CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 140 enrolled
Drug / intervention
Acetazolamide +1 moredrug
Likely dose
Acetazolamide 500 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01499485
NCT01499485Phase 3Completed
CompareCT.gov

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

Hospital Son Llatzer·interventional·Posted Dec 26, 2011·Updated Mar 17, 2015

In Brief

A Phase 3 clinical trial evaluating Acetazolamide and Placebo for Pulmonary Disease, Chronic Obstructive and 2 related conditions. Completed, enrolled 140 participants across 8 sites.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPulmonary Disease, Chronic Obstructive, Obesity Hypoventilation Syndrome, Metabolic Alkalosis
CountriesSpain
Collaborators--

Timeline

Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedDec 26, 2011
Enrollment StartNov 1, 2011
Primary CompletionFeb 1, 2015
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 14.5 years ago

Interventions

Acetazolamidedrug

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.

Placebodrug

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.