A prospective, double-blind, randomized controlled clinical trial for preventive use of ulinastatin on hepatic ischemia-reperfusion injury.

A prospective, double-blind, randomized controlled clinical trial for preventive use of ulinastatin on hepatic ischemia-reperfusion injury

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR1900021546

Enrollment

Unknown

Registered

2019-02-27

Start date

2019-11-22

Completion date

Unknown

Last updated

2019-11-25

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

Conditions

Hepatic ischemia-reperfusion injury

Interventions

Ulinastatin group:Ulinastatin IV

Placebo group:Normal Saline

Eligibility

Sex/Gender

All

Age

18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18 to 70 years; 2. Planned to perform elective partial hepatectomy (1-6 segments to be removed); 3. Preoperative liver function is Child-Pugh grade A or grade B; 4. The preoperative liver function: ALT, AST, ALP do not exceed 2.0 x normal upper limit (2xULN); 5. No history of drug dependence and alcohol dependence; 6. Expected intraoperative liver inflow occlusion time (full liver or half liver) >= 15 minutes 7. Acknowledge and signed the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Patients with mental illness who require long-term oral medication control; 2. Those who cannot tolerate liver operation (such as decompensated cardiac or pulmonary function, or blood system diseases); 3. Chronic long-term inflammatory stimuli, such as: history of intrahepatic and extrahepatic bile duct stones, color Doppler ultrasound found intrahepatic bile duct stones, kidney stones; 4. Diseases affecting the immune system and the metabolic system, such as: diabetes, systemic lupus erythematosus, etc.; 5. Abnormal state of coagulation function, such as: acute phase of upper gastrointestinal bleeding, acute phase of cerebral infarction; 6. Active infections, such as clinically confirmed upper respiratory tract infections; 7. Decompensation of liver function (Child-C grade), decompensation of renal function (eGFR <60mL); 8. The cumulative liver occlusion time exceeds 120 minutes (may require more aggressive clinical treatment support); 9. Other factors are considered unsuitable for administration of ulinastatin after evaluation by the clinician; 10. Refuse to follow up refuse to participate in the study.

Design outcomes

Primary

Measure	Time frame
Plasma ulinastatin concentration before hepatic inflow occlusion;Liver function (TB, DB, ALT, AST, ALP, GGT);Inflammatory factor(CRP,IL-6,IL-8,IL-10,TNF-a);	—

Secondary

Measure	Time frame
Coagulation Profile(PT,APTT,Fibrinogen,INR);Hemoglobin, serum albumin;time of occlusion;time duration of liver function to come back to normal;	—

Countries

China

Contacts

Public ContactYong Zeng

West China Hospital, Sichuan University

zengyong@medmail.com.cn+86 18980601472

Outcome results

None listed

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