Acetazolamide for Respiratory Failure in Combination With Metabolic Alkalosis
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Enrollment
- 70
- Locations
- 5
- Primary Endpoint
- Partial pressure of oxygen in arterial blood on the 5th day of treatment (without extra oxygen)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- 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
- •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
Arms & Interventions
Acetazolamide
Acetazolamide 250 mg Three times a day for five days
Intervention: Acetazolamide (Drug)
Placebo
Placebo, one tablet Three times a day for five days
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
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
- Use of mechanical ventilation
- Length of stay
- Intrahospital deaths
- 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
- Side effects
Investigators
Torgeir Bruun Wyller
Professor
University of Oslo School of Pharmacy