Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to investigate whether hydrogen-rich Celsior solution improve the quality of aging grafts in liver/kidney transplantation.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hydrogen-rich Celsior solution | Experimental | Using aging liver grafts(≥60 years old),lavaged and cold stored with hydrogen-rich Celsior solution for 2-4 hours. |
|
| Celsior solution | No Intervention | Using aging liver/kidney grafts(≥60 years old), lavaged and cold stored with common Celsior solution for 2-4 hours. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hydrogen-Rich Celsior Solution | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Aspartate Aminotransferase(AST)/Alanine Aminotransferase(ALT) | up to 6 months | |
| Change From Baseline in direct bilirubin(DBil)/total bilirubin(TBil) | up to 6 months | |
| Change From Baseline in creatinine | up to 6 months | |
| Change From Baseline in glomerular filtration rate(GFR) | up to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Pathological score of liver/kidney preservation injury during surgery | during surgery | |
| Mitochondrial function index of hepatocyte/nephrocyte during surgery | during surgery | |
Not provided
Inclusion Criteria:
Donors:
Recipients:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xia Qiang, investigator | Contact | +86-21-68383775 | xiaqiang@shsmu.edu.cn | |
| Xue Feng, investigator | Contact | +8613761267573 | fengxue6879@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Xia Qiang, investigator | Deparment of Liver Surgery | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ren Ji Hospital | Shanghai | Shanghai Municipality | 200127 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22683850 | Result | 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. | |
| 23742028 | Result |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D015427 | Reperfusion Injury |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| The total incidence of adverse events/incidence of severe adverse events |
| up to 6 months |
| postoperative complications | up to 6 months |
| Early graft function incidence | baseline and 6 months |
| Graft dysfunction incidence | baseline and 6 months |
| Recipient survival | baseline and 6 months |
| Deparment of Liver Surgery, Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University | Shanghai | 200127 | China |
| 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. |
| 21956195 | Result | 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. |
| 24410860 | Result | 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. |
| 25121557 | Result | 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. |
| D013568 | Pathological Conditions, Signs and Symptoms |