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A parallel randomized placebo-controlled trial on the effect of liver protective drugs during organ function maintenance on early postoperative liver transplantation recipients

A parallel randomized placebo-controlled trial on the effect of liver protective drugs during organ function maintenance on early postoperative liver transplantation recipients

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100047056
Enrollment
Unknown
Registered
2021-06-07
Start date
2021-06-01
Completion date
Unknown
Last updated
2022-01-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

liver transplantation

Interventions

Experimental group1:0.1g glycyrrhizic acid + 250ml 10% glucose injection, intravenous drip
Experimental group2:465mg Polyene phosphatidylcholine + 250ml 10% glucose injection, intravenous drip
Experimental group3:0.1g glycyrrhizic acid +465mg Polyene phosphatidylcholine + 250ml 10% glucose injection, intravenous drip
Control group:250ml 10% glucose injection, intravenous drip

Sponsors

West China Hospital, Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 100 Years

Inclusion criteria

Inclusion criteria: 1.The donor and recipient's family members or legal representatives agreed to participate in the experiment and signed the informed consent; 2.Gender and age are not limited; 3.At least one of the following criteria should be included in the criteria of marginal donor: (1) length of stay in intensive care unit > 7 days; (2) Body mass index > 30 kg / m^2; (3) Death due to hypoxia, stroke or other non traumatic causes; (4) Age > 60 years old; (5) The degree of steatosis was more than 40%; (6) Serum sodium > 165 mmol / L; (7) ALT > 105 U / L, AST > 90 U / L, total bilirubin > 51 µ mol/L ; (8) The serum was positive for hepatitis virus; (9) Split liver transplantation, sepsis, meningitis, personal history of extrahepatic malignancy, long-term hypotension .(diastolic blood pressure < 60 mmHg, lasting more than 2 hours, 10 mmHg = 1.33 kPa) or need a large number of vasoactive drugs to maintain blood pressure. If at least one of the liver function indexes in Clause 7 is met, it is the marginal donor liver with abnormal liver function.

Exclusion criteria

Exclusion criteria: 1. The donor had used liver protection drugs for a period of time 24 hours before admission; 2. There was no biochemical examination of liver function in our hospital 24 hours before the donor was enrolled; 3. The donor may not be able to receive at least one intravenous administration within 24 hours.

Design outcomes

Primary

MeasureTime frame
poor early graft function, PEGF;

Secondary

MeasureTime frame
Pathological morphology and inflammatory status of liver tissue before transplantation;

Countries

China

Contacts

Public ContactLi Jianbo

West China Hospital, Sichuan University

lijianbo@scu.edu.cn+86 18280128017

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026