Pulmonary Disease, Chronic Obstructive Clinical Trial
Official title:
Effects of Acetazolamide on the Duration of Mechanical Ventilation in Patients With Metabolic Alkalosis. Phase III Multicenter Double-blinded Clinical Trial.
The purpose of this study is to analyze whether the treatment of metabolic alkalosis with acetazolamide in intubated patients with chronic obstructive pulmonary disease (COPD) or with obesity hypoventilation syndrome (OHS) reduces the length of mechanical ventilation (MV).
Metabolic alkalosis (MA) may reduce central respiratory drive, cardiac output and worsen
oxygenation, leading to a delay in weaning from MV. Acetazolamide is a carbonic anhydrase
inhibitor that is able to correct MA and to stimulate respiratory drive. There is a paucity
of studies on the outcome of patients with MA under MV treated with acetazolamide.
The primary objective of our study is to analyze whether the treatment of MA with
acetazolamide in intubated patients with COPD or with OHS reduces the length of MV, reduces
the length of ICU stay or ICU mortality. Complications associated with acetazolamide
treatment will be also analyzed.
Phase III double-blinded trial, with COPD or OHS patients under MV who have pH > 7,35 and
bicarbonate > 28 mEq/L. Patients will be randomized to receive 500 mg of acetazolamide or
placebo. According to arterial blood gas analysis (ABGA) values treatment administration
will be evaluated daily until extubation.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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