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

Phase 3

Completed

• Conditions: Obesity Hypoventilation Syndrome; Metabolic Alkalosis; Pulmonary Disease, Chronic Obstructive
• Interventions: Drug: Acetazolamide; Drug: Placebo

• Registration Number: NCT01499485
• Lead Sponsor: Hospital Son Llatzer

Brief 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.

Study Timeline

• Study Start: 2011-11
• Study First Submitted: 2011-12-20
• Study First Submitted QC: 2011-12-22
• Study First Posted: 2011-12-26
• Primary Completion: 2015-02
• Study Completion: 2015-02
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-16
• Last Update Posted: 2015-03-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 140

Inclusion Criteria

• Patients with COPD or obesity hypoventilation syndrome on invasive mechanical ventilation during less than 72 h with metabolic alkalosis, defined as a pH > 7.35 and actual bicarbonate > 28 mmol/L, and with potassium plasmatic levels >= 4 mEq/L.

Exclusion Criteria

• Postoperative patients.
• Previous psychiatric disease.
• Epilepsy.
• Pregnancy.
• Hepatic cirrhosis.
• Sulfonamide or acetazolamide allergy.
• Plasmatic creatinine > 2.5 mg/dL or creatinine clearance < 20 mL/min or continuous renal replacement techniques.
• Intolerance to enteral feeding.
• Administration in the previous 72 h of bicarbonate or acetazolamide.
• Terminal disease.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Acetazolamide	Acetazolamide	-
placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Length of mechanical ventilation	From intubation date to extubation date, an expected average of 1 week

Secondary Outcome Measures

Name	Time	Method
Length of intensive care unit stay	The duration of ICU stay, an expected average less than 2 weeks
All cause hospital mortality	Participants will be followed for the duration of hospital stay, an expected average of 3 weeks	Alive or dead status will be recorded at the end of hospital stay
Complications associated to the treatment	During the mechanical ventilation period, an expected average of 1 week	Plasma and urine analysis will be performed to detect alteration in electrolites or renal function.

Trial Locations

Locations (8)

Hospital de Manacor; 🇪🇸 Manacor, Illes Balears, Spain

Fundación Jiménez Díaz; 🇪🇸 Madrid, Comunidad de Madrid, Spain

Hospital Son Espases; 🇪🇸 Palma de Mallorca, Illes Balears, Spain

Hospital Son Llàtzer; 🇪🇸 Palma de Mallorca, Illes Balears, Spain

Hospital Universitario Infanta Leonor; 🇪🇸 Madrid, Comunidad de Madrid, Spain

Hospital de la Santa Creu i Sant Pau; 🇪🇸 Barcelona, Spain

Hospital de Sant Joan Despí Moisès Broggi; 🇪🇸 Sant Joan Despí, Barcelona, Spain

Fundació Hospital Asil de Granollers; 🇪🇸 Granollers, Barcelona, Spain