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Acetazolamide for Respiratory Failure in Combination With Metabolic Alkalosis

Primary Purpose

Respiratory Insufficiency, Alkalosis

Status
Completed
Phase
Phase 4
Locations
Norway
Study Type
Interventional
Intervention
Acetazolamide
Placebo
Sponsored by
University of Oslo School of Pharmacy
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Respiratory Insufficiency focused on measuring Respiratory Insufficiency, Alkalosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Department of Respiratory Medicine, Haukeland University Hospital
  • Department of Internal Medicine, Sorlandet Sykehus Kristiansand
  • Department of Internal Medicine, Aker University Hospital
  • Ullevaal University Hospital, Dept. of Respiratory Medicine
  • Department of Internal Medicine, St.Olav's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Acetazolamide

Placebo

Arm Description

Acetazolamide 250 mg Three times a day for five days

Placebo, one tablet Three times a day for five days

Outcomes

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

Full Information

First Posted
September 14, 2005
Last Updated
January 17, 2014
Sponsor
University of Oslo School of Pharmacy
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1. Study Identification

Unique Protocol Identification Number
NCT00222534
Brief Title
Acetazolamide for Respiratory Failure in Combination With Metabolic Alkalosis
Official Title
Acetazolamide for Respiratory Failure in Combination With Metabolic Alkalosis
Study Type
Interventional

2. Study Status

Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
January 2002 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
December 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Oslo School of Pharmacy

4. Oversight

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Insufficiency, Alkalosis
Keywords
Respiratory Insufficiency, Alkalosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Acetazolamide
Arm Type
Experimental
Arm Description
Acetazolamide 250 mg Three times a day for five days
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo, one tablet Three times a day for five days
Intervention Type
Drug
Intervention Name(s)
Acetazolamide
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Partial pressure of oxygen in arterial blood on the 5th day of treatment (without extra oxygen)
Title
Change in partial pressure of oxygen from start of treatment to the fifth day of treatment
Secondary Outcome Measure Information:
Title
Partial pressure of carbon dioxide in arterial blood on the 5th day of treatment.
Title
Change in partial pressure of carbon dioxide from start of treatment to the fifth day of treatment
Title
Intrahospital deaths
Title
Use of mechanical ventilation
Title
Length of stay
Title
Side effects

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Torgeir B Wyller, MD, PhD
Organizational Affiliation
Department of Geriatric Medicine, Ullevaal University Hospital, Oslo, Norway
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Respiratory Medicine, Haukeland University Hospital
City
Bergen
Country
Norway
Facility Name
Department of Internal Medicine, Sorlandet Sykehus Kristiansand
City
Kristiansand
Country
Norway
Facility Name
Department of Internal Medicine, Aker University Hospital
City
Oslo
ZIP/Postal Code
0514
Country
Norway
Facility Name
Ullevaal University Hospital, Dept. of Respiratory Medicine
City
Oslo
ZIP/Postal Code
NO-0407
Country
Norway
Facility Name
Department of Internal Medicine, St.Olav's Hospital
City
Trondheim
Country
Norway

12. IPD Sharing Statement

Citations:
PubMed Identifier
23578004
Citation
Gulsvik R, Skjorten I, Undhjem K, Holo L, Frostad A, Saure EW, Lejlic V, Humerfelt S, Hansen G, Bruun Wyller T. Acetazolamide improves oxygenation in patients with respiratory failure and metabolic alkalosis. Clin Respir J. 2013 Oct;7(4):390-6. doi: 10.1111/crj.12025. Epub 2013 Jul 4.
Results Reference
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Acetazolamide for Respiratory Failure in Combination With Metabolic Alkalosis

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