Acetazolamide for Respiratory Failure in Combination With Metabolic Alkalosis
Information source: University of Oslo School of Pharmacy
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Respiratory Insufficiency; Alkalosis
Intervention: Acetazolamide (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: University of Oslo School of Pharmacy Official(s) and/or principal investigator(s):
Torgeir B Wyller, MD, PhD, Principal Investigator, Affiliation: Department of Geriatric Medicine, Ullevaal University Hospital, Oslo, Norway
Overall contact:
Torgeir B Wyller, MD, PhD, Phone: 22118702, Ext: +47, Email: t.b.wyller@medisin.uio.no
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.
Clinical Details
Official title: Acetazolamide for Respiratory Failure in Combination With Metabolic Alkalosis
Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
Primary outcome: 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 outcome: 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 Intrahospital deaths Use of mechanical ventilation Length of stay Side effects
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Torgeir B Wyller, MD, PhD, Phone: 22118702, Ext: +47, Email: t.b.wyller@medisin.uio.no
Department of Internal Medicine, Aker University Hospital, Oslo 0514, Norway; Recruiting
Ingunn Skjørten, MD
Ingun Skjørten, MD, Principal Investigator
Department of Internal Medicine, Sorlandet Sykehus Kristiansand, Kristiansand, Norway; Recruiting
Kenneth Undhjem, MD
Kenneth Undhjem, MD, Principal Investigator
Vasvija Lejlic, MD, Sub-Investigator
Department of Respiratory Medicine, Haukeland University Hospital, Bergen, Norway; Recruiting
Eirunn Waatevik, MD
Eirunn Waatevik, MD, Principal Investigator
Department of Internal Medicine, St.Olav's Hospital, Trondheim, Norway; Recruiting
Erik D Liaaen, MD
Erik D Liaaen, MD, Principal Investigator
Ullevaal University Hospital, Dept. of Respiratory Medicine, Oslo NO-0407, Norway; Recruiting
Morten Sand, MD, Phone: +4722118080
Fredrik Borchsenius, MD, Phone: +4722118080
Morten Sand, MD, Principal Investigator
Additional Information
Starting date: January 2002
Ending date: December 2008
Last updated: June 9, 2008
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