Dexmedetomidine to Lessen Intensive Care Unit (ICU) Agitation

NCT01151865

Last updated date
Study Location
Royal North Shore Hospital
St Leonards, New South Wales, 2065, Australia
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Delirium
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

Patients will be eligible for the study if, in the opinion of the treating clinician, they continue to require mechanical ventilation only because their degree of agitation requires such a high dose of sedative medication (midazolam or propofol, the only commonly used specific sedatives in our unit) that extubation is not possible, AND in the opinion of their treating intensivist their agitation is so severe as to make lessening their sedation unsafe.

These criteria will be objectively quantified as follows:

- they have required either mechanical restraint and/or anti-delirium or sedative medication in the 4 hours prior to seeking consent AND

- their Confusion Assessment Method for the ICU (CAM-ICU) test is positive for delirium in the 4 hours prior to seeking consent AND

- their Motor Activity Assessment Scale (MAAS) score is 5 or more in the 4 hours prior to seeking consent, confirming psychomotor agitation AND

- their SOFA score is less than or equal to 5 in the 4 hours prior to seeking consent, predicting a mortality or around 5%.

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Age less than 18 years old


- Pregnancy or breastfeeding


- Advanced dementia (in the premorbid state requiring professional nursing care)


- Open or closed head injury


- Death is deemed imminent and inevitable


- The patient has previously been enrolled in the DahLIA study


- Patients who could not be extubated, or who would be intubated within the following 48
hours, even if delirium or agitation were corrected. This will include:


- Patients receiving high dose opioid for analgesia (not sedation) ( > 40
mg/morphine/day)


- Patients shortly to return to the operating theatre


- Patients undergoing repeated invasive procedures, in whom it is desirable to
maintain deep sedation


- Patients likely to require ongoing airway protection or control, or ventilatory
support (for example, spinal patients with an inadequate vital capacity)


- Known allergy to haloperidol or alpha 2 agonists

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DeliriumDexmedetomidine to Lessen Intensive Care Unit (ICU) Agitation
NCT01151865
  1. St Leonards, New South Wales
  2. Toowoomba, Queensland
  3. Epping, Victoria
  4. Footscray, Victoria
  5. Melbourne, Victoria
  6. Prahran, Victoria
  7. Perth, Western Australia
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Dexmedetomidine to Lessen Intensive Care Unit (ICU) Agitation
Official Title  ICMJE A Randomised, Double-blind, Multi-centre Placebo Controlled Trial of Dexmedetomidine for Patients With Agitation and Delirium in the Intensive Care Unit
Brief Summary

The primary aim of the DahLIA trial is to determine, in patients with ICU-associated delirium and agitation who are otherwise pathophysiologically stable (as defined), the number of ventilator-free hours in the incident ICU admission in the 7 days following commencement of trial medication, in patients randomised to receive dexmedetomidine or placebo while receiving all other aspects of standard care.

The null hypothesis assumes no difference in the median number of ventilator-free hours in this ICU admission in the following 7 days, between patients receiving dexmedetomidine and placebo for ICU-associated agitation and delirium.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Delirium
Intervention  ICMJE
  • Drug: Dexmedetomidine

    Dexmedetomidine will be administered intravenously as a maintenance infusion of 0.2 to 1.5 mcg/kg/hour, commencing at 0.5 mcg/kg/hour and titrated according to effect, for as long as deemed necessary by the treating physician. Specifically, the study medication may be (as recommended by the manufacturer) continued after extubation, and if discontinued may be restarted at any time up until ICU discharge. The clinician will have the option of using a loading dose of 1.0 mcg/kg IV over 20 minutes, as recommended by the manufacturer.

    Bedside nursing staff will adjust drug infusion rates as necessary, in consultation with the treating physician, aiming to achieve a Riker Sedation-Agitation Scale 20 score of 4.

    Other Name: Precedex
  • Drug: Saline placebo
    An identical syringe containing only saline with no dexmedetomidine added will be supplied. Initial rate of infusion and subsequent adjustments will be the same as in the active comparator group.
Study Arms  ICMJE
  • Active Comparator: Dexmedetomidine

    Dexmedetomidine will be administered intravenously as a maintenance infusion of 0.2 to 1.5 mcg/kg/hour, commencing at 0.5 mcg/kg/hour and titrated according to effect, for as long as deemed necessary by the treating physician. Specifically, the study medication may be (as recommended by the manufacturer) continued after extubation, and if discontinued may be restarted at any time up until ICU discharge. The clinician will have the option of using a loading dose of 1.0 mcg/kg IV over 20 minutes, as recommended by the manufacturer.

    Bedside nursing staff will adjust drug infusion rates as necessary, in consultation with the treating physician, aiming to achieve a Riker Sedation-Agitation Scale 20 score of 4.

    Intervention: Drug: Dexmedetomidine
  • Placebo Comparator: Saline placebo
    An identical syringe to that in the intervention arm, but which does not contain dexmedetomidine, will be provided. The initial rate of infusion and subsequent adjustments will be the same as in the dexmedetomidine group.
    Intervention: Drug: Saline placebo
Publications * Reade MC, Eastwood GM, Bellomo R, Bailey M, Bersten A, Cheung B, Davies A, Delaney A, Ghosh A, van Haren F, Harley N, Knight D, McGuiness S, Mulder J, O'Donoghue S, Simpson N, Young P; DahLIA Investigators; Australian and New Zealand Intensive Care Society Clinical Trials Group. Effect of Dexmedetomidine Added to Standard Care on Ventilator-Free Time in Patients With Agitated Delirium: A Randomized Clinical Trial. JAMA. 2016 Apr 12;315(14):1460-8. doi: 10.1001/jama.2016.2707. Erratum in: JAMA. 2016 Aug 16;316(7):775.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 28, 2010)
96
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2013
Actual Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

Patients will be eligible for the study if, in the opinion of the treating clinician, they continue to require mechanical ventilation only because their degree of agitation requires such a high dose of sedative medication (midazolam or propofol, the only commonly used specific sedatives in our unit) that extubation is not possible, AND in the opinion of their treating intensivist their agitation is so severe as to make lessening their sedation unsafe.

These criteria will be objectively quantified as follows:

  • they have required either mechanical restraint and/or anti-delirium or sedative medication in the 4 hours prior to seeking consent AND
  • their Confusion Assessment Method for the ICU (CAM-ICU) test is positive for delirium in the 4 hours prior to seeking consent AND
  • their Motor Activity Assessment Scale (MAAS) score is 5 or more in the 4 hours prior to seeking consent, confirming psychomotor agitation AND
  • their SOFA score is less than or equal to 5 in the 4 hours prior to seeking consent, predicting a mortality or around 5%.

Exclusion Criteria:

  • Age less than 18 years old
  • Pregnancy or breastfeeding
  • Advanced dementia (in the premorbid state requiring professional nursing care)
  • Open or closed head injury
  • Death is deemed imminent and inevitable
  • The patient has previously been enrolled in the DahLIA study
  • Patients who could not be extubated, or who would be intubated within the following 48 hours, even if delirium or agitation were corrected. This will include:

    • Patients receiving high dose opioid for analgesia (not sedation) ( > 40 mg/morphine/day)
    • Patients shortly to return to the operating theatre
    • Patients undergoing repeated invasive procedures, in whom it is desirable to maintain deep sedation
    • Patients likely to require ongoing airway protection or control, or ventilatory support (for example, spinal patients with an inadequate vital capacity)
  • Known allergy to haloperidol or alpha 2 agonists
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01151865
Other Study ID Numbers  ICMJE H2010/03891
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party GLENN EASTWOOD, Austin Health
Study Sponsor  ICMJE Austin Health
Collaborators  ICMJE Hospira, now a wholly owned subsidiary of Pfizer
Investigators  ICMJE
Study Chair:Michael C Reade, MBBS DPhilAustin Hospital & University of Melbourne
Principal Investigator:Rinaldo Bellomo, MDAustin Hospital and University of Melbourne
Principal Investigator:John Mulder, MBChBWestern Hospital, Melbourne
Principal Investigator:Ben Cheung, MBBSToowoomba Hospital
Principal Investigator:Anthony Delaney, MBBSRoyal North Shore Hospital
Principal Investigator:Andrew Davis, MBBSThe Alfred
Principal Investigator:Steve Webb, MBBSRoyal Perth Hospital
Principal Investigator:Michael Bailey, MSc PhDMonash University
Principal Investigator:Glenn Eastwood, BNurs RNAustin Hospital, Melbourne Australia
PRS Account Austin Health
Verification Date January 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP