Effect of acetazolamide vs placebo on duration of invasive mechanical ventilation among patients with chronic obstructive pulmonary disease: A randomized clinical trial
| Autor: | Jean-Louis Ricome, Alexandre Duguet, Maxime Esvan, Christophe Faisy, Caroline Bornstain, Nicolas Lerolle, Saik Urien, Francis Schneider, Ferhat Meziani, Olivier Sanchez, Nicholas Heming, Antoine Rabbat, Michel Djibré, Sébastien Gibot, Benjamin Planquette, Marc Clavel, Arnaud Gacouin, Sandrine Katsahian, Jean-Damien Ricard |
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| Přispěvatelé: | Hôpital Européen Georges Pompidou [APHP] ( HEGP ), CHU Strasbourg, Stress vasculaire et tissulaire en transplantation : microparticules et environnement, Université de Strasbourg ( UNISTRA ), Hôpital André Mignot, CHU Limoges, CHU Pontchaillou [Rennes], Groupe Hospitalier Intercommunal Le Raincy-Montfermeil, Hôpital de Hautepierre [Strasbourg], Service de Pneumologie – Réanimation Médicale, CHU Pitié-Salpêtrière [APHP]-Assistance publique - Hôpitaux de Paris (AP-HP)-Université Pierre et Marie Curie - Paris 6 ( UPMC ), Défaillance Cardiovasculaire Aiguë et Chronique ( DCAC ), Centre Hospitalier Régional Universitaire de Nancy ( CHRU Nancy ) -Institut National de la Santé et de la Recherche Médicale ( INSERM ) -Université de Lorraine ( UL ), Service de Soins Intensifs [CHRU Nancy], Centre Hospitalier Régional Universitaire de Nancy ( CHRU Nancy ), Service de Soins Intensifs [Angers], CHU Angers, Service des soins intensifs [Hôpital Louis Mourier], Hopital Louis Mourier - AP-HP [Colombes], Service des soins intensifs [CHU Tenon], Assistance publique - Hôpitaux de Paris (AP-HP)-CHU Tenon [APHP], CHI Poissy-Saint-Germain, Unité de Soins Intensifs [CHU Cochin], CHU Cochin [AP-HP]-Assistance publique - Hôpitaux de Paris (AP-HP), Hôpital Européen Georges Pompidou [APHP] (HEGP), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpitaux Universitaires Paris Ouest - Hôpitaux Universitaires Île de France Ouest (HUPO), Université de Strasbourg (UNISTRA), Centre Hospitalier de Versailles André Mignot (CHV), Service de Pneumologie – Réanimation Médicale [CHU Pitié-Salpêtrière], Université Pierre et Marie Curie - Paris 6 (UPMC)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-CHU Pitié-Salpêtrière [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Sorbonne Université (SU), Défaillance Cardiovasculaire Aiguë et Chronique (DCAC), Centre Hospitalier Régional Universitaire de Nancy (CHRU Nancy)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Lorraine (UL), Centre Hospitalier Régional Universitaire de Nancy (CHRU Nancy), Centre Hospitalier Universitaire d'Angers (CHU Angers), PRES Université Nantes Angers Le Mans (UNAM)-PRES Université Nantes Angers Le Mans (UNAM), Hôpital Louis Mourier - AP-HP [Colombes], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-CHU Tenon [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Cochin [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU) |
| Jazyk: | angličtina |
| Rok vydání: | 2016 |
| Předmět: |
Mechanical ventilation
COPD Alkalosis [ SDV ] Life Sciences [q-bio] business.industry medicine.medical_treatment [SDV]Life Sciences [q-bio] Metabolic alkalosis 030208 emergency & critical care medicine General Medicine medicine.disease Placebo 3. Good health 03 medical and health sciences 0302 clinical medicine Sciences du Vivant [q-bio]/Autre [q-bio.OT] 030228 respiratory system Intensive care Anesthesia Multicenter trial medicine Acetazolamide business medicine.drug |
| Zdroj: | Journal of the American Medical Association Journal of the American Medical Association, American Medical Association (AMA), 2016, 315 (5), pp.480--488. 〈10.1001/jama.2016.0019〉 Journal of the American Medical Association, 2016, 315 (5), pp.480--488. ⟨10.1001/jama.2016.0019⟩ Journal of the American Medical Association, American Medical Association (AMA), 2016, 315 (5), pp.480--488. ⟨10.1001/jama.2016.0019⟩ |
| ISSN: | 0098-7484 1538-3598 |
| DOI: | 10.1001/jama.2016.0019〉 |
| Popis: | International audience; 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 \textless .001) and number of days with metabolic alkalosis (between-group difference, −1; 95% CI, −2 to −1 days; P \textless .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 |
| Databáze: | OpenAIRE |
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