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Completed

NCT Number: NCT01151865

Dexmedetomidine to Lessen Intensive Care Unit (ICU) Agitation

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.

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Key information

Conditions

Delirium Confusion Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Royal North Shore Hospital, St Leonards, New South Wales, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dexmedetomidine

Drug

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 names: Precedex

Saline placebo

Drug

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.

Primary outcomes

  1. Ventilator-free hours

    Time frame: 7 days following randomisation

    The primary outcome measure for the study will be 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 normal saline placebo while receiving all other aspects of standard care.

Secondary outcomes

  1. Time to ICU discharge

    Time frame: On hospital discharge, or 6 months (whichever is sooner)

  2. Overall ICU length of stay

    Time frame: On hospital discharge, or 6 months (whichever is sooner)

  3. Time to first extubation

    Time frame: On hospital discharge, or 6 months (whichever is sooner)

  4. Time taken to achieve a satisfactory sedation score

    Time frame: 7 days following randomisation

    Time taken to achieve RASS score -2 to +1 and RIKER score 3 or 4

  5. %ICU time spent with a satisfactory sedation score

    Time frame: 7 days following randomisation

    %ICU time spent with RASS -2 to +1 and RIKER 3 or 4

  6. %ICU time spent with a satisfactory delirium score

    Time frame: 7 days following randomisation

    % time spent with a negative CAM-ICU assessment

  7. Time taken to achieve a satisfactory agitation score

    Time frame: 7 days following randomisation

    Time taken to achieve a MAAS score 2-4

  8. %ICU time spent with a satisfactory agitation score

    Time frame: 7 days following randomisation

    %ICU time spent with a MAAS score 2-4

  9. Need for supplementary sedative medication

    Time frame: 7 days following randomisation

    total infusion time, mean hourly dose and total dose of propofol, morphine and midazolam.

  10. Need for mechanical restraint

    Time frame: 7 days following randomisation

    Time to first not requiring restraint and % ICU time spent without mechanical restraint in the 7 days following commencement of trial medication

  11. Need for supplementary antipsychotic medication

    Time frame: 7 days following randomisation

    Number of doses and total mg delivered of haloperidol, olanzapine, quetiapine, or other anti-psychotic medication as prescribed by the treating physician

  12. Need for tracheostomy

    Time frame: On hospital discharge, or 6 months (whichever is sooner)

    Tracheostomy deemed to be necessary by the treating physician, and actually performed.

  13. Acute hospital length of stay

    Time frame: On hospital discharge, or 6 months (whichever is sooner)

    Total duration of admission to the acute hospital, prior to discharge to home or a skilled or unskilled nursing facility.

  14. Discharge destination

    Time frame: On hospital discharge, or 6 months (whichever is sooner)

    Discharge to home, a skilled nursing facility, residential care, a physical rehabilitation facility, or death.

  15. Daily SOFA score

    Time frame: 7 days following randomisation

    Daily SOFA score with recording of the component parts

  16. ICU mortality

    Time frame: On hospital discharge, or 6 months (whichever is sooner)

    ICU mortality

  17. Hospital mortality

    Time frame: On hospital discharge, or 6 months (whichever is sooner)

    Death in the acute care hospital

  18. Duration and rate of vasopressor support

    Time frame: 7 days following randomisation

    total infusion time, and mean hourly dose of noradrenaline and any other inotrope or vasopressor

  19. Need for insertion of a new central venous catheter to facilitate vasopressor / inotropic support

    Time frame: 7 days following randomisation

  20. Requirement for reintubation

    Time frame: On hospital discharge, or 6 months (whichever is sooner)

    Reintubation of the trachea to facilitate airway protection or mechanical ventilation, as indicated in the opinion of the treating physician

Sponsors and collaborators

Lead sponsor

Austin Health

Other Gov

Collaborators

  • Hospira, now a wholly owned subsidiary of Pfizer

Registry information

Official study title

A Randomised, Double-blind, Multi-centre Placebo Controlled Trial of Dexmedetomidine for Patients With Agitation and Delirium in the Intensive Care Unit

Acronym: DahLIA

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Jun 29, 2010
Registry last updated
Jan 21, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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