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NCT Number: NCT00222534

Acetazolamide for Respiratory Failure in Combination With Metabolic Alkalosis

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Department of Respiratory Medicine, Haukeland University Hospital, Bergen, Norway

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Acetazolamide

Drug

Placebo

Drug

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

Sponsors and collaborators

Lead sponsor

University of Oslo School of Pharmacy

Other

Registry information

Important dates

Study start
2002
Primary completion
2009
Study completion
2009
First posted
Sep 22, 2005
Registry last updated
Jan 20, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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