Ignite Creation Date:
2025-12-24 @ 10:10 PM
Ignite Modification Date:
2025-12-25 @ 7:45 PM
Study NCT ID:
NCT05498935
Status:
COMPLETED
Last Update Posted:
2024-01-03
First Post:
2022-08-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Prolonged Cardiopulmonary Bypass Time as a Predictive Factor for AGI After Heart Valve Replacement
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006349', 'term': 'Heart Valve Diseases'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1070}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-08-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2024-01-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-01-02', 'studyFirstSubmitDate': '2022-08-10', 'studyFirstSubmitQcDate': '2022-08-10', 'lastUpdatePostDateStruct': {'date': '2024-01-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-08-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cardiopulmonary bypass (CPB) time', 'timeFrame': '1 month', 'description': 'Was defined it as the sum of times of CPB during surgery (minutes).'}, {'measure': 'The AGI score', 'timeFrame': '1 month', 'description': 'The AGI score of the patient within the seventh postoperative day was performed according to the European Society of critical care (2012) guidelines for AGI.'}], 'secondaryOutcomes': [{'measure': 'Number of bowel sounds', 'timeFrame': '1 month', 'description': 'The return time of bowel sounds was evaluated morning and evening.'}, {'measure': 'First defecation time', 'timeFrame': '1 month', 'description': 'The time to the first defecation was asked morning and evening after surgery'}, {'measure': 'Proportion of cocci and bacilli in feces', 'timeFrame': '1 month', 'description': 'The first feces were collected in sterile containers for the bacterial smear'}, {'measure': 'Alanine aminotransferase (ALT)', 'timeFrame': '1 month', 'description': 'We defined it as the maximum value of ALT within 7 days after surgery.'}, {'measure': 'Aspartate aminotransferase (AST)', 'timeFrame': '1 month', 'description': 'We defined it as the maximum value of AST within 7 days after surgery'}, {'measure': 'Left ventricular ejection fraction (LVEF)', 'timeFrame': '1 month', 'description': 'We measured the LVEF on the 1st and 3rd days after operation by echocardiographic examinations'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Heart valve diseases', 'Gastrointestinal tract'], 'conditions': ['Heart Valve Diseases']}, 'referencesModule': {'references': [{'pmid': '32855033', 'type': 'RESULT', 'citation': 'Gallitto E, Sobocinski J, Mascoli C, Pini R, Fenelli C, Faggioli G, Haulon S, Gargiulo M. Fenestrated and Branched Thoraco-abdominal Endografting after Previous Open Abdominal Aortic Repair. Eur J Vasc Endovasc Surg. 2020 Dec;60(6):843-852. doi: 10.1016/j.ejvs.2020.07.071. Epub 2020 Aug 24.'}, {'pmid': '8494005', 'type': 'RESULT', 'citation': 'Buchbinder A, Adler H, Ballard H. An unusual and unreported toxicity to erythropoietin. Am J Hematol. 1993 Apr;42(4):412-3. doi: 10.1002/ajh.2830420428. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'In this retrospective study, the investigators will analyze the correlation between cardiopulmonary bypass (CPB) time and acute gastrointestinal injury (AGI), and the outcomes of AGI in patients undergoing heart valve replacement.', 'detailedDescription': 'Patients with heart valve diseases often have chronic cardiac insufficiency. Patients undergoing heart valve replacement with CPB are always complicated with gastrointestinal tract ischemia-reperfusion injury, which usually leads to AGI. AGI after cardiovascular surgery, especially in that use CPB, is associated with significant morbidity and an increase in peri-operative mortality. Prolonged CPB time could be predictive of AGI following heart valve replacement. This study is to analyze the correlation between CPB time and AGI, and the outcomes of AGI in patients undergoing heart valve replacement. The investigators hope that the benefits will include fewer patients becoming seriously postoperative AGI and mortality after cardiac surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Heart valve diseases', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients undergoing heart valve replacement surgery with CPB\n* Age \\> 18 years and ≤ 70 years\n\nExclusion Criteria:\n\n* Patients combined with severe hematological disease, respiratory disease, and other critical diseases\n* Patients had severe disorder of multiple systems and organs or severe pulmonary hypertension\n* Have received major gastrointestinal surgery within 5 years\n* Inflammatory bowel disease (IBD), including ulcerative colitis, Crohn's disease, or colitis\n* Acute gastroenteritis\n* Clostridium difficile or Helicobacter pylori infection\n* Chronic constipation\n* Peptic ulcer\n* Polyps in the stomach or intestines\n* Gastrointestinal neoplasms\n* Abdominal hernia\n* Irritable bowel syndrome\n* Acute or chronic cholecystitis, hepatitis\n* Patients who died during surgery\n* Patients with digestive system tumors"}, 'identificationModule': {'nctId': 'NCT05498935', 'briefTitle': 'Prolonged Cardiopulmonary Bypass Time as a Predictive Factor for AGI After Heart Valve Replacement', 'organization': {'class': 'OTHER', 'fullName': 'Hepatopancreatobiliary Surgery Institute of Gansu Province'}, 'officialTitle': 'Prolonged Cardiopulmonary Bypass (CPB) Time as a Predictive Factor for Acute Gastrointestinal Injury (AGI) After Heart Valve Replacement', 'orgStudyIdInfo': {'id': 'CPB-AGI'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'CPB time ≥ 90 minutes', 'description': 'No intervention, regular therapy', 'interventionNames': ['Other: CPB time']}, {'label': 'CPB time < 90 minutes', 'description': 'No intervention, regular therapy', 'interventionNames': ['Other: CPB time']}], 'interventions': [{'name': 'CPB time', 'type': 'OTHER', 'description': 'Cardiopulmonary bypass time', 'armGroupLabels': ['CPB time < 90 minutes', 'CPB time ≥ 90 minutes']}]}, 'contactsLocationsModule': {'locations': [{'zip': '730000', 'city': 'Lanzhou', 'state': 'Gansu', 'country': 'China', 'facility': 'Hepatopancreatobiliary Surgery Institute of Gansu Province', 'geoPoint': {'lat': 36.05701, 'lon': 103.83987}}], 'overallOfficials': [{'name': 'Wenbo Meng, M.D. Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'LanZhou University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'If patients permitted'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hepatopancreatobiliary Surgery Institute of Gansu Province', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Surgery', 'investigatorFullName': 'Wenbo Meng', 'investigatorAffiliation': 'Hepatopancreatobiliary Surgery Institute of Gansu Province'}}}}