Ignite Creation Date:
2025-12-25 @ 2:23 AM
Ignite Modification Date:
2026-01-07 @ 12:49 AM
Study NCT ID:
NCT00222534
Status:
COMPLETED
Last Update Posted:
2014-01-20
First Post:
2005-09-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Acetazolamide for Respiratory Failure in Combination With Metabolic Alkalosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012131', 'term': 'Respiratory Insufficiency'}, {'id': 'D000471', 'term': 'Alkalosis'}], 'ancestors': [{'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D000137', 'term': 'Acid-Base Imbalance'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000086', 'term': 'Acetazolamide'}], 'ancestors': [{'id': 'D013830', 'term': 'Thiadiazoles'}, {'id': 'D013844', 'term': 'Thiazoles'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 70}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-01', 'completionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-01-17', 'studyFirstSubmitDate': '2005-09-14', 'studyFirstSubmitQcDate': '2005-09-14', 'lastUpdatePostDateStruct': {'date': '2014-01-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'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'}], 'secondaryOutcomes': [{'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'}]}, 'conditionsModule': {'keywords': ['Respiratory Insufficiency', 'Alkalosis'], 'conditions': ['Respiratory Insufficiency', 'Alkalosis']}, 'referencesModule': {'references': [{'pmid': '23578004', 'type': 'RESULT', '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.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nWhen 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.\n\nIn 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.\n\nThus, 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Arterial pO2 8 kPa or lower, and arterial pCO2 7 kPa or higher.\n* Base Excess 8 mmmol/l or higher.\n* Written informed consent\n\nExclusion Criteria:\n\n* Acetazolamide treatment regarded as obviously indicated or obviously contraindicated\n* Already using acetazolamide\n* Moribund patient\n* Unable to give fully informed consent\n* Allergy towards the tablet content or unable to swallow the tablets\n* Pregnant or breast-feeding'}, 'identificationModule': {'nctId': 'NCT00222534', 'briefTitle': 'Acetazolamide for Respiratory Failure in Combination With Metabolic Alkalosis', 'organization': {'class': 'OTHER', 'fullName': 'University of Oslo School of Pharmacy'}, 'officialTitle': 'Acetazolamide for Respiratory Failure in Combination With Metabolic Alkalosis', 'orgStudyIdInfo': {'id': 'AREMA'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Acetazolamide', 'description': 'Acetazolamide 250 mg Three times a day for five days', 'interventionNames': ['Drug: Acetazolamide']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo, one tablet Three times a day for five days', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Acetazolamide', 'type': 'DRUG', 'armGroupLabels': ['Acetazolamide']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bergen', 'country': 'Norway', 'facility': 'Department of Respiratory Medicine, Haukeland University Hospital', 'geoPoint': {'lat': 60.39299, 'lon': 5.32415}}, {'city': 'Kristiansand', 'country': 'Norway', 'facility': 'Department of Internal Medicine, Sorlandet Sykehus Kristiansand', 'geoPoint': {'lat': 58.14671, 'lon': 7.9956}}, {'zip': '0514', 'city': 'Oslo', 'country': 'Norway', 'facility': 'Department of Internal Medicine, Aker University Hospital', 'geoPoint': {'lat': 59.91273, 'lon': 10.74609}}, {'zip': 'NO-0407', 'city': 'Oslo', 'country': 'Norway', 'facility': 'Ullevaal University Hospital, Dept. of Respiratory Medicine', 'geoPoint': {'lat': 59.91273, 'lon': 10.74609}}, {'city': 'Trondheim', 'country': 'Norway', 'facility': "Department of Internal Medicine, St.Olav's Hospital", 'geoPoint': {'lat': 63.43049, 'lon': 10.39506}}], 'overallOfficials': [{'name': 'Torgeir B Wyller, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Geriatric Medicine, Ullevaal University Hospital, Oslo, Norway'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Oslo School of Pharmacy', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Torgeir Bruun Wyller', 'investigatorAffiliation': 'University of Oslo School of Pharmacy'}}}}