NCT01499485

Treatment of Metabolic Alkalosis With Acetazolamide. Effect on the Length of Mechanical Ventilation.

Effects of Acetazolamide on the Duration of Mechanical Ventilation in Patients With Metabolic Alkalosis. Phase III Multicenter Double-blinded Clinical Trial.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 140 (actual)
• Sponsor: Hospital Son Llatzer · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed description

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.

Conditions

• Pulmonary Disease, Chronic Obstructive
• Obesity Hypoventilation Syndrome
• Metabolic Alkalosis

Interventions

Type	Name	Description
DRUG	Acetazolamide	Daily morning ABGA: * If actual bicarbonate \> 26 mmol/L and pH \> 7.35: administration of enteral capsule of acetazolamide 500 mg . * If actual bicarbonate \> 26 mmol/L and pH \<= 7.35, increase minute ventilation to reach pH \> 7.35 and then administer enteral capsule of acetazolamide 500 mg. * If actual bicarbonate \<= 26 mmol/L: omit treatment that day.
DRUG	Placebo	Daily morning ABGA: * If actual bicarbonate \> 26 mmol/L and pH \> 7.35: administration of enteral capsule of placebo. * If actual bicarbonate \> 26 mmol/L and pH \<= 7.35, increase minute ventilation to reach pH \> 7.35 and then administer enteral capsule of placebo. * If actual bicarbonate \<= 26 mmol/L: omit treatment that day.

Timeline

• Start date: 2011-11-01
• Primary completion: 2015-02-01
• Completion: 2015-02-01
• First posted: 2011-12-26
• Last updated: 2015-03-17

Locations

8 sites across 1 country: Spain