Acetazolamide for Respiratory Failure in Combination With Metabolic Alkalosis

January 17, 2014 updated by: Torgeir Bruun Wyller, University of Oslo School of Pharmacy

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Bergen, Norway
        • Department of Respiratory Medicine, Haukeland University Hospital
      • Kristiansand, Norway
        • Department of Internal Medicine, Sorlandet Sykehus Kristiansand
      • Oslo, Norway, 0514
        • Department of Internal Medicine, Aker University Hospital
      • Oslo, Norway, NO-0407
        • Ullevaal University Hospital, Dept. of Respiratory Medicine
      • Trondheim, Norway
        • Department of Internal Medicine, St.Olav's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Acetazolamide
Acetazolamide 250 mg Three times a day for five days
Drug: Acetazolamide
Placebo Comparator: Placebo
Placebo, one tablet Three times a day for five days
Drug: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Oslo School of Pharmacy

Investigators

  • Principal Investigator: Torgeir B Wyller, MD, PhD, Department of Geriatric Medicine, Ullevaal University Hospital, Oslo, Norway

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2002

Primary Completion (Actual)

December 1, 2009

Study Completion (Actual)

December 1, 2009

Study Registration Dates

First Submitted

September 14, 2005

First Submitted That Met QC Criteria

September 14, 2005

First Posted (Estimate)

September 22, 2005

Study Record Updates

Last Update Posted (Estimate)

January 20, 2014

Last Update Submitted That Met QC Criteria

January 17, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AREMA

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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