Ignite Creation Date:
2025-12-25 @ 12:14 AM
Ignite Modification Date:
2025-12-25 @ 10:15 PM
Study NCT ID:
NCT00202358
Status:
UNKNOWN
Last Update Posted:
2008-06-17
First Post:
2005-09-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Perioperative Effect of Atenolol on Cytokine Profiles
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007249', 'term': 'Inflammation'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001262', 'term': 'Atenolol'}], 'ancestors': [{'id': 'D050198', 'term': 'Phenoxypropanolamines'}, {'id': 'D011412', 'term': 'Propanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D020005', 'term': 'Propanols'}, {'id': 'D000588', 'term': 'Amines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2002-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-06', 'completionDateStruct': {'date': '2008-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2008-06-13', 'studyFirstSubmitDate': '2005-09-12', 'studyFirstSubmitQcDate': '2005-09-12', 'lastUpdatePostDateStruct': {'date': '2008-06-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postoperative levels of IL-6 and C-Reactive protein', 'timeFrame': '6 hrs, 48 hrs, 6 weeks'}], 'secondaryOutcomes': [{'measure': 'IL-10, TNF-α', 'timeFrame': '6 hrs, 48 hrs, 6 weeks'}]}, 'conditionsModule': {'keywords': ['perioperative', 'beta-blockers', 'inflammation', 'outcomes'], 'conditions': ['Surgery']}, 'descriptionModule': {'briefSummary': 'Studies have shown that beta-blockers such as atenolol when given in the perioperative period reduce morbidity and mortality. One study showed that atenolol given just during the surgery period, seemed to improve outcomes up to 2 years later. This is hard to explain since beta-blockers act on the body by blocking the effects of adrenalin and thereby lowering heart rate and blood pressure.\n\nThis study is designed to find out if perioperative atenolol might exert its long term effects through an anti-inflammatory mechanism rather than by lowering heart rate and blood pressure. It is known that inflammation increases after surgery as part of the healing process. However, it is also becoming clear that low-grade chronic inflammation can also lead to long term adverse effects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* elective abdominal, orthopedic, or gynecologic surgery\n* ability to give informed consent\n* ability to tolerate beta-blocker therapy\n* ability to comply with follow-up requirements\n\nExclusion Criteria:\n\n* currently receiving beta-blocker therapy\n* EKG documented 2nd or 3rd degree heart block\n* EKG documented sinus bradycardia\n* Serum creatinine \\> 2.0\n* current treatment asthma\n* history of rheumatoid arthritis\n* history of Crohn's disease\n* history of lupus\n* history of inflammatory cancer"}, 'identificationModule': {'nctId': 'NCT00202358', 'briefTitle': 'Perioperative Effect of Atenolol on Cytokine Profiles', 'organization': {'class': 'OTHER', 'fullName': 'Saini Foundation'}, 'officialTitle': 'The Effect of Perioperative Atenolol on Post-Operative Cytokines', 'orgStudyIdInfo': {'id': 'PEACK'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'interventionNames': ['Drug: placebo']}, {'type': 'EXPERIMENTAL', 'label': 'atenolol', 'interventionNames': ['Drug: atenolol']}], 'interventions': [{'name': 'atenolol', 'type': 'DRUG', 'armGroupLabels': ['atenolol']}, {'name': 'placebo', 'type': 'DRUG', 'armGroupLabels': ['placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02601', 'city': 'Hyannis', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Cape Cod Hospital', 'geoPoint': {'lat': 41.65289, 'lon': -70.2828}}], 'overallOfficials': [{'name': 'Vikas Saini, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dept Medicine, Cape Cod Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Saini Foundation', 'class': 'OTHER'}, 'collaborators': [{'name': 'Medtronic - MITG', 'class': 'INDUSTRY'}], 'responsibleParty': {'oldNameTitle': 'Vikas Saini, M.D.', 'oldOrganization': 'Cape Cod Hospital'}}}}