Ignite Creation Date:
2025-12-25 @ 3:19 AM
Ignite Modification Date:
2025-12-26 @ 1:57 AM
Study NCT ID:
NCT00877305
Status:
COMPLETED
Last Update Posted:
2012-01-18
First Post:
2009-04-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Remote Ischemic Preconditioning on Cognitive Function After Cardiac Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 180}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-01', 'lastUpdateSubmitDate': '2012-01-17', 'studyFirstSubmitDate': '2009-04-06', 'studyFirstSubmitQcDate': '2009-04-06', 'lastUpdatePostDateStruct': {'date': '2012-01-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-04-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The primary outcome measure is postoperative neurocognitive dysfunction.', 'timeFrame': 'Preoperative, 1 week and 3 months after surgery'}], 'secondaryOutcomes': [{'measure': 'New onset of atrial fibrillation, myocardial and kidney injury, cardiac function (previous NCT00882622 study).', 'timeFrame': 'Within 24-48 hours after surgery'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Ischemic Preconditioning', 'Cognitive function'], 'conditions': ['Cardiac Surgery']}, 'referencesModule': {'references': [{'pmid': '24712447', 'type': 'DERIVED', 'citation': 'Zitta K, Meybohm P, Bein B, Gruenewald M, Lauer F, Steinfath M, Cremer J, Zacharowski K, Albrecht M. Activities of cardiac tissue matrix metalloproteinases 2 and 9 are reduced by remote ischemic preconditioning in cardiosurgical patients with cardiopulmonary bypass. J Transl Med. 2014 Apr 8;12:94. doi: 10.1186/1479-5876-12-94.'}, {'pmid': '23741380', 'type': 'DERIVED', 'citation': 'Meybohm P, Renner J, Broch O, Caliebe D, Albrecht M, Cremer J, Haake N, Scholz J, Zacharowski K, Bein B. Postoperative neurocognitive dysfunction in patients undergoing cardiac surgery after remote ischemic preconditioning: a double-blind randomized controlled pilot study. PLoS One. 2013 May 31;8(5):e64743. doi: 10.1371/journal.pone.0064743. Print 2013.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the effects of Remote Ischemic Preconditioning on cognitive function in patients undergoing cardiac surgery compared to control intervention.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient undergoing heart surgery on cardiopulmonary bypass\n\nExclusion Criteria:\n\n* Emergency cases\n* Myocardial infarction up to 7 days prior to enrollment\n* Stroke up to 2 months prior to enrollment\n* Ejection fraction less than 30%\n* Previous psychiatric and neurological illness\n* Inability to give informed consent'}, 'identificationModule': {'nctId': 'NCT00877305', 'briefTitle': 'Effect of Remote Ischemic Preconditioning on Cognitive Function After Cardiac Surgery', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital Schleswig-Holstein'}, 'orgStudyIdInfo': {'id': 'A165/08'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'RIPC', 'description': 'Remote Ischemic Preconditioning', 'interventionNames': ['Procedure: Remote Ischemic Preconditioning']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'CONTROL', 'description': 'Control', 'interventionNames': ['Other: Control']}], 'interventions': [{'name': 'Remote Ischemic Preconditioning', 'type': 'PROCEDURE', 'description': 'RIPC will be induced during anesthesia by four 5-min cycles of upper limb ischemia and 5-min reperfusion using a blood-pressure cuff inflated to 200 mmHg (at least a pressure 15 mm Hg greater than the systolic arterial pressure measured via the arterial line).', 'armGroupLabels': ['RIPC']}, {'name': 'Control', 'type': 'OTHER', 'description': 'Sham intervention with four 5-min cycles of inflation of the blood pressure cuff at 20 mmHg and 5 min deflation without any upper leg ischaemia.', 'armGroupLabels': ['CONTROL']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Kiel', 'country': 'Germany', 'facility': 'University Hospital Schleswig-Holstein', 'geoPoint': {'lat': 54.32133, 'lon': 10.13489}}], 'overallOfficials': [{'name': 'Patrick Meybohm, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital Schleswig-Holstein'}, {'name': 'Berthold Bein, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital Schleswig-Holstein'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Patrick Meybohm', 'class': 'OTHER'}, 'collaborators': [{'name': 'University Hospital Schleswig-Holstein', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'PD Dr.', 'investigatorFullName': 'Patrick Meybohm', 'investigatorAffiliation': 'University Hospital Schleswig-Holstein'}}}}