Acetazolamide for Respiratory Failure in Combination With Metabolic Alkalosis - Tabular View

Tracking Information

First Received Date ^ICMJE

September 14, 2005

Last Updated Date

August 11, 2009

Start Date ^ICMJE

January 2002

Estimated Primary Completion Date

December 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00222534 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

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 mecahnical ventilation
Length of stay
Side effects

Descriptive Information

Brief Title ^ICMJE

Acetazolamide for Respiratory Failure in Combination With Metabolic Alkalosis

Official Title ^ICMJE

Acetazolamide for Respiratory Failure in Combination With Metabolic Alkalosis

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

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study

Condition ^ICMJE

Respiratory Insufficiency
Alkalosis

Intervention ^ICMJE

Drug: Acetazolamide

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

December 2009

Estimated Primary Completion Date

December 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Torgeir B Wyller, MD, PhD

22118702 ext +47

t.b.wyller@medisin.uio.no

Location Countries ^ICMJE

Norway

Administrative Information

NCT ID ^ICMJE

NCT00222534

Responsible Party

Study ID Numbers ^ICMJE

AREMA

Study Sponsor ^ICMJE

University of Oslo School of Pharmacy

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Torgeir B Wyller, MD, PhD

Department of Geriatric Medicine, Ullevaal University Hospital, Oslo, Norway

Information Provided By

University of Oslo School of Pharmacy

Verification Date

August 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP