Clinical trial

Effect of Intraoperative Terlipressin on the Incidence of Early Postoperative Acute Kidney Injury in Liver Transplantation Patients: a Randomized, Double-blind, Placebo-controlled Study

Name
23344-4-02
Description
The goal of this clinical trial is to evaluate the effect of intraoperative terlipressin on the incidence of early postoperative acute kidney injury in deceased doner liver transplantation. Patients were randomly divided into experimental group and control group by numerical randomization table. The experimental group was injected with terlipressin perioperative and the control group was injected with placebo
Trial arms
Trial start
2023-08-18
Estimated PCD
2024-06-30
Trial end
2024-06-30
Status
Recruiting
Phase
Early phase I
Treatment
Terlipressin
The medication is dispensed by the nursing staff before surgery and given to the anesthesiologist before the procedure begins
Arms:
experimental group
Other names:
Glypressin
normal saline
The medication is dispensed by the nursing staff before surgery and given to the anesthesiologist before the procedure begins
Arms:
control group
Other names:
normal sodium
Size
104
Primary endpoint
Incidence of acute kidney injury after liver transplantation
in 7 days
Eligibility criteria
Inclusion Criteria: * 1) Patients who plan to undergo liver transplantation in our hospital 2) Patients or family members sign informed consent Exclusion Criteria: * Patients \<18 years old;② Patients undergoing autologous liver transplantation or combined transplantation;③ Patients with lower extremity artery stenosis;(4) Patients with severe heart disease、lung disease、kidney disease;⑤ Patients with severe lung disease;⑥ Patients who used renal replacement therapy before surgery;⑦ the depth of one kidney from the body surface is greater than 4cm;⑧ Patients treated with terlipressin within 2 weeks before surgery⑨ Patients allergic to terlipressin.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}}, 'enrollmentInfo': {'count': 104, 'type': 'ESTIMATED'}}
Updated at
2023-10-31

1 organization

2 products

2 indications