Dexmedetomidine to Lessen Intensive Care Unit (ICU) Agitation

Austin Health96 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Delirium

Interventions

DexmedetomidineDRUG

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.

Saline placeboDRUG

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (7)

Royal North Shore Hospital

St Leonards, New South Wales, Australia

Toowoomba Hospital

Toowoomba, Queensland, Australia

Northern Hospital

Epping, Victoria, Australia

The Western Hospital

Footscray, Victoria, Australia

Outcomes

Primary Outcomes

Ventilator-free hours

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.

Time frame: 7 days following randomisation

Secondary Outcomes

Time to ICU discharge

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

Overall ICU length of stay

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

Time to first extubation

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

Time taken to achieve a satisfactory sedation score

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

Time frame: 7 days following randomisation

%ICU time spent with a satisfactory sedation score

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

Time frame: 7 days following randomisation

%ICU time spent with a satisfactory delirium score

% time spent with a negative CAM-ICU assessment

Time frame: 7 days following randomisation

Time taken to achieve a satisfactory agitation score

Time taken to achieve a MAAS score 2-4

Time frame: 7 days following randomisation

Data from ClinicalTrials.gov

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