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| 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 |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Torgeir B Wyller, MD, PhD | 22118702 ext +47 | t.b.wyller@medisin.uio.no |
| 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 | |
| Principal Investigator: | Torgeir B Wyller, MD, PhD | Department of Geriatric Medicine, Ullevaal University Hospital, Oslo, Norway |
More Information
| 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 |
|
Respiratory Insufficiency Alkalosis |
|
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 |
