Ignite Creation Date:
2025-12-25 @ 3:18 AM
Ignite Modification Date:
2025-12-31 @ 4:54 PM
Study NCT ID:
NCT06697405
Status:
RECRUITING
Last Update Posted:
2024-12-27
First Post:
2024-11-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Cardiopulmonary Bypass Time on Gastrointestinal Complications
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1600}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-12-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-24', 'studyFirstSubmitDate': '2024-11-16', 'studyFirstSubmitQcDate': '2024-11-18', 'lastUpdatePostDateStruct': {'date': '2024-12-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-11-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The acute gastrointestinal injury (AGI) score', 'timeFrame': '1 month', 'description': 'The AGI score of the patient within the seventh postoperative day was performed daily according to the European Society of critical care (2012) guidelines for AGI. Determined the severity with grade 1-4,The higher the score, the more serious it is.'}], 'secondaryOutcomes': [{'measure': 'Return Time of Bowel Sounds', 'timeFrame': '1 month', 'description': 'The time to first detection of bowel sounds after surgery, monitored daily in the morning and evening by auscultation.'}, {'measure': 'Frequency of Bowel Sounds', 'timeFrame': '1 month', 'description': 'The number of bowel sounds counted at 12-hour intervals, recorded twice daily to assess gastrointestinal motility.'}, {'measure': 'Time to First Defecation', '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': 'Analysis of bacterial composition in the first stool sample post-surgery, focusing on the ratio of cocci to bacilli.'}, {'measure': '5.C-Reactive Protein (CRP)', 'timeFrame': '1 month', 'description': 'Maximum CRP level recorded within the first week after surgery.'}, {'measure': 'Procalcitonin (PCT)', 'timeFrame': '1 month', 'description': 'Maximum PCT level recorded within the first week after surgery.'}, {'measure': 'Alanine Aminotransferase (ALT)', 'timeFrame': '1 month', 'description': 'The investigators defined it as the maximum value of ALT within 7 days after surgery.'}, {'measure': 'Aspartate Aminotransferase (AST)', 'timeFrame': '1 month', 'description': 'The investigators defined it as the maximum value of ALT within 7 days after surgery.'}, {'measure': 'Creatinine', 'timeFrame': '1 month', 'description': 'The investigators defined it as the maximum value of Creatinine within 7 days after surgery.'}, {'measure': 'Left Ventricular Ejection Fraction (LVEF)', 'timeFrame': '1 month', 'description': 'LVEF assessed through echocardiography on days 1 and 3 post-surgery to monitor cardiac function.'}, {'measure': 'Ventilator assisted time (VAT)', 'timeFrame': '1 month', 'description': 'VAT was defined as the sum time of ventilator assisted post-surgery.'}, {'measure': 'Days of ICU stay', 'timeFrame': '3 months', 'description': 'Total number of days during ICU, reflecting overall recovery and the impact of any gastrointestinal or systemic complications.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cardiopulmonary bypass', 'Gastrointestinal injury', 'Valvular disease', 'Complications'], 'conditions': ['Valvular Disease']}, 'referencesModule': {'references': [{'pmid': '32855033', 'type': 'BACKGROUND', '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': '32772778', 'type': 'BACKGROUND', 'citation': 'Seilitz J, Edstrom M, Skoldberg M, Westerling-Andersson K, Kasim A, Renberg A, Jansson K, Friberg O, Axelsson B, Nilsson KF. Early Onset of Postoperative Gastrointestinal Dysfunction Is Associated With Unfavorable Outcome in Cardiac Surgery: A Prospective Observational Study. J Intensive Care Med. 2021 Nov;36(11):1264-1271. doi: 10.1177/0885066620946006. Epub 2020 Aug 10.'}, {'pmid': '22310869', 'type': 'BACKGROUND', 'citation': 'Reintam Blaser A, Malbrain ML, Starkopf J, Fruhwald S, Jakob SM, De Waele J, Braun JP, Poeze M, Spies C. Gastrointestinal function in intensive care patients: terminology, definitions and management. Recommendations of the ESICM Working Group on Abdominal Problems. Intensive Care Med. 2012 Mar;38(3):384-94. doi: 10.1007/s00134-011-2459-y. Epub 2012 Feb 7.'}, {'pmid': '40234981', 'type': 'DERIVED', 'citation': 'Yang X, Lu N, Yang L, Li B, Zhou W, Li Y, Song B, Yuan J, Meng W. Impact of prolonged cardiopulmonary bypass on gastrointestinal complications in cardiac surgery: a retrospective cohort study. Perioper Med (Lond). 2025 Apr 15;14(1):42. doi: 10.1186/s13741-025-00524-w.'}]}, 'descriptionModule': {'briefSummary': 'This retrospective study investigates the relationship between cardiopulmonary bypass (CPB) duration and the incidence of gastrointestinal complications (GICs) in patients undergoing heart valve replacement. Patients will be grouped into a normal CPB group (CPB \\<120 minutes) and a prolonged CPB group (CPB ≥120 minutes). The study aims to determine whether prolonged CPB time is associated with a higher risk of GICs and to evaluate the outcomes and recovery process for patients who develop GICs postoperatively.', 'detailedDescription': 'Heart valve replacement with CPB carries a risk of GICs due to potential ischemia-reperfusion injury to the gastrointestinal tract. GICs in the postoperative period can lead to increased morbidity and prolong recovery. Prolonged CPB time may serve as a predictive factor for the development of GICs following heart valve replacement. This study will utilize established diagnostic criteria to define GICs, which include clinical symptoms, laboratory tests, and imaging as necessary, based on standards from critical care and gastrointestinal surgery guidelines. By understanding this correlation, the study aims to reduce the incidence and severity of postoperative GICs and improve surgical outcomes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients undergoing heart valve replacement with differ CPB durations.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients undergoing heart valve replacement with CPB\n* Age ≥ 18 years and ≤ 75 years\n\nExclusion Criteria:\n\n* Have received major gastrointestinal surgery within 5 years.\n* History of severe infection (e.g., pneumonia, urinary tract infection) requiring hospitalization within 1 month prior to surgery.\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 intraoperatively or within 24 hours postoperatively.\n* Patients with digestive system tumors.\n* Pregnancy or breastfeeding could affect postoperative medication use and study observations.\n* Involvement in other studies that may interfere with the objective results of this study."}, 'identificationModule': {'nctId': 'NCT06697405', 'briefTitle': 'Impact of Cardiopulmonary Bypass Time on Gastrointestinal Complications', 'organization': {'class': 'OTHER', 'fullName': 'Hepatopancreatobiliary Surgery Institute of Gansu Province'}, 'officialTitle': 'Incidence, Risk Factors, and Outcomes of Gastrointestinal Complications in Patients Undergoing Heart Valve Replacement With Cardiopulmonary Bypass', 'orgStudyIdInfo': {'id': 'CPB-GICs'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'CPB time ≥ 120 minutes', 'description': 'Patients will be grouped into a prolonged CPB group (CPB ≥120 minutes)', 'interventionNames': ['Other: Prolonged ≥ 120 minutes']}, {'label': 'CPB time < 120 minutes', 'description': 'Patients will be grouped into a normal CPB group (CPB \\<120 minutes) .', 'interventionNames': ['Other: Prolonged ≥ 120 minutes']}], 'interventions': [{'name': 'Prolonged ≥ 120 minutes', 'type': 'OTHER', 'description': 'No intervention, regular therapy', 'armGroupLabels': ['CPB time < 120 minutes', 'CPB time ≥ 120 minutes']}]}, 'contactsLocationsModule': {'locations': [{'zip': '730000', 'city': 'Lanzhou', 'state': 'Gansu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xiaofang Yang, MD,PhD', 'role': 'CONTACT', 'email': 'Yangxf20@lzu.edu.cn', 'phone': '+8613893167522'}, {'name': 'Wenbo Meng, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hepatopancreatobiliary Surgery Institute of Gansu Province', 'geoPoint': {'lat': 36.05701, 'lon': 103.83987}}], 'centralContacts': [{'name': 'Wenbo Meng', 'role': 'CONTACT', 'email': 'mengwb@lzu.edu.cn', 'phone': '13919177177'}], 'overallOfficials': [{'name': 'Wenbo Meng', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hepatopancreatobiliary Surgery Institute of Gansu Province'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hepatopancreatobiliary Surgery Institute of Gansu Province', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of Surgery', 'investigatorFullName': 'Wenbo Meng', 'investigatorAffiliation': 'Hepatopancreatobiliary Surgery Institute of Gansu Province'}}}}