Acetazolamide for Respiratory Failure in Combination With Metabolic Alkalosis

Phase 4

Completed

• Conditions: Alkalosis; Respiratory Insufficiency
• Interventions: Drug: Placebo; Drug: Acetazolamide

• Registration Number: NCT00222534
• Lead Sponsor: University of Oslo School of Pharmacy

Brief Summary

Respiratory failure is a common consequence of chronic obstructive pulmonary disease (COPD). A concurrent metabolic alkalosis may worsen the respiratory failure, as a higher pH in blood (and thus in cerebrospinal fluid) results in a weaker respiratory drive. Use of diuretics is the most common cause of metabolic alkalosis.

When a patient with an acute exacerbation of a respiratory failure is also alkalotic, there are (at least theoretical) reasons to lower the pH in order to increase the respiratory drive. Among other alternatives, the drug acetazolamide can be used for this purpose.

In some hospitals there is a tradition for the use of acetazolamide on this indication, but any evidence for the effect of such a treatment is rather weak.

Thus, the aim of this trial is to evaluate the effect of acetazolamide as an adjuvant treatment for hospitalized patients with acute exacerbation of respiratory failure in combination with metabolic alkalosis.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-01
• Study First Submitted: 2005-09-14
• Study First Submitted QC: 2005-09-14
• Study First Posted: 2005-09-22
• Primary Completion: 2009-12
• Study Completion: 2009-12
• Status Verified: 2014-01
• Last Update Submitted: 2014-01-17
• Last Update Posted: 2014-01-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

• Arterial pO2 8 kPa or lower, and arterial pCO2 7 kPa or higher.
• Base Excess 8 mmmol/l or higher.
• Written informed consent

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Exclusion Criteria

• Acetazolamide treatment regarded as obviously indicated or obviously contraindicated
• Already using acetazolamide
• Moribund patient
• Unable to give fully informed consent
• Allergy towards the tablet content or unable to swallow the tablets
• Pregnant or breast-feeding

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo, one tablet Three times a day for five days
Acetazolamide	Acetazolamide	Acetazolamide 250 mg Three times a day for five days

Primary Outcome Measures

Name	Time	Method
Partial pressure of oxygen in arterial blood on the 5th day of treatment (without extra oxygen)
Change in partial pressure of oxygen from start of treatment to the fifth day of treatment

Secondary Outcome Measures

Name	Time	Method
Use of mechanical ventilation
Length of stay
Intrahospital deaths
Change in partial pressure of carbon dioxide from start of treatment to the fifth day of treatment
Partial pressure of carbon dioxide in arterial blood on the 5th day of treatment.
Side effects

Trial Locations

Locations (5)

Department of Internal Medicine, Sorlandet Sykehus Kristiansand; 🇳🇴 Kristiansand, Norway

Department of Internal Medicine, Aker University Hospital; 🇳🇴 Oslo, Norway

Department of Respiratory Medicine, Haukeland University Hospital; 🇳🇴 Bergen, Norway

Ullevaal University Hospital, Dept. of Respiratory Medicine; 🇳🇴 Oslo, Norway

Department of Internal Medicine, St.Olav's Hospital; 🇳🇴 Trondheim, Norway