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Title: Effect of dexmedetomidine added to standard care on ventilator-free time in patients with agitated delirium: A randomized clinical trial
Authors: 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
Keywords: Ventilator Weaning
Treatment outcome
Time factors
Respiration, Artificial/statistics & numerical data*
Psychomotor Agitation/drug therapy*
Proportional Hazards Models
New Zealand
Hypnotics and Sedatives/administration & dosage*
Double-Blind method
Dexmedetomidine/administration & dosage*
Delirium/drug therapy*
Issue Date: 2016
Source: 315(14)
Abstract: IMPORTANCE: Effective therapy has not been established for patients with agitated delirium receiving mechanical ventilation. OBJECTIVE: To determine the effectiveness of dexmedetomidine when added to standard care in patients with agitated delirium receiving mechanical ventilation. DESIGN, SETTING, AND PARTICIPANTS: The Dexmedetomidine to Lessen ICU Agitation (DahLIA) study was a double-blind, placebo-controlled, parallel-group randomized clinical trial involving 74 adult patients in whom extubation was considered inappropriate because of the severity of agitation and delirium. The study was conducted at 15 intensive care units in Australia and New Zealand from May 2011 until December 2013. Patients with advanced dementia or traumatic brain injury were excluded. INTERVENTIONS: Bedside nursing staff administered dexmedetomidine (or placebo) initially at a rate of 0.5 µg/kg/h and then titrated to rates between 0 and 1.5 µg/kg/h to achieve physician-prescribed sedation goals. The study drug or placebo was continued until no longer required or up to 7 days. All other care was at the discretion of the treating physician. MAIN OUTCOMES AND MEASURES: Ventilator-free hours in the 7 days following randomization. There were 21 reported secondary outcomes that were defined a priori. RESULTS: Of the 74 randomized patients (median age, 57 years; 18 [24%] women), 2 withdrew consent later and 1 was found to have been randomized incorrectly, leaving 39 patients in the dexmedetomidine group and 32 patients in the placebo group for analysis. Dexmedetomidine increased ventilator-free hours at 7 days compared with placebo (median, 144.8 hours vs 127.5 hours, respectively; median difference between groups, 17.0 hours [95% CI, 4.0 to 33.2 hours]; P = .01). Among the 21 a priori secondary outcomes, none were significantly worse with dexmedetomidine, and several showed statistically significant benefit, including reduced time to extubation (median, 21.9 hours vs 44.3 hours with placebo; median difference between groups, 19.5 hours [95% CI, 5.3 to 31.1 hours]; P < .001) and accelerated resolution of delirium (median, 23.3 hours vs 40.0 hours; median difference between groups, 16.0 hours [95% CI, 3.0 to 28.0 hours]; P = .01). Using hierarchical Cox modeling to adjust for imbalanced baseline characteristics, allocation to dexmedetomidine was significantly associated with earlier extubation (hazard ratio, 0.47 [95% CI, 0.27-0.82]; P = .007). CONCLUSIONS AND RELEVANCE: Among patients with agitated delirium receiving mechanical ventilation in the intensive care unit, the addition of dexmedetomidine to standard care compared with standard care alone (placebo) resulted in more ventilator-free hours at 7 days. The findings support the use of dexmedetomidine in patients such as these.
DOI: 10.1001/jama.2016.2707
PubMed URL:
Journal Title: JAMA
Type: Journal Article
Affiliates: Burns, Trauma, and Critical Care Research Centre, University of Queensland and Joint Health Command, Australian Defence Force
Austin Hospital
School of Medicine, University of Melbourne and Austin Hospital
Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University
Flinders Medical Centre
Toowoomba Hospital
Peninsula Health
Royal North Shore Hospital of Sydney
Northern Hospital
Canberra Hospital
Royal Melbourne Hospital
Christchurch Hospital
Auckland City Hospital
Western Hospital
Royal Brisbane and Women's Hospital
Geelong Hospital
Wellington Hospital
Medical Research Institute of New Zealand
Study/Trial: Clinical Trial
Appears in Collections:Scholarly and Clinical

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