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A randomized, double-blind, randomized controlled clinical trial of prophylactic corticosteroids on hepatic ischemia-reperfusion injury

A randomized, double-blind, randomized controlled clinical trial of prophylactic corticosteroids on hepatic ischemia-reperfusion injury

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900021547
Enrollment
Unknown
Registered
2019-02-27
Start date
2017-12-01
Completion date
Unknown
Last updated
2019-03-04

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

Conditions

Ischemia-reperfusion of liver

Interventions

Hydrocortisone group:The use of hydrocortisone 100mg before interruption in operation, and intravenous drip of 100mg qd, 100mg qd, 50mg qd, common medicine 3 days after operation.
methylprednisolone group:Use of Methylprednisolone 80mg before interruption, and intravenous drip of 80mg qd, 80mg qd, 40mg qd, common medicine 3 days after operation.
placebo group:Use of normal saline 100ml before interruption, and intravenous drip of normal saline 100ml, common medicine 3 days after operation.

Sponsors

West China Hospital, Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 100 Years

Inclusion criteria

Inclusion criteria: 1. Patients know the research process and sign informed consent; 2. HBsAg(+), HCV (-), HBV-DNA<10^4 IU/mL; 3. ALT/AST/ALP/GGT < 1.5 ULN; 4. Child-Class A/B; 5. PCT/CRP/IL-6 were normal; 6. No history of intrahepatic and extrahepatic bile duct stones. No signs of extrahepatic and extrahepatic bile duct stones were seen in ultrasound; 7. Intraoperative total liver inflow occlusion.

Exclusion criteria

Exclusion criteria: 1. Chronic long-term inflammatory stimulation, such as ultrasound found intrahepatic and extrahepatic bile duct stones and renal calculi; 2. Diseases such as diabetes, systemic lupus erythematosus, which affect the immune and metabolic system; 3. Abnormal state of coagulation function, such as acute stage of upper gastrointestinal bleeding and acute stage of cerebral infarction; 4. Active infection, such as: clinical confirmation of upper respiratory tract infection, and active hepatitis B infection (HBV DNA fluorescence quantitative >1.0e+6 iu/ml); 5. Severe decompensated liver function (Child-Class C) and renal decompensation (eGFR<30mL); 6. The time of total liver inflow occlusion was less than 30 minutes or more than 90 minutes; 7. Other factors were considered inappropriate for glucocorticoids after being evaluated by clinicians.

Design outcomes

Primary

MeasureTime frame
Inflammatory factors;Liver function;

Countries

China

Contacts

Public ContactYong Zeng

West China Hospital, Sichuan University

jingzhe_liao@qq.com+86 18980601472

Outcome results

None listed

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