Effect of Terlipressin on the Incidence of Early Postoperative Acute Kidney Injury in Liver Transplantation Patients

October 25, 2023 updated by: Beijing Tsinghua Chang Gung Hospital

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

acute kidney injury is a relatively common complication in patients with liver transplantation. Most centers have established prediction models for acute kidney injury after liver transplantation, but the incidence cannot be reduced through perioperative anesthesia management. As an vasopressin receptor agonist, terlipressin can increase blood pressure and improve kidney perfusion at the same time, and perioperative application may reduce the incidence of postoperative acute kidney injury

Study Type

Interventional

Enrollment (Estimated)

104

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 1000000
        • Recruiting
        • Beijing Tsinghua Chang Gung Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: experimental group
Continuous terlipressin infusion，Use a syringe to dilute to 50ml Infusion speed is 2ug/kg*h, From the beginning to the end of the surgery.
Drug: Terlipressin
The medication is dispensed by the nursing staff before surgery and given to the anesthesiologist before the procedure begins
Other Names:
  • Glypressin
Placebo Comparator: control group
Continuous normal saline infusion，Use a syringe to draw 50ml Infusion speed is 4ml/h, From the beginning to the end of the surgery.
Drug: normal saline
The medication is dispensed by the nursing staff before surgery and given to the anesthesiologist before the procedure begins
Other Names:
  • normal sodium

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of acute kidney injury after liver transplantation
Time Frame: in 7 days
acute kidney injury diagnostic criteria (2012 edition)
in 7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Tsinghua Chang Gung Hospital

Investigators

  • Study Chair: Huan Zhang, Doctor, department of anesthesia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 18, 2023

Primary Completion (Estimated)

June 30, 2024

Study Completion (Estimated)

June 30, 2024

Study Registration Dates

First Submitted

October 25, 2023

First Submitted That Met QC Criteria

October 25, 2023

First Posted (Actual)

October 31, 2023

Study Record Updates

Last Update Posted (Actual)

October 31, 2023

Last Update Submitted That Met QC Criteria

October 25, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 23344-4-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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