NCT00222534

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jan 2002

Longer than P75 for phase_4

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2002

Completed
3.7 years until next milestone

First Submitted

Initial submission to the registry

September 14, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

January 20, 2014

Status Verified

January 1, 2014

Enrollment Period

7.9 years

First QC Date

September 14, 2005

Last Update Submit

January 17, 2014

Conditions

Respiratory InsufficiencyAlkalosis

Keywords

Respiratory InsufficiencyAlkalosis

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (6)

  • 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

  • +1 more secondary outcomes

Study Arms (2)

Acetazolamide

EXPERIMENTAL

Acetazolamide 250 mg Three times a day for five days

Drug: Acetazolamide

Placebo

PLACEBO COMPARATOR

Placebo, one tablet Three times a day for five days

Drug: Placebo

Interventions

AcetazolamideDRUG
Acetazolamide
PlaceboDRUG
Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Arterial pO2 8 kPa or lower, and arterial pCO2 7 kPa or higher.
  • Base Excess 8 mmmol/l or higher.
  • Written informed consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Department of Respiratory Medicine, Haukeland University Hospital

Bergen, Norway

Location

Department of Internal Medicine, Sorlandet Sykehus Kristiansand

Kristiansand, Norway

Location

Department of Internal Medicine, Aker University Hospital

Oslo, 0514, Norway

Location

Ullevaal University Hospital, Dept. of Respiratory Medicine

Oslo, NO-0407, Norway

Location

Department of Internal Medicine, St.Olav's Hospital

Trondheim, Norway

Location

Related Publications (1)

  • 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.

    PMID: 23578004RESULT

MeSH Terms

Conditions

Respiratory InsufficiencyAlkalosis

Interventions

Acetazolamide

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesAcid-Base ImbalanceMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

ThiadiazolesThiazolesSulfur CompoundsOrganic ChemicalsAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Torgeir B Wyller, MD, PhD

    Department of Geriatric Medicine, Ullevaal University Hospital, Oslo, Norway

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 14, 2005

First Posted

September 22, 2005

Study Start

January 1, 2002

Primary Completion

December 1, 2009

Study Completion

December 1, 2009

Last Updated

January 20, 2014

Record last verified: 2014-01

Locations

NO(5)