Ignite Creation Date:
2025-12-24 @ 2:04 PM
Ignite Modification Date:
2026-03-28 @ 12:08 AM
Study NCT ID:
NCT02613195
Status:
UNKNOWN
Last Update Posted:
2015-11-24
First Post:
2015-10-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Trial of Hydrogen-Rich Celsior Solution Applied in Aging DBD Liver/Kidney Transplantation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015427', 'term': 'Reperfusion Injury'}], 'ancestors': [{'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': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2016-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-10', 'completionDateStruct': {'date': '2017-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-11-20', 'studyFirstSubmitDate': '2015-10-24', 'studyFirstSubmitQcDate': '2015-11-20', 'lastUpdatePostDateStruct': {'date': '2015-11-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-11-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Aspartate Aminotransferase(AST)/Alanine Aminotransferase(ALT)', 'timeFrame': 'up to 6 months'}, {'measure': 'Change From Baseline in direct bilirubin(DBil)/total bilirubin(TBil)', 'timeFrame': 'up to 6 months'}, {'measure': 'Change From Baseline in creatinine', 'timeFrame': 'up to 6 months'}, {'measure': 'Change From Baseline in glomerular filtration rate（GFR）', 'timeFrame': 'up to 6 months'}], 'secondaryOutcomes': [{'measure': 'Pathological score of liver/kidney preservation injury during surgery', 'timeFrame': 'during surgery'}, {'measure': 'Mitochondrial function index of hepatocyte/nephrocyte during surgery', 'timeFrame': 'during surgery'}, {'measure': 'The total incidence of adverse events/incidence of severe adverse events', 'timeFrame': 'up to 6 months'}, {'measure': 'postoperative complications', 'timeFrame': 'up to 6 months'}, {'measure': 'Early graft function incidence', 'timeFrame': 'baseline and 6 months'}, {'measure': 'Graft dysfunction incidence', 'timeFrame': 'baseline and 6 months'}, {'measure': 'Recipient survival', 'timeFrame': 'baseline and 6 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Ischemia-Reperfusion Injury', 'oxidative stress', 'organ preservation', 'Hydrogen', 'Kidney Transplantation'], 'conditions': ['Evidence of Liver Transplantation']}, 'referencesModule': {'references': [{'pmid': '22683850', 'type': 'RESULT', 'citation': 'Abe T, Li XK, Yazawa K, Hatayama N, Xie L, Sato B, Kakuta Y, Tsutahara K, Okumi M, Tsuda H, Kaimori JY, Isaka Y, Natori M, Takahara S, Nonomura N. Hydrogen-rich University of Wisconsin solution attenuates renal cold ischemia-reperfusion injury. Transplantation. 2012 Jul 15;94(1):14-21. doi: 10.1097/TP.0b013e318255f8be.'}, {'pmid': '23742028', 'type': 'RESULT', 'citation': 'Qian L, Shen J. Hydrogen therapy may be an effective and specific novel treatment for acute graft-versus-host disease (GVHD). J Cell Mol Med. 2013 Aug;17(8):1059-63. doi: 10.1111/jcmm.12081. Epub 2013 Jun 7.'}, {'pmid': '21956195', 'type': 'RESULT', 'citation': 'Buchholz BM, Masutani K, Kawamura T, Peng X, Toyoda Y, Billiar TR, Bauer AJ, Nakao A. Hydrogen-enriched preservation protects the isogeneic intestinal graft and amends recipient gastric function during transplantation. Transplantation. 2011 Nov 15;92(9):985-92. doi: 10.1097/TP.0b013e318230159d.'}, {'pmid': '24410860', 'type': 'RESULT', 'citation': 'Liu Y, Yang L, Tao K, Vizcaychipi MP, Lloyd DM, Sun X, Irwin MG, Ma D, Yu W. Protective effects of hydrogen enriched saline on liver ischemia reperfusion injury by reducing oxidative stress and HMGB1 release. BMC Gastroenterol. 2014 Jan 12;14:12. doi: 10.1186/1471-230X-14-12.'}, {'pmid': '25121557', 'type': 'RESULT', 'citation': "Noda K, Shigemura N, Tanaka Y, Bhama J, D'Cunha J, Kobayashi H, Luketich JD, Bermudez CA. Hydrogen preconditioning during ex vivo lung perfusion improves the quality of lung grafts in rats. Transplantation. 2014 Sep 15;98(5):499-506. doi: 10.1097/TP.0000000000000254."}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate whether hydrogen-rich Celsior solution improve the quality of aging grafts in liver/kidney transplantation.', 'detailedDescription': 'The organ shortage has been rising to impede the development of organ transplantation.To find a solution, transplantation center is working on the application of marginal grafted liver or renal, especially the aging grafts. The most common inducement of organ dysfunction during the perioperation is liver/renal ischemia-reperfusion (I/R) injury, caused by the generation of cytotoxic oxygen radicals. Hydrogen gas is a kind of reducing gas, which has been reported to display antioxidant properties and protective effects against organ dysfunction induced by various I/R injuries. Investigators will investigate whether hydrogen-rich Celsior solution improve the quality of aging grafts in liver/ kidney transplantation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\nDonors:\n\n1. Age of the donor ≥60 yrs.\n2. The donor has no historical records of drug abuse, alcoholic abuse, homosexual,or drug addiction, etc.\n3. Evaluate infections and infectious disease of the donor.\n4. History of malignant tumor;\n5. History of hypertension, diabetes, hemophilia, or other anticoagulant disease,kidney donor should not have a history of kidney disease.\n6. Daily urine volume is approximately normal.\n7. Donor should be subjected to physical examination by medical doctor of OPO stuff before donation; the OPO stuff should realize whether the potential donor has infected lesion or not, such as abscess, ulcer, lymphadenectasis， etc., and evaluate infectious risk of recipient post-operationally.\n8. OPO stuff should realize the dynamic change of body temperature, as well as various intensive care parameters of the potential donor, it shall be very important to be sure whether the potential donor has pulmonary/ systemic infections or not,especially for whom has longer ICU duration (\\> 7 Days).\n9. The potential donor should has a systolic blood pressure ≥ 50 mm Hg (1mmHg=0.133 kPa) and arterial SaO \\> 80%.\n10. Liver Biochemistry: alanine aminotransferase (ALT) ≤ 6ULN, total bilirubin (TBil) ≤ 50umol/L;Kidney Biochemistry: serum creatinine (sCre) ≤ 2ULN;\n11. Negative anti-HIV antibody;\n12. Negative bacterial and fungal culture in blood;\n13. Ultrasonic diagnosis of fatty liver, trauma, hematoma, lithiasis, etc., as well as size of both kidney, hydronephrosis, nephrolithiasis, etc. if possible.\n14. Graft liver should be soft, normal color and even, no tumor or other abnormity;steatosis ≤ 30% by liver biopsy.Graft kidneys should have complete renal capsule with no congestion or bleeding;proximal tubular necrosis ≤ 50%, without obvious structural damage.Organ (liver and kidney) cold ischemia time (CIT) is determined as the time duration from cold preservation of organs to transplant re-perfusion. CIT of aging DBD liver and kidney graft should be ≤ 10 and16 hours, respectively.\n\nRecipients：\n\n1. Aged between 18-65 years old\n2. MELD score ≤25,BMI≤25\n3. Patients with tumor,the expected lifetime≥6 months\n4. Agree to anticipate the trial and sign the informed consent\n\nExclusion Criteria:\n\n* Donor's age \\< 60 yrs;\n* The donor has historical records of drug abuse, alcoholic abuse, homosexual, or drug addiction, etc.\n* The donor is HIV infected, or has severe infection, or positive bacterial and/ or fungal culture results;\n* Uncontrollable hypertension, diabetics;\n* Malignant tumor;\n* Unstable hemodynamic response or SaO status, such as systolic pressure \\<50 mm Hg (1mmHg=0.133 kPa) , or arterial SaO\\<80%.\n* Liver Biochemistry: alanine aminotransferase (ALT)\\>6ULN, total bilirubin (TBil)\\>50umol/L;\n* Graft liver has a steatosis \\>30%, or graft kidney has a proximal tubular necrosis\\>50% or obvious glomerular sclerosis."}, 'identificationModule': {'nctId': 'NCT02613195', 'acronym': 'HRCSDBD', 'briefTitle': 'Clinical Trial of Hydrogen-Rich Celsior Solution Applied in Aging DBD Liver/Kidney Transplantation', 'organization': {'class': 'OTHER', 'fullName': 'RenJi Hospital'}, 'officialTitle': 'Hydrogen-Rich Celsior Solution Improve the Quality of Aging DBD Grafts in Liver/Kidney Transplantation: Prospective, Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'RenJiH-20151020'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Hydrogen-rich Celsior solution', 'description': 'Using aging liver grafts（≥60 years old)，lavaged and cold stored with hydrogen-rich Celsior solution for 2-4 hours.', 'interventionNames': ['Drug: Hydrogen-Rich Celsior Solution']}, {'type': 'NO_INTERVENTION', 'label': 'Celsior solution', 'description': 'Using aging liver/kidney grafts（≥60 years old）, lavaged and cold stored with common Celsior solution for 2-4 hours.'}], 'interventions': [{'name': 'Hydrogen-Rich Celsior Solution', 'type': 'DRUG', 'otherNames': ['HR solution'], 'description': 'Before the procedure, add hydrogen gas into Celsior solution. After harvesting the liver/kidney grafts, lavage and cold store the grafts with Hydrogen-Rich Celsior Solution.', 'armGroupLabels': ['Hydrogen-rich Celsior solution']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200127', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'contacts': [{'name': 'Xia Qiang, Investigator', 'role': 'CONTACT', 'email': 'xiaqiang@shsmu.edu.cn', 'phone': '+86-21-68383775'}, {'name': 'Xue Feng, Investigator', 'role': 'CONTACT', 'email': 'fengxue6879@163.com', 'phone': '+8613761267573'}, {'name': 'Xia Qiang, Investigator', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Xue Feng, Investigator', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Shi Shaojun', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Ren Ji Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '200127', 'city': 'Shanghai', 'country': 'China', 'facility': 'Deparment of Liver Surgery, Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Xia Qiang, investigator', 'role': 'CONTACT', 'email': 'xiaqiang@shsmu.edu.cn', 'phone': '+86-21-68383775'}, {'name': 'Xue Feng, investigator', 'role': 'CONTACT', 'email': 'fengxue6879@163.com', 'phone': '+8613761267573'}], 'overallOfficials': [{'name': 'Xia Qiang, investigator', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Deparment of Liver Surgery'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'RenJi Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}