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CompletedNCT00222534Updated Jan 20, 2014

Acetazolamide for Respiratory Failure in Combination With Metabolic Alkalosis

A Phase 4 interventional study of Acetazolamide and Placebo in Respiratory Insufficiency and Alkalosis, sponsored by University of Oslo School of Pharmacy. Completed at 5 sites in Norway. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-01-20.

Sponsored by University of Oslo School of Pharmacy · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
70
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Respiratory Insufficiency
  • Alkalosis

Keywords

  • Respiratory Insufficiency
  • Alkalosis
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In context

Respiratory Insufficiency

1,650 studies on the registry are indexed under Respiratory Insufficiency; 296 are open to participants now.

This study's enrollment of 70 is above the median of 55 across 1,043 interventional studies indexed under Respiratory Insufficiency.

Browse Respiratory Insufficiency studies →

Lead sponsor

University of Oslo School of Pharmacy is the lead sponsor of 18 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
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Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
70 participants (actual)

Study arms

  • 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

Interventions

  • DrugAcetazolamide
  • DrugPlacebo
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What researchers measure

Primary outcomes

  1. Partial pressure of oxygen in arterial blood on the 5th day of treatment (without extra oxygen)

  2. Change in partial pressure of oxygen from start of treatment to the fifth day of treatment

Secondary outcomes

  1. Partial pressure of carbon dioxide in arterial blood on the 5th day of treatment.

  2. Change in partial pressure of carbon dioxide from start of treatment to the fifth day of treatment

  3. Intrahospital deaths

  4. Use of mechanical ventilation

  5. Length of stay

  6. Side effects

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Study locations

5 sites
  • Department of Respiratory Medicine, Haukeland University Hospital
    Bergen, Norway
  • Department of Internal Medicine, Sorlandet Sykehus Kristiansand
    Kristiansand, Norway
  • Department of Internal Medicine, Aker University Hospital
    Oslo, 0514, Norway
  • Ullevaal University Hospital, Dept. of Respiratory Medicine
    Oslo, NO-0407, Norway
  • Department of Internal Medicine, St.Olav's Hospital
    Trondheim, Norway
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References and documents

Publications

  • 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. PubMed 23578004 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 20, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00222534
Lead sponsor
University of Oslo School of Pharmacy
Responsible party
Torgeir Bruun Wyller (Professor, University of Oslo School of Pharmacy) — Principal investigator
First posted
Sep 22, 2005
Start date
Jan 2002
Primary completion
Dec 2009
Completion
Dec 2009
Last update
Jan 20, 2014

Study contacts

Torgeir B Wyller, MD, PhD
principal investigator · Department of Geriatric Medicine, Ullevaal University Hospital, Oslo, Norway
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2014. You cannot join it, but the record below documents what was studied.

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