Acetazolamide for Respiratory Failure in Combination With Metabolic Alkalosis

Respiratory Insufficiency Clinical Trial

Official title:

Acetazolamide for Respiratory Failure in Combination With Metabolic Alkalosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00222534
• Other study ID #: AREMA
• Status: Completed
• Phase: Phase 4
• First received: September 14, 2005
• Last updated: January 17, 2014
• Start date: January 2002
• Est. completion date: December 2009

Study information

• Verified date: January 2014
• Source: University of Oslo School of Pharmacy
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Norwegian Medicines Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alkalosis
• Pulmonary Valve Insufficiency
• Respiratory Insufficiency

Intervention

Drug:
• Acetazolamide

• Placebo

Locations

Country	Name	City	State
Norway	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
Norway	Ullevaal University Hospital, Dept. of Respiratory Medicine	Oslo
Norway	Department of Internal Medicine, St.Olav's Hospital	Trondheim

Sponsors (1)

Lead Sponsor	Collaborator
University of Oslo School of Pharmacy

Country where clinical trial is conducted

Norway, 

References & Publications (1)

Gulsvik R, Skjørten I, Undhjem K, Holø 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: 10.11 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Partial pressure of oxygen in arterial blood on the 5th day of treatment (without extra oxygen)
Primary	Change in partial pressure of oxygen from start of treatment to the fifth day of treatment
Secondary	Partial pressure of carbon dioxide in arterial blood on the 5th day of treatment.
Secondary	Change in partial pressure of carbon dioxide from start of treatment to the fifth day of treatment
Secondary	Intrahospital deaths
Secondary	Use of mechanical ventilation
Secondary	Length of stay
Secondary	Side effects