Please use this identifier to cite or link to this item: https://ahro.austin.org.au/austinjspui/handle/1/16535
Title: Effect of dexmedetomidine added to standard care on ventilator-free time in patients with agitated delirium: a randomized clinical trial
Austin Authors: Reade, Michael C;Eastwood, Glenn M ;Bellomo, Rinaldo ;Bailey, Michael;Bersten, Andrew;Cheung, Benjamin;Davies, Andrew;Delaney, Anthony;Ghosh, Angaj;van Haren, Frank;Harley, Nerina;Knight, David;McGuiness, Shay;Mulder, John;O’Donoghue, Steve;Simpson, Nicholas;Young, Paul;DahLIA Investigators;Australian and New Zealand Intensive Care Society Clinical Trials Group
Affiliation: Burns, Trauma, and Critical Care Research Centre, University of Queensland, Brisbane, Queensland, Australia
Joint Health Command, Australian Defence Force, Brisbane, Queensland, Australia
Austin Health, Heidelberg, Victoria, Australia
School of Medicine, University of Melbourne, Melbourne, Victoria, Australia
Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, Australia
Flinders Medical Centre, Adelaide, South Australia, Australia
Toowoomba Hospital, Toowoomba, Queensland, Australia
Peninsula Health, Melbourne, Victoria, Australia
Royal North Shore Hospital of Sydney, Sydney, NSW, Australia
Northern Hospital, Melbourne, Victoria, Australia
Canberra Hospital, Canberra, ACT, Australia
Royal Melbourne Hospital, Melbourne, Victoria, Australia
Christchurch Hospital, Christchurch, New Zealand
Auckland City Hospital, Auckland, New Zealand
Western Hospital, Melbourne, Victoria, Australia
Royal Brisbane and Women’s Hospital, Brisbane, Queensland, Australia
Geelong Hospital, Geelong, Victoria, Australia
Wellington Hospital, Wellington, New Zealand
Medical Research Institute of New Zealand, Wellington
Issue Date: 12-Apr-2016
Publication information: JAMA 2016; 315(14): 1460-1468
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. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01151865.
Description: Erratum in: Expanded Explanation of the Sample Size Calculation. JAMA 2016; 316(7): 775. doi: 10.1001/jama.2016.9458.
URI: http://ahro.austin.org.au/austinjspui/handle/1/16535
DOI: 10.1001/jama.2016.2707
ORCID: 0000-0002-1650-8939
PubMed URL: https://pubmed.ncbi.nlm.nih.gov/26975647
Type: Journal Article
Subjects: Delerium
Hypnotics and sedatives
Dexmedetomidine
Psychomotor Agitation
Respiration
Appears in Collections:Journal articles

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