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Effect of Acetazolamide vs Placebo on Duration of Invasive Mechanical Ventilation Among Patients With Chronic Obstructive Pulmonary Disease: A Randomized Clinical Trial.
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- Author(s): Faisy, Christophe; Meziani, Ferhat; Planquette, Benjamin; Clavel, Marc; Gacouin, Arnaud; Bornstain, Caroline; Schneider, Francis; Duguet, Alexandre; Gibot, Sébastien; Lerolle, Nicolas; Ricard, Jean-Damien; Sanchez, Olivier; Djibre, Michel; Ricome, Jean-Louis; Rabbat, Antoine; Heming, Nicholas; Urien, Saïk; Esvan, Maxime; Katsahian, Sandrine; DIABOLO Investigators
- Source:
JAMA: Journal of the American Medical Association; 2/2/2016, Vol. 315 Issue 5, p480-488, 9p- Subject Terms:
OBSTRUCTIVE lung disease treatment; ACETAZOLAMIDE; ARTIFICIAL respiration; BICARBONATE ions; CARBON dioxide; CLINICAL trials; COMPARATIVE studies; OBSTRUCTIVE lung diseases; RESEARCH methodology; MEDICAL cooperation; RESEARCH; TIME; MECHANICAL ventilators; EVALUATION research; RANDOMIZED controlled trials; TREATMENT effectiveness; BLIND experiment; CARBONIC anhydrase inhibitors; RESPIRATORY alkalosis; THERAPEUTICS - Source:
- Additional Information
- Abstract:
Importance: Acetazolamide has been used for decades as a respiratory stimulant for patients with chronic obstructive pulmonary disease (COPD) and metabolic alkalosis, but no large randomized placebo-controlled trial is available to confirm this approach.Objective: To determine whether acetazolamide reduces mechanical ventilation duration in critically ill patients with COPD and metabolic alkalosis.Design, Setting, and Participants: The DIABOLO study, a randomized, double-blind, multicenter trial, was conducted from October 2011 through July 2014 in 15 intensive care units (ICUs) in France. A total of 382 patients with COPD who were expected to receive mechanical ventilation for more 24 hours were randomized to the acetazolamide or placebo group and 380 were included in an intention-to treat analysis.Interventions: Acetazolamide (500-1000 mg, twice daily) vs placebo administered intravenously in cases of pure or mixed metabolic alkalosis, initiated within 48 hours of ICU admission and continued during the ICU stay for a maximum of 28 days.Main Outcomes and Measures: The primary outcome was the duration of invasive mechanical ventilation via endotracheal intubation or tracheotomy. Secondary outcomes included changes in arterial blood gas and respiratory parameters, weaning duration, adverse events, use of noninvasive ventilation after extubation, successful weaning, the duration of ICU stay, and in-ICU mortality.Results: Among 382 randomized patients, 380 (mean age, 69 years; 272 men [71.6%]; 379 [99.7%] with endotracheal intubation) completed the study. For the acetazolamide group (n = 187), compared with the placebo group (n = 193), no significant between-group differences were found for median duration of mechanical ventilation (-16.0 hours; 95% CI, -36.5 to 4.0 hours; P = .17), duration of weaning off mechanical ventilation (-0.9 hours; 95% CI, -4.3 to 1.3 hours; P = .36), daily changes of minute-ventilation (-0.0 L/min; 95% CI, -0.2 to 0.2 L/min; P = .72), or partial carbon-dioxide pressure in arterial blood (-0.3 mm Hg; 95% CI, -0.8 to 0.2 mm Hg; P = .25), although daily changes of serum bicarbonate (between-group difference, -0.8 mEq/L; 95% CI, -1.2 to -0.5 mEq/L; P < .001) and number of days with metabolic alkalosis (between-group difference, -1; 95% CI, -2 to -1 days; P < .001) decreased significantly more in the acetazolamide group. Other secondary outcomes also did not differ significantly between groups.Conclusions and Relevance: Among patients with COPD receiving invasive mechanical ventilation, the use of acetazolamide, compared with placebo, did not result in a statistically significant reduction in the duration of invasive mechanical ventilation. However, the magnitude of the difference was clinically important, and it is possible that the study was underpowered to establish statistical significance.Trial Registration: clinicaltrials.gov Identifier: NCT01627639. [ABSTRACT FROM AUTHOR] - Abstract: Copyright of JAMA: Journal of the American Medical Association is the property of American Medical Association and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)
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