Acetazolamide for Respiratory Failure in Combination With Metabolic Alkalosis - Full Text View

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	Phase IV

ChemIDplus related topics:

Acetazolamide Acetazolamide sodium

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study

Official Title:	Acetazolamide for Respiratory Failure in Combination With Metabolic Alkalosis

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

Estimated Enrollment:	90
Study Start Date:	January 2002
Estimated Study Completion Date:	December 2008
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

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

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

Contacts


Contact: Torgeir B Wyller, MD, PhD	22118702 ext +47	t.b.wyller@medisin.uio.no

Locations


Norway
	Department of Internal Medicine, Aker University Hospital	Recruiting
	Oslo, Norway, 0514
	Contact: Ingunn Skjørten, MD
	Principal Investigator: Ingun Skjørten, MD
	Department of Internal Medicine, Sorlandet Sykehus Kristiansand	Recruiting
	Kristiansand, Norway
	Contact: Kenneth Undhjem, MD
	Principal Investigator: Kenneth Undhjem, MD
	Sub-Investigator: Vasvija Lejlic, MD
	Department of Respiratory Medicine, Haukeland University Hospital	Recruiting
	Bergen, Norway
	Contact: Eirunn Waatevik, MD
	Principal Investigator: Eirunn Waatevik, MD
	Department of Internal Medicine, St.Olav's Hospital	Recruiting
	Trondheim, Norway
	Contact: Erik D Liaaen, MD
	Principal Investigator: Erik D Liaaen, MD
	Ullevaal University Hospital, Dept. of Respiratory Medicine	Recruiting
	Oslo, Norway, NO-0407
	Contact: Morten Sand, MD +4722118080
	Contact: Fredrik Borchsenius, MD +4722118080
	Principal Investigator: Morten Sand, MD

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

Study ID Numbers:	AREMA
First Received:	September 14, 2005
Last Updated:	June 9, 2008
ClinicalTrials.gov Identifier:	NCT00222534
Health Authority:	Norway: Norwegian Medicines Agency

Keywords provided by University of Oslo School of Pharmacy:

Respiratory Insufficiency

Alkalosis

Study placed in the following topic categories:

Metabolic Diseases

Respiratory Insufficiency

Respiratory Tract Diseases

Respiration Disorders

Acetazolamide

Metabolic disorder

Alkalosis

Additional relevant MeSH terms:

Carbonic Anhydrase Inhibitors

Molecular Mechanisms of Pharmacological Action

Natriuretic Agents

Therapeutic Uses

Physiological Effects of Drugs

Diuretics

Enzyme Inhibitors

Cardiovascular Agents

Central Nervous System Agents

Pharmacologic Actions

Anticonvulsants

Acid-Base Imbalance

ClinicalTrials.gov processed this record on October 03, 2008

Sponsored by:	University of Oslo School of Pharmacy
Information provided by:	University of Oslo School of Pharmacy
ClinicalTrials.gov Identifier:	NCT00222534