Dexmedetomidine to Lessen Intensive Care Unit (ICU) Agitation

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.

Conditions

• Delirium

Interventions

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.

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.

Sponsors & Collaborators

• Hospira, now a wholly owned subsidiary of Pfizer

  collaborator INDUSTRY

• Austin Health

  lead OTHER_GOV

Principal Investigators

• Michael C Reade, MBBS DPhil · Austin Hospital & University of Melbourne

• Rinaldo Bellomo, MD · Austin Hospital and University of Melbourne

• John Mulder, MBChB · Western Hospital, Melbourne

• Ben Cheung, MBBS · Toowoomba Hospital

• Anthony Delaney, MBBS · Royal North Shore Hospital

• Andrew Davis, MBBS · The Alfred

• Steve Webb, MBBS · Royal Perth Hospital

• Michael Bailey, MSc PhD · Monash University

• Glenn Eastwood, BNurs RN · Austin Hospital, Melbourne Australia

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2011-02-28

Primary Completion

2013-12-31

Completion

2013-12-31

Countries

• Australia

Study Locations