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Acetazolamide for Respiratory Failure in Combination With Metabolic Alkalosis

U

University of Oslo School of Pharmacy

Status and phase

Completed
Phase 4

Conditions

Respiratory Insufficiency
Alkalosis

Treatments

Drug: Placebo
Drug: Acetazolamide

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Enrollment

70 patients

Sex

All

Ages

18+ years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

70 participants in 2 patient groups, including a placebo group

Acetazolamide
Experimental group
Description:
Acetazolamide 250 mg Three times a day for five days
Treatment:
Drug: Acetazolamide
Placebo
Placebo Comparator group
Description:
Placebo, one tablet Three times a day for five days
Treatment:
Drug: Placebo

Trial contacts and locations

5

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Data sourced from clinicaltrials.gov

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