Acetazolamide for Respiratory Failure in Combination With Metabolic Alkalosis

Sponsor

University of Oslo School of Pharmacy (Other)

Overall Status

Completed

CT.gov ID

NCT00222534

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Respiratory Insufficiency Alkalosis	Drug: Acetazolamide Drug: Placebo	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

70 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

Acetazolamide for Respiratory Failure in Combination With Metabolic Alkalosis

Study Start Date :

Jan 1, 2002

Actual Primary Completion Date :

Dec 1, 2009

Actual Study Completion Date :

Dec 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
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

Arm

Intervention/Treatment

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

Outcome Measures

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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	Country	Postal Code
1	Department of Respiratory Medicine, Haukeland University Hospital	Bergen	Norway
2	Department of Internal Medicine, Sorlandet Sykehus Kristiansand	Kristiansand	Norway
3	Department of Internal Medicine, Aker University Hospital	Oslo	Norway	0514
4	Ullevaal University Hospital, Dept. of Respiratory Medicine	Oslo	Norway	NO-0407
5	Department of Internal Medicine, St.Olav's Hospital	Trondheim	Norway