Ignite Creation Date:
2025-12-24 @ 3:56 PM
Ignite Modification Date:
2026-02-25 @ 7:18 AM
Study NCT ID:
NCT02329392
Status:
COMPLETED
Last Update Posted:
2016-04-29
First Post:
2014-12-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessment of Skin Perfusion Pressure as an Indicator of Tissue Oxygenation in Cardiac Surgery Patients Undergoing Cardiopulmonary Bypass
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 72}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-04', 'completionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-04-28', 'studyFirstSubmitDate': '2014-12-29', 'studyFirstSubmitQcDate': '2014-12-29', 'lastUpdatePostDateStruct': {'date': '2016-04-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-12-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assessment of skin perfusion pressure', 'timeFrame': 'From post induction to 6 hours'}], 'secondaryOutcomes': [{'measure': 'Assessment of arterial lactate level', 'timeFrame': 'From post induction to 48 hours'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Peripheral Circulation During On-pump Cardiac Surgery']}, 'descriptionModule': {'briefSummary': 'This study is aim to evaluate usefulness of the perioperative monitoring of skin perfusion pressure as an indicator of perpheral perfusion in patients undergoing on-pump cardiac surgery. Association of the intraoperative and postoperative 6hr skin perfusion pressure with perioperative serum lactate level is going to be assessed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patinets \\> 20 years old who are scheduled for elective on-pump cardiac surgery', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age \\> 20 yrs, scheduled for elective on-pump cardiac surgery\n\nExclusion Criteria:\n\n* known peripheral arterial occlusive disease, patients without swan ganz catheter insertion, heart transplantation, infective endocarditis, emergency surgery, hemodynamic instability requiring vasopressor, preoperative lactate \\> 2mmol/L, known liver cirrhosis, pregnant, cognitive dysfunction, being unable to communicate'}, 'identificationModule': {'nctId': 'NCT02329392', 'briefTitle': 'Assessment of Skin Perfusion Pressure as an Indicator of Tissue Oxygenation in Cardiac Surgery Patients Undergoing Cardiopulmonary Bypass', 'organization': {'class': 'OTHER', 'fullName': 'Yonsei University'}, 'orgStudyIdInfo': {'id': '1-2014-0070'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'SPP', 'description': 'Patients undergoing cardiac surgery with perioperative monitoring of Skin Perfusion Pressure'}]}, 'contactsLocationsModule': {'locations': [{'zip': '03722', 'city': 'Seoul', 'state': 'Seoul', 'country': 'South Korea', 'facility': 'Severance Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yonsei University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}