Ignite Creation Date:
2025-12-24 @ 2:54 PM
Ignite Modification Date:
2025-12-27 @ 10:31 AM
Study NCT ID:
NCT06395259
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-09-04
First Post:
2024-01-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Observational Study on the Variation of Ascorbic Acid in Patients Undergoing Solid Organ Transplantation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001206', 'term': 'Ascorbic Acid Deficiency'}, {'id': 'D055031', 'term': 'Primary Graft Dysfunction'}], 'ancestors': [{'id': 'D001361', 'term': 'Avitaminosis'}, {'id': 'D003677', 'term': 'Deficiency Diseases'}, {'id': 'D044342', 'term': 'Malnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D015427', 'term': 'Reperfusion Injury'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Whole blood samples are collected (in lithium-heparin tubes), appropriately centrifuged, and the plasma thus obtained is frozen at -80°'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2023-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2024-08-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-09-01', 'studyFirstSubmitDate': '2024-01-24', 'studyFirstSubmitQcDate': '2024-04-29', 'lastUpdatePostDateStruct': {'date': '2024-09-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-05-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-08-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ascorbic Acid levels', 'timeFrame': 'At induction of anesthesia for TX, within 24h from ICU admission, 72 hours after transplantation, 7 days after transplantation', 'description': 'Quantification of plasma ascorbic acid levels before and after liver/kidney/lung transplantation'}], 'secondaryOutcomes': [{'measure': 'Reactive Oxygen Species (ROS) levels', 'timeFrame': 'At induction of anesthesia for TX, within 24 hours from ICU admission, 72 hours after transplantation, 7 days after transplantation', 'description': 'Quantification of ROS before and after liver/kidney/lung transplantation'}, {'measure': 'Total Antioxidant Capacity (TAC) levels', 'timeFrame': 'At induction of anesthesia for TX, within 24 hours from ICU admission, 72 hours after transplantation, 7 days after transplantation', 'description': 'Quantification of TAC before and after liver/kidney/lung transplantation'}, {'measure': '8-hydroxydeoxyguanosine (8-OHdG) levels', 'timeFrame': 'At induction of anesthesia TX, within 24 hours from ICU admission, 72 hours after transplantation, 7 days after transplantation', 'description': 'Quantification of 8-OHdG before and after liver/kidney/lung transplantation'}, {'measure': 'Mechanical ventilation', 'timeFrame': 'From ICU admission until extubation occurs, assessed daily up to 100 days from transplantation', 'description': 'Duration of mechanical ventilation (days) until extubation of the recipient'}, {'measure': 'Length of Intensive Care Unit (ICU) stay', 'timeFrame': 'From ICU admission until ICU discharge occurs, assessed daily up to 100 days from transplantation', 'description': 'Length of ICU stay'}, {'measure': 'Allograft dysfunction', 'timeFrame': 'Within the first 7 days after transplantation', 'description': 'Incidence of early allograft dysfunction (EAD in liver recipients), primary graft dysfunction (PGD in lung recipients), delayed graft function (DGF in kidney recipients)'}, {'measure': 'Mortality in Intensive Care Unit (ICU)', 'timeFrame': 'From ICU admission until ICU discharge occurs, assessed daily up to 100 days from transplantation', 'description': 'Incidence of death for any cause during ICU stay'}, {'measure': 'Length of hospitalization', 'timeFrame': 'From ICU admission until hospital discharge occurs, assessed daily up to 100 days from transplantation', 'description': 'Length of stay in hospital (days)'}, {'measure': 'Acute kidney injury (AKI)', 'timeFrame': 'Worst kidney function within the first 7 days after TX', 'description': 'Incidence of postoperative renal injury after liver/kidney/lung transplantation as Kidney Disease Improving Global Outcomes (KDIGO) criteria'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Transplantation', 'Ascorbic Acid', 'Oxidative Stress', 'Primary Graft Dysfunction'], 'conditions': ['Transplantation', 'Ascorbic Acid Deficiency']}, 'referencesModule': {'references': [{'pmid': '33202744', 'type': 'BACKGROUND', 'citation': 'Fernandez AR, Sanchez-Tarjuelo R, Cravedi P, Ochando J, Lopez-Hoyos M. Review: Ischemia Reperfusion Injury-A Translational Perspective in Organ Transplantation. Int J Mol Sci. 2020 Nov 13;21(22):8549. doi: 10.3390/ijms21228549.'}, {'pmid': '29047088', 'type': 'BACKGROUND', 'citation': 'Pak O, Sydykov A, Kosanovic D, Schermuly RT, Dietrich A, Schroder K, Brandes RP, Gudermann T, Sommer N, Weissmann N. Lung Ischaemia-Reperfusion Injury: The Role of Reactive Oxygen Species. Adv Exp Med Biol. 2017;967:195-225. doi: 10.1007/978-3-319-63245-2_12.'}, {'pmid': '27403232', 'type': 'BACKGROUND', 'citation': 'Shi S, Xue F. Current Antioxidant Treatments in Organ Transplantation. Oxid Med Cell Longev. 2016;2016:8678510. doi: 10.1155/2016/8678510. Epub 2016 Jun 15.'}, {'pmid': '10342331', 'type': 'BACKGROUND', 'citation': 'Williams A, Riise GC, Anderson BA, Kjellstrom C, Schersten H, Kelly FJ. Compromised antioxidant status and persistent oxidative stress in lung transplant recipients. Free Radic Res. 1999 May;30(5):383-93. doi: 10.1080/10715769900300421.'}, {'pmid': '26762627', 'type': 'BACKGROUND', 'citation': 'Kumar S, Sharma U, Sharma A, Kenwar DB, Singh S, Prasad R, Minz M. Evaluation of oxidant and antioxidant status in living donor renal allograft transplant recipients. Mol Cell Biochem. 2016 Feb;413(1-2):1-8. doi: 10.1007/s11010-015-2617-6. Epub 2016 Jan 13.'}, {'pmid': '28574431', 'type': 'BACKGROUND', 'citation': 'Sotomayor CG, Eisenga MF, Gomes Neto AW, Ozyilmaz A, Gans ROB, Jong WHA, Zelle DM, Berger SP, Gaillard CAJM, Navis GJ, Bakker SJ. Vitamin C Depletion and All-Cause Mortality in Renal Transplant Recipients. Nutrients. 2017 Jun 2;9(6):568. doi: 10.3390/nu9060568.'}, {'pmid': '31505814', 'type': 'BACKGROUND', 'citation': 'Hill A, Borgs C, Fitzner C, Stoppe C. Perioperative Vitamin C and E levels in Cardiac Surgery Patients and Their Clinical Significance. Nutrients. 2019 Sep 9;11(9):2157. doi: 10.3390/nu11092157.'}, {'pmid': '33487249', 'type': 'BACKGROUND', 'citation': 'Borran M, Dashti-Khavidaki S, Alamdari A, Naderi N. Vitamin C and kidney transplantation: Nutritional status, potential efficacy, safety, and interactions. Clin Nutr ESPEN. 2021 Feb;41:1-9. doi: 10.1016/j.clnesp.2020.12.017. Epub 2021 Jan 9.'}, {'pmid': '2244489', 'type': 'BACKGROUND', 'citation': 'Frei B, Stocker R, England L, Ames BN. Ascorbate: the most effective antioxidant in human blood plasma. Adv Exp Med Biol. 1990;264:155-63. doi: 10.1007/978-1-4684-5730-8_24.'}, {'pmid': '25185110', 'type': 'BACKGROUND', 'citation': 'Oudemans-van Straaten HM, Spoelstra-de Man AM, de Waard MC. Vitamin C revisited. Crit Care. 2014 Aug 6;18(4):460. doi: 10.1186/s13054-014-0460-x.'}, {'pmid': '29558975', 'type': 'BACKGROUND', 'citation': 'Spoelstra-de Man AME, Elbers PWG, Oudemans-van Straaten HM. Making sense of early high-dose intravenous vitamin C in ischemia/reperfusion injury. Crit Care. 2018 Mar 20;22(1):70. doi: 10.1186/s13054-018-1996-y.'}, {'pmid': '31111241', 'type': 'BACKGROUND', 'citation': 'Wang Y, Lin H, Lin BW, Lin JD. Effects of different ascorbic acid doses on the mortality of critically ill patients: a meta-analysis. Ann Intensive Care. 2019 May 20;9(1):58. doi: 10.1186/s13613-019-0532-9.'}, {'pmid': '35504167', 'type': 'BACKGROUND', 'citation': 'Gori F, Fumagalli J, Lonati C, Caccialanza R, Zanella A, Grasselli G. Ascorbic acid in solid organ transplantation: A literature review. Clin Nutr. 2022 Jun;41(6):1244-1255. doi: 10.1016/j.clnu.2022.04.004. Epub 2022 Apr 12.'}]}, 'descriptionModule': {'briefSummary': "The objective of this observational clinical study is to evaluate the variations in ascorbic acid during the transplantation phases and how these variations influence the oxidative status and patient outcome.\n\nThe main questions it aims to answer are:\n\n* how many patients arrive at the transplant in a state of hypovitaminosis C?\n* how does hypovitaminosis C affect the patient's oxidative status?\n* how does hypovitaminosis C affect the length of stay in intensive care and post-transplant complications?", 'detailedDescription': 'Researches will compared:\n\nDifferences between Hypovitaminosis Group and Normal Range Group Changes in oxidative stress markers before and after solid organ transplantation Incidence of allograft dysfunction between groups Incidence of acute kidney injury and other complications between groups'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients undergoing liver, lungs or kidneys transplantation at Ospedale Maggiore in Milan. There is no control group', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients undergoing solid organ transplantation (liver or kidney or lung)\n\nExclusion Criteria:\n\n* Minor patients\n* Multi-organ transplantation'}, 'identificationModule': {'nctId': 'NCT06395259', 'acronym': 'REDOX-TX', 'briefTitle': 'Observational Study on the Variation of Ascorbic Acid in Patients Undergoing Solid Organ Transplantation', 'organization': {'class': 'OTHER', 'fullName': 'Policlinico Hospital'}, 'officialTitle': 'Evaluation of the Oxidative Status of Patients Undergoing Solid Organs Transplantation: Observational Study', 'orgStudyIdInfo': {'id': '3334'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Hypovitaminosis Group', 'description': 'Patients who at the end of surgery have sub-optimal plasma ascorbic acid levels, i.e. with concentrations lower than 28 µmol/L'}, {'label': 'Normal Range Group', 'description': 'Patients who at the end of surgery have plasma ascorbic acid levels equal to or greater than 28 µmol/L'}]}, 'contactsLocationsModule': {'locations': [{'zip': '20122', 'city': 'Milan', 'country': 'Italy', 'facility': "Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico di Milano", 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Policlinico Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Giacomo Grasselli', 'investigatorAffiliation': 'University of Milan'}}}}