ICDSC score 1-3) outcomes specifically defined by place of discharge from hospital (i.e., home,rehabilitation, or long-term care) To gain an understanding of the effect of night-time sedation with dexmedetomidine on: patient safety self-reported sleep quality 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] time spent within targeted sedation goal time spent without pain agitation-related events length of stay in the ICU duration of mechanical ventilation length of hospital stay 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: Hopital Maissonneuve Rosemont, Montreal, PQ Tufts Medical Center, Boston, MA

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Sleep Deprivation, Delirium

Keywords

sedation, sleep, delirium, critical illness, sub-syndromal delirium, intensive care

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Model Description

RCT

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Masking Description

Blinding for participants, care providers, investigator and outcomes assessor

Allocation

Randomized

Enrollment

100 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Dexmedetomidine

Arm Type

Experimental

Arm Description

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

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Dexmedetomidine

Other Intervention Name(s)

Precedex

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

Placebo

Other Intervention Name(s)

Normal Saline

Intervention Description

Primary Outcome Measure Information:

Title

Development of delirium

Description

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 Outcome Measure Information:

Title

Development of subsyndromal delirium

Description

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 Pre-specified Outcome Measures:

Title

Sleep quality

Description

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Criteria: 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yoanna Skrobik, MD

Organizational Affiliation

Université de Montréal

Official's Role

Principal Investigator

Facility Information:

Facility Name

Tufts Medical Center

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02111

Country

United States

Facility Name

Maisonneuve Rosemont Hospital

City

Montréal

State/Province

Quebec

ZIP/Postal Code

H1T 2M4

Country

Canada

12. IPD Sharing Statement

Citations:

PubMed Identifier

32847946

Citation

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.

Results Reference

derived

PubMed Identifier

29498534

Citation

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.

Results Reference

derived

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

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