Ignite Creation Date:
2025-12-25 @ 12:22 AM
Ignite Modification Date:
2025-12-25 @ 10:26 PM
Study NCT ID:
NCT06907758
Status:
RECRUITING
Last Update Posted:
2025-04-02
First Post:
2025-03-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Impact of Perioperative Organ Resuscitation of Brain-dead Deceased Organ Donor on Kidney Graft Function in the Recipient
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-04-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2025-12-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-26', 'studyFirstSubmitDate': '2025-03-26', 'studyFirstSubmitQcDate': '2025-03-26', 'lastUpdatePostDateStruct': {'date': '2025-04-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ratio of creatinine decrease', 'timeFrame': 'Days 1 and 2 in kidney transplant recipients', 'description': 'Ratio of creatinine decrease on days 1 and 2 in kidney transplant recipients (formula: CRR2% = ((Cr1-Cr2)\\*100)/Cr1) or the need for dialysis before day 2.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Kidney Graft', 'Grafts', 'Organ transplantation'], 'conditions': ['Kidney Graft']}, 'descriptionModule': {'briefSummary': 'Brain-dead patients are the primary source of grafts for those awaiting organ transplantation. Recommendations exist for the management of these potential donors, based on the concept of organ resuscitation, according to which targeted resuscitation would improve graft quality and quantity.\n\nGraft performance thus depends on fixed factors (donor/recipient age, medical history, etc.) but also potentially modifiable factors.\n\nThrough this study, the investigators aim to identify potentially modifiable factors in our donor care (in intensive care and the operating room) that may influence graft function in the recipient. For simplicity, the investigators will focus on kidney grafts. The aim is to improve the effectiveness of the transplant and reduce waiting times.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Subject adulte', 'eligibilityCriteria': "Inclusion Criteria:\n\nThe inclusion criteria for organ donor patients are as follows:\n\n* Adult patient\n* Brain dead\n* Hospitalized in surgical intensive care at Strasbourg University Hospital (NHC cardiovascular intensive care unit, NHC multi-purpose intensive care unit, Hautepierre surgical intensive care unit) from January 1, 2018 to December 31, 2023\n* Having undergone multi-organ transplantation\n* At least one of the donor kidneys has been transplanted to a patient at Strasbourg University Hospital\n* Absence of written objection in the medical file of the subject (and/or their legal representative, if applicable) to the reuse of their data for scientific research purposes.\n\nThe inclusion criteria for kidney transplant recipients are as follows:\n\n* Adult patient\n* Recipient of a kidney transplant from an organ donor who meets the inclusion criteria for donor patients mentioned above\n* Patient who has undergone surgery and is hospitalized post-operatively at Strasbourg University Hospital\n* Patient monitored by the Strasbourg University Hospital transplant team\n* Absence of written objection in the subject's medical file (and/or their legal representative, if applicable) to the reuse of their data for scientific research purposes.\n\nExclusion Criteria:\n\n* Subject (and/or their legal representative, if applicable) who has expressed their opposition to the reuse of their data for scientific research purposes\n* Brain-dead patient who has not undergone organ retrieval\n* Brain-dead patient whose kidney has not been allocated to a recipient in Strasbourg\n* Patient transferred to the Strasbourg University Hospital's intensive care unit from another hospital in a state of already diagnosed brain death solely for organ retrieval\n* Kidney transplant patient with a graft from a living donor\n* Kidney transplant patient with a graft from a deceased donor who is not brain-dead\n* Kidney transplant patient with a graft from a deceased donor who is brain-dead and hospitalized in a hospital other than Strasbourg"}, 'identificationModule': {'nctId': 'NCT06907758', 'acronym': 'OPTI-PMO 2', 'briefTitle': 'Impact of Perioperative Organ Resuscitation of Brain-dead Deceased Organ Donor on Kidney Graft Function in the Recipient', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Strasbourg, France'}, 'officialTitle': 'Impact of Perioperative Organ Resuscitation of Brain-dead Deceased Organ Donor on Kidney Graft Function in the Recipient', 'orgStudyIdInfo': {'id': '9245'}}, 'contactsLocationsModule': {'locations': [{'zip': '67091', 'city': 'Strasbourg', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Charlotte POUSSARDIN, MD', 'role': 'CONTACT', 'email': 'charlotte.poussardin@chru-strasbourg.fr', 'phone': '33.3.69.55.16.21'}, {'name': 'Charlotte POUSSARDIN, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Quentin GISSELBRECHT, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Benjamin Lebas, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Cédric Fuchs, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Julien Godet, Statician', 'role': 'SUB_INVESTIGATOR'}], 'facility': "Service d'Anesthésie, Réanimation et Médecine Périopératoire - CHU de Strasbourg - France", 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}], 'centralContacts': [{'name': 'Charlotte POUSSARDIN, MD', 'role': 'CONTACT', 'email': 'charlotte.poussardin@chru-strasbourg.fr', 'phone': '33.3.69.55.16.21'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Strasbourg, France', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}