Respiratory InsufficiencyPhase 4NCT00222534
Acetazolamide for Respiratory Failure in Combination With Metabolic Alkalosis
A Phase 4 study testing Acetazolamide in people with Respiratory Insufficiency and Alkalosis, run by University of Oslo School of Pharmacy at 5 sites in Norway.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory Insufficiency, Alkalosis
- What is being tested?
- Acetazolamide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 5 sitesNorway
- Study dates
- Jan 2002to Dec 2009
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Arterial pO2 8 kPa or lower, and arterial pCO2 7 kPa or higher.
- Base Excess 8 mmmol/l or higher.
- Written informed consent
Who cannot join
- 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 locations and contacts
5 sites in 1 country.
5 sites in 1 country
Norway5 sites
Department of Respiratory Medicine, Haukeland University Hospital
Bergen
Department of Internal Medicine, Sorlandet Sykehus Kristiansand
Kristiansand
Department of Internal Medicine, Aker University Hospital
Oslo, 0514
Ullevaal University Hospital, Dept. of Respiratory Medicine
Oslo, NO-0407
Department of Internal Medicine, St.Olav's Hospital
Trondheim
About this study
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.
Read more
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.
- Conditions
- Respiratory Insufficiency, Alkalosis
- Being tested
- Acetazolamide, Placebo
- Keywords
- Respiratory Insufficiency, Alkalosis
- Medical subject headings
- Respiratory Insufficiency, Alkalosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcetazolamideDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Acetazolamide | Experimental | Acetazolamide 250 mg Three times a day for five days Receives: Drug: Acetazolamide |
| Placebo | Placebo comparator | Placebo, one tablet Three times a day for five days Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 (6)
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startJan 2002
- Primary completionDec 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Respiratory InsufficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oslo School of Pharmacy
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Torgeir Bruun Wyller, University of Oslo School of Pharmacy
- Investigators
- Torgeir B Wyller, MD, PhD, Principal investigator, Department of Geriatric Medicine, Ullevaal University Hospital, Oslo, Norway
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00222534
- Sponsor's protocol ID
- AREMA
- Status last verified
- Jan 2014
- First submitted
- 14 Sep 2005
- Last updated
- 20 Jan 2014
- Results posted
- No
Publications
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.
PubMed 23578004
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acetazolamide for Respiratory Failure in Combination With Metabolic Alkalosis
- ClinicalTrials.gov ID
- NCT00222534
- Acronym / sponsor ID
- AREMA
- Conditions
- Respiratory Insufficiency, Alkalosis
- Keywords
- Respiratory Insufficiency, Alkalosis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- University of Oslo School of PharmacyUniversity, hospital or other
- Study start
- Jan 2002
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 22 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acetazolamide | Experimental | Drug: AcetazolamideAcetazolamide 250 mg Three times a day for five days |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo, one tablet Three times a day for five days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Arterial pO2 8 kPa or lower, and arterial pCO2 7 kPa or higher.
- Base Excess 8 mmmol/l or higher.
- Written informed consent
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acetazolamide | Drug | Acetazolamide |
| Placebo | Drug | Placebo |
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
6 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2014.
- Results publication: PubMed 23578004Gulsvik 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Torgeir B Wyller, MD, PhD principal investigator
Department of Geriatric Medicine, Ullevaal University Hospital, Oslo, Norway
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Acetazolamide in people with Respiratory Insufficiency and Alkalosis, run by University of Oslo School of Pharmacy at 5 sites in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Partial pressure of oxygen in arterial blood on the 5th day of treatment (without extra oxygen). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00222534, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2014.