Acetazolamide for Respiratory Failure in Combination With Metabolic Alkalosis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Torgeir Bruun Wyller, University of Oslo School of Pharmacy
ClinicalTrials.gov Identifier:
NCT00222534
First received: September 14, 2005
Last updated: January 17, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention Phase
Respiratory Insufficiency
Alkalosis
Drug: Acetazolamide
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Acetazolamide for Respiratory Failure in Combination With Metabolic Alkalosis

Resource links provided by NLM:


Further study details as provided by University of Oslo School of Pharmacy:

Primary Outcome Measures:
  • 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:
  • 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
  • Length of stay
  • Side effects

Enrollment: 70
Study Start Date: January 2002
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00222534

Locations
Norway
Department of Respiratory Medicine, Haukeland University Hospital
Bergen, Norway
Department of Internal Medicine, Sorlandet Sykehus Kristiansand
Kristiansand, Norway
Department of Internal Medicine, Aker University Hospital
Oslo, Norway, 0514
Ullevaal University Hospital, Dept. of Respiratory Medicine
Oslo, Norway, NO-0407
Department of Internal Medicine, St.Olav's Hospital
Trondheim, Norway
Sponsors and Collaborators
University of Oslo School of Pharmacy
Investigators
Principal Investigator: Torgeir B Wyller, MD, PhD Department of Geriatric Medicine, Ullevaal University Hospital, Oslo, Norway
  More Information

Publications:
Responsible Party: Torgeir Bruun Wyller, Professor, University of Oslo School of Pharmacy
ClinicalTrials.gov Identifier: NCT00222534     History of Changes
Other Study ID Numbers: AREMA
Study First Received: September 14, 2005
Last Updated: January 17, 2014
Health Authority: Norway: Norwegian Medicines Agency

Keywords provided by University of Oslo School of Pharmacy:
Respiratory Insufficiency
Alkalosis

Additional relevant MeSH terms:
Respiratory Insufficiency
Alkalosis
Respiration Disorders
Respiratory Tract Diseases
Acid-Base Imbalance
Metabolic Diseases
Acetazolamide
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Carbonic Anhydrase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Cardiovascular Agents

ClinicalTrials.gov processed this record on September 18, 2014