Skip to content

Prospective, randomized, controlled study on the effect of spironolactone on early graft dysfunction after liver transplantation ——A single-center clinical study

Prospective, randomized, controlled study on the effect of spironolactone on early graft dysfunction after liver transplantation ——A single-center clinical study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400091778
Enrollment
Unknown
Registered
2024-11-04
Start date
2024-11-15
Completion date
Unknown
Last updated
2024-11-11

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

Conditions

With transplanted liver

Interventions

Basic administration group + spironolactone:Spironolactone was given orally twice a day from 3 days before liver transplantation and on the first day after operation, 20 mg once a day, until discharge
Control group:From 3 days before liver transplantation and 1 day after operation, placebo was given orally twice a day, 20 mg once, until discharge on the 28 th day.

Sponsors

Xiang 'an Hospital Affiliated to Xiamen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1.18 years = age = 75 years, regardless of gender 2. After liver transplantation 3.Graft dysfunction diagnosed by blood test or clinical diagnosis : (1) TB = 171umol / L on the 7th day after operation ; (2) international normalized ratio ( INR ) = 1.6 on the 7th day after operation ;(3) AST or ALT > 2 000 U / L within 7 days after operation, which was consistent with one or more of the above conditions. 4.Participants were informed and voluntarily signed informed consent, can better communicate in language or written, good compliance 5.Swallowing function is normal, and can cooperate with swallowing drugs by screening the results of laboratory tests suggest that there is sufficient organ function.

Exclusion criteria

Exclusion criteria: 1. suffering from serious organic diseases, such as cancer, coronary heart disease, myocardial infarction and stroke 2.It cannot guarantee sufficient time to participate in the project 3.Known allergies to any component of the intervention treatment in this study 4. patients with severe gastrointestinal problems ( such as life-threatening intestinal obstruction, perforation and bleeding ) requiring immediate treatment 5.any researcher believes that participants should be excluded from the study.

Design outcomes

Primary

MeasureTime frame
Serum biochemical and coagulation indexes were measured 28 days before liver transplantation.;

Secondary

MeasureTime frame
Incidence of metabolic complications such as infection, rejection, bile duct obstruction, hyperuricemia and hyperlipidemia within 3 months after operation.;The frequency of tacrolimus adjustment within 3 months after operation;The quality of life, mental state and nutritional status were evaluated at 28 days, 1 month and 3 months after operation.;The compliance rate of tacrolimus concentration within 3 months after operation;Direct and indirect costs associated with the treatment and management of liver transplant recipients.;

Countries

China

Contacts

Public ContactLi Hao

Xiang 'an Hospital Affiliated to Xiamen University

lihao6656@163.com+86 152 1668 9396

Outcome results

None listed

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