Clinical trial NCT00222534: Acetazolamide for Respiratory Failure in Combination With Metabolic Alkalosis
Official title: Acetazolamide for Respiratory Failure in Combination With Metabolic Alkalosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Respiratory Insufficiency
Alkalosis
Keywords: Respiratory Insufficiency
Alkalosis
Lead sponsor: University of Oslo School of Pharmacy
Sponsor class: OTHER
First posted: 2005-09-22
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Partial pressure of oxygen in arterial blood on the 5th day of treatment (without extra oxygen)
measure: Change in partial pressure of oxygen from start of treatment to the fifth day of treatment
Secondary outcomes:
measure: Partial pressure of carbon dioxide in arterial blood on the 5th day of treatment.
measure: Change in partial pressure of carbon dioxide from start of treatment to the fifth day of treatment
measure: Intrahospital deaths
measure: Use of mechanical ventilation
measure: Length of stay
measure: Side effects
Other outcomes:
Locations:
city: Bergen
country: Norway
facility: Department of Respiratory Medicine, Haukeland University Hospital
city: Kristiansand
country: Norway
facility: Department of Internal Medicine, Sorlandet Sykehus Kristiansand
city: Oslo
country: Norway
facility: Department of Internal Medicine, Aker University Hospital
city: Oslo
country: Norway
facility: Ullevaal University Hospital, Dept. of Respiratory Medicine
city: Trondheim
country: Norway
facility: Department of Internal Medicine, St.Olav's Hospital
Study officials:
affiliation: Department of Geriatric Medicine, Ullevaal University Hospital, Oslo, Norway
name: Torgeir B Wyller, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.