Ignite Creation Date:
2025-12-25 @ 12:01 AM
Ignite Modification Date:
2026-02-23 @ 6:25 AM
Study NCT ID:
NCT06855758
Status:
RECRUITING
Last Update Posted:
2025-03-20
First Post:
2025-02-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Terlipressin for Intraoperative Blood Pressure Management in Kidney Transplantation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051799', 'term': 'Delayed Graft Function'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077585', 'term': 'Terlipressin'}], 'ancestors': [{'id': 'D008236', 'term': 'Lypressin'}, {'id': 'D014667', 'term': 'Vasopressins'}, {'id': 'D010909', 'term': 'Pituitary Hormones, Posterior'}, {'id': 'D010907', 'term': 'Pituitary Hormones'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D009479', 'term': 'Neuropeptides'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D009842', 'term': 'Oligopeptides'}, {'id': 'D009419', 'term': 'Nerve Tissue Proteins'}, {'id': 'D011506', 'term': 'Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-03-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2027-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-17', 'studyFirstSubmitDate': '2025-02-27', 'studyFirstSubmitQcDate': '2025-02-27', 'lastUpdatePostDateStruct': {'date': '2025-03-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Delayed graft function', 'timeFrame': 'within the first 7 days after op', 'description': 'need kidney replacement in the first 7 days after op'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Kidney Transplant', 'Delayed Graft Function', 'Intraoperative Hypotension']}, 'descriptionModule': {'briefSummary': 'Prospective double blind randomized controlled trial. By randomizing patients undergoing kidney transplantation into a conventional catecholamine drug (dobutamine) blood pressure maintenance group and a terlipressin-complexed dobutamine group, the investigators compared the effect of intraoperative blood pressure maintenance and the dosage of the vasoactive drug, postoperative graft function, delayed graft function, and other related complications between the two groups, in order to demonstrate whether the use of terlipressin for blood pressure regulation during kidney transplantation is superior to the existing treatments.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with end-stage renal disease aged 18 years or above\n\nExclusion Criteria:\n\n* simultaneous multiple organ transplantation\n* known allergy to study medication\n* known pregnancy status\n* cancellation of surgery due to grafts or personal reasons\n* persistent severe preoperative hypertension that may not require intraoperative supportive therapy with vasoactive medications\n* any other reason that the supervising physician or the anesthesiologist on duty think the patient is not suitable for the study'}, 'identificationModule': {'nctId': 'NCT06855758', 'briefTitle': 'Effect of Terlipressin for Intraoperative Blood Pressure Management in Kidney Transplantation', 'organization': {'class': 'OTHER', 'fullName': 'Beijing Friendship Hospital'}, 'officialTitle': 'Effect of Terlipressin for Intraoperative Blood Pressure Management in Kidney Transplantation, a Double-blind Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '2025-P2-023-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'dopamine', 'description': 'Continuous using of dopamine as blood pressure regulation after anesthesia, with dosage adjusted according to intraoperative needs'}, {'type': 'EXPERIMENTAL', 'label': 'terlipressin + dopamine', 'description': 'Terlipressin was given before the graft circulation was established while continuous using of dopamine during the whole operation', 'interventionNames': ['Drug: terlipressin']}], 'interventions': [{'name': 'terlipressin', 'type': 'DRUG', 'description': 'Terlipressin was given prior to the opening of the graft circulation (with the possibility of reperfusion hypotension) when the blood pressure is suboptimal and does not respond well to dobutamine or fluid volume resuscitation. 1 mg terlipressin + 100 ml of sodium chloride injections was given for intravenous infusion.', 'armGroupLabels': ['terlipressin + dopamine']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beijing', 'status': 'RECRUITING', 'country': 'China', 'facility': 'Beijing Friendship Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Wenhe Yang', 'role': 'CONTACT', 'email': '13810673664@163.com', 'phone': '86 13810673664'}], 'overallOfficials': [{'name': 'Fushan Xue', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Anesthesiology, Beijing Friendship Hospital'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'timeFrame': 'after published', 'ipdSharing': 'YES', 'description': 'Selected statistics related to outcomes', 'accessCriteria': 'Investigators who submitting research proposals and signing agreements of data using with corresponding authors'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beijing Friendship Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}