Ignite Creation Date:
2025-12-26 @ 10:58 AM
Ignite Modification Date:
2026-02-26 @ 8:11 PM
Study NCT ID:
NCT02901808
Status:
UNKNOWN
Last Update Posted:
2017-10-04
First Post:
2016-08-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Registeranalysis for the Examination of NOMI
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D065666', 'term': 'Mesenteric Ischemia'}], 'ancestors': [{'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010532', 'term': 'Peritoneal Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2008-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-10', 'completionDateStruct': {'date': '2017-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-10-03', 'studyFirstSubmitDate': '2016-08-18', 'studyFirstSubmitQcDate': '2016-09-09', 'lastUpdatePostDateStruct': {'date': '2017-10-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-09-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Development of NOMI', 'timeFrame': 'at the day of surgery, day zero', 'description': 'Clinical signs of NOMI'}], 'secondaryOutcomes': [{'measure': 'Length of stay', 'timeFrame': 'at the day of surgery, day zero up to 365 days', 'description': 'Length of stay will be measured upon the time spent on intensive care unit and in the hospital'}, {'measure': 'Mechanical ventilation', 'timeFrame': 'at the day of surgery, day zero up to 365 days', 'description': 'Length of mechanical ventilation will be measured upon the time spent on intensive care unit'}, {'measure': 'Mortality', 'timeFrame': 'at the day of surgery, day zero up to 365 days', 'description': 'Mortality will be measured upon patients leaving the hospital dead or alive.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['NOMI', 'Angiography', 'Digital Subtraction Angiography (DSA)'], 'conditions': ['Mesenteric Ischemia']}, 'descriptionModule': {'briefSummary': 'The registry includes patients undergoing cardiovascular and thoracic surgery at the Saarland University Medical Center, Homburg/Saar, Germany. This study is a monocentric, retrospective study investigating the development of NOMI and outcome of patients.', 'detailedDescription': 'All data were acquired from the hospital electronic health record and the picture archiving computer system (PACS).\n\nNOMI was suspected if the following clinical signs occured:\n\nnew onset of oliguria (urine output \\<0.5 mL/kg/hour for at least 6 hours) or anuria, abdominal distention with decreased or absent bowel sounds, elevated serum lactate levels \\>5.0mmol/L or metabolic acidosis (base excess \\<-5mmol/L).\n\nIn accordance to the definition of cardiogenic shock angiography was performed in patients with a systolic blood pressure \\>90 mmHg and a cardiac index \\>1.8 L/minute/m².'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Cardio-thoracic surgical patients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The investigators include anonymous data from patients with cardio-thoracic surgery\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT02901808', 'acronym': 'IRRE NOMI', 'briefTitle': 'Registeranalysis for the Examination of NOMI', 'organization': {'class': 'OTHER', 'fullName': 'Universität des Saarlandes'}, 'officialTitle': 'Interdisciplinary Retrospective Registeranalysis for the Examination of Non-occlusive Mesenteric Ischemia (NOMI)', 'orgStudyIdInfo': {'id': '209/15'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'NOMI', 'description': 'Patients suffering from NOMI'}, {'label': 'No-NOMI', 'description': 'Patients not suffering from NOMI'}]}, 'contactsLocationsModule': {'locations': [{'zip': '66421', 'city': 'Homburg', 'state': 'Saarland', 'country': 'Germany', 'facility': 'Saarland University Medical Center', 'geoPoint': {'lat': 49.32637, 'lon': 7.33867}}], 'overallOfficials': [{'name': 'Arno Buecker, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Department of Diagnostic and Interventional Radiology'}, {'name': 'Hans-Joachim Schäfers, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Department of Thoracic and Cardiovascular Surgery'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universität des Saarlandes', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Medical Director', 'investigatorFullName': 'Peter Minko', 'investigatorAffiliation': 'Universität des Saarlandes'}}}}