Clinical Trial of Hydrogen-Rich Celsior Solution Applied in Aging DBD Liver/Kidney Transplantation

NCT02613195 | Unknown Phase 3 DMC

• 1 other identifier: RenJiH-20151020
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to investigate whether hydrogen-rich Celsior solution improve the quality of aging grafts in liver/kidney transplantation.

Conditions

Evidence of Liver Transplantation

Keywords

Ischemia-Reperfusion Injury; oxidative stress; organ preservation; Hydrogen; Kidney Transplantation

Outcome Measures

Primary Outcomes (4)

• 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

Secondary Outcomes (7)

• Pathological score of liver/kidney preservation injury during surgery

  during surgery

• Mitochondrial function index of hepatocyte/nephrocyte during surgery

  during surgery

• 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

Study Arms (2)

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.

Drug: Hydrogen-Rich Celsior Solution

Celsior solution

NO INTERVENTION

Using aging liver/kidney grafts（≥60 years old）, lavaged and cold stored with common Celsior solution for 2-4 hours.

Interventions

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.

Also known as: HR solution

Hydrogen-rich Celsior solution

Eligibility Criteria

• Age: 60 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Donors:
• Age of the donor ≥60 yrs.
• The donor has no historical records of drug abuse, alcoholic abuse, homosexual,or drug addiction, etc.
• Evaluate infections and infectious disease of the donor.
• History of malignant tumor;
• History of hypertension, diabetes, hemophilia, or other anticoagulant disease,kidney donor should not have a history of kidney disease.
• Daily urine volume is approximately normal.
• 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.
• 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).
• The potential donor should has a systolic blood pressure ≥ 50 mm Hg (1mmHg=0.133 kPa) and arterial SaO \> 80%.
• Liver Biochemistry: alanine aminotransferase (ALT) ≤ 6ULN, total bilirubin (TBil) ≤ 50umol/L;Kidney Biochemistry: serum creatinine (sCre) ≤ 2ULN;
• Negative anti-HIV antibody;
• Negative bacterial and fungal culture in blood;
• Ultrasonic diagnosis of fatty liver, trauma, hematoma, lithiasis, etc., as well as size of both kidney, hydronephrosis, nephrolithiasis, etc. if possible.
• 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.

You may not qualify if:

• Donor's age \< 60 yrs;
• The donor has historical records of drug abuse, alcoholic abuse, homosexual, or drug addiction, etc.
• The donor is HIV infected, or has severe infection, or positive bacterial and/ or fungal culture results;
• Uncontrollable hypertension, diabetics;
• Malignant tumor;
• Unstable hemodynamic response or SaO status, such as systolic pressure \<50 mm Hg (1mmHg=0.133 kPa) , or arterial SaO\<80%.
• Liver Biochemistry: alanine aminotransferase (ALT)\>6ULN, total bilirubin (TBil)\>50umol/L;
• Graft liver has a steatosis \>30%, or graft kidney has a proximal tubular necrosis\>50% or obvious glomerular sclerosis.

Sponsors & Collaborators

• RenJi Hospital: lead

Study Sites (2)

Ren Ji Hospital

Shanghai, Shanghai Municipality, 200127, China

Location

Deparment of Liver Surgery, Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University

Shanghai, 200127, China

Location

Related Publications (5)

• 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: 22683850 RESULT

• 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: 23742028 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.

  PMID: 21956195 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.

  PMID: 24410860 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.

  PMID: 25121557 RESULT

MeSH Terms

Conditions

Reperfusion Injury

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Xia Qiang, investigator

  Deparment of Liver Surgery

  STUDY DIRECTOR

Central Study Contacts

Xia Qiang, investigator

CONTACT

+86-21-68383775; xiaqiang@shsmu.edu.cn

Xue Feng, investigator

CONTACT

+8613761267573; fengxue6879@163.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2015
• First Posted: November 24, 2015
• Study Start: January 1, 2016
• Primary Completion: February 1, 2017
• Study Completion: February 1, 2017
• Last Updated: November 24, 2015

Record last verified: 2015-10

Locations

CN (2)