Ignite Creation Date:
2025-12-25 @ 4:27 AM
Ignite Modification Date:
2025-12-26 @ 3:30 AM
Study NCT ID:
NCT03423420
Status:
COMPLETED
Last Update Posted:
2019-07-25
First Post:
2018-01-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Pontos-Central Venous Pressure and Cardiac Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 5945}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2013-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-07-23', 'studyFirstSubmitDate': '2018-01-25', 'studyFirstSubmitQcDate': '2018-02-02', 'lastUpdatePostDateStruct': {'date': '2019-07-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-02-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2013-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'priority of surgery', 'timeFrame': 'an average of 1 day', 'description': 'priority of surgery selected from a three point categorial scale with the categories elective, urgent and emergency'}, {'measure': 'type of surgery', 'timeFrame': 'an average of 1 day', 'description': 'type of surgery selected from the three point categorial scale with categories bypass graft, valve replacement or combination of both'}, {'measure': 'duration', 'timeFrame': 'an average of 4 hours', 'description': 'duration of surgery'}, {'measure': 'APACHE II', 'timeFrame': 'an average of 30 days', 'description': 'APACHE II Score of patients on admission on the ICU'}, {'measure': 'ACEF Score', 'timeFrame': 'an average of 1 day', 'description': 'preoperative ACEF Score of patients undergoing surgery'}], 'primaryOutcomes': [{'measure': 'mortality', 'timeFrame': 'an average of 30 days', 'description': 'In-Hospital mortality'}], 'secondaryOutcomes': [{'measure': 'Central venous pressure', 'timeFrame': 'intensive care unit stay, an average of 5 days', 'description': 'central venous pressure on intensive care unit'}, {'measure': 'Hospital stay', 'timeFrame': 'an average of 13 days', 'description': 'Length of hospital stay'}, {'measure': 'ICU stay', 'timeFrame': 'an average of 5 days', 'description': 'Intensive care unit length of stay'}, {'measure': 'ICU readmission', 'timeFrame': 'an average of 30 days', 'description': 'Amount of hospital readmissions'}, {'measure': 'Renal insufficiency - 1', 'timeFrame': 'intensive care unit stay, an average of 5 days', 'description': 'Incidence of renal insufficiency'}, {'measure': 'Renal insufficiency - 2', 'timeFrame': 'intensive care unit stay, an average of 5 days', 'description': 'dialysis duration'}, {'measure': 'Renal insufficiency - 3', 'timeFrame': 'intensive care unit stay, an average of 5 days', 'description': 'Urine production'}, {'measure': 'Stroke', 'timeFrame': 'hospital length of stay, an average of 13 days', 'description': 'incidence of strokes'}, {'measure': 'mortality rate-1', 'timeFrame': '90 days', 'description': 'mortality rate after 90 days'}, {'measure': 'mortality rate-2', 'timeFrame': '180 days', 'description': 'mortality rate after 180 days'}, {'measure': 'mortality rate-3', 'timeFrame': '3 years', 'description': 'mortality rate after 3 years'}, {'measure': 'mortality rate-4', 'timeFrame': '1 year', 'description': 'mortality rate after 1 year'}, {'measure': 'mortality rate-5', 'timeFrame': '5 years', 'description': 'mortality rate after 5 years'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Central Venous Pressure']}, 'descriptionModule': {'briefSummary': 'Recent studies indicated the central venous pressure (CVP) as a prognostic marker. Therefore, we retrospectively analyzed the CVP on admission to the intensive care unit (ICU) in cardiac surgery patients regarding its prognostic value for morbidity and mortality.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'All adult male and female patients who have undergone cardiac surgery in the period 01/06-12/13 at Campus Mitte in the Charité, approx. 7000 patients.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* In-patients of the Charité Universitätsmedizin Berlin\n* at least 18 years old\n* female or male sex\n* cardiosurgical intervention (OPS 5.35 and 5.36) between 01/06 and 12/13.\n* post-operative monitoring of anesthesiological intensive care unit\n\nExclusion Criteria:\n\n* previous cardiosurgical interventions during the same hospital stay.\n* incomplete documentation'}, 'identificationModule': {'nctId': 'NCT03423420', 'briefTitle': 'Pontos-Central Venous Pressure and Cardiac Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Charite University, Berlin, Germany'}, 'officialTitle': 'High Central Venous Pressure After Cardiac Surgery is Associated With Increased Morbidity and Mortality', 'orgStudyIdInfo': {'id': 'PONTOS-CVP'}}, 'contactsLocationsModule': {'locations': [{'zip': '10117', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Charité - Universitaetsmedizin Berlin', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}], 'overallOfficials': [{'name': 'Felix Balzer, MD, MSc, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Charite Universitätsmedizin Berlin'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Charite University, Berlin, Germany', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof. Dr. med. Dr. rer. nat., MSc', 'investigatorFullName': 'Felix Balzer', 'investigatorAffiliation': 'Charite University, Berlin, Germany'}}}}