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

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

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

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

Resource links provided by NLM:

Drug Information available for: Acetazolamide Acetazolamide sodium

U.S. FDA Resources

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 2009
Estimated Primary Completion Date:	December 2009 (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

No publications provided

Study ID Numbers:	AREMA
Study First Received:	September 14, 2005
Last Updated:	August 11, 2009
ClinicalTrials.gov Identifier:	NCT00222534 History of Changes
Health Authority:	Norway: Norwegian Medicines Agency

Keywords provided by University of Oslo School of Pharmacy:

Respiratory Insufficiency
Alkalosis

Additional relevant MeSH terms:

Metabolic Diseases
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Diuretics
Respiration Disorders
Acetazolamide
Enzyme Inhibitors
Cardiovascular Agents
Acid-Base Imbalance

Pharmacologic Actions
Carbonic Anhydrase Inhibitors
Respiratory Insufficiency
Respiratory Tract Diseases
Natriuretic Agents
Therapeutic Uses
Alkalosis
Central Nervous System Agents
Anticonvulsants

ClinicalTrials.gov processed this record on November 27, 2009