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

NCT06108362 | Unknown Phase 4

• 1 other identifier: 23344-4-02
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Acute Kidney Injury; Liver Transplant; Complications

Keywords

terlipressin; Liver Transplant

Outcome Measures

Primary Outcomes (1)

• Incidence of acute kidney injury after liver transplantation

  acute kidney injury diagnostic criteria (2012 edition)

  in 7 days

Study Arms (2)

experimental group

EXPERIMENTAL

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

control group

PLACEBO COMPARATOR

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

Interventions

Terlipressin DRUG

The medication is dispensed by the nursing staff before surgery and given to the anesthesiologist before the procedure begins

Also known as: Glypressin

experimental group

normal saline DRUG

The medication is dispensed by the nursing staff before surgery and given to the anesthesiologist before the procedure begins

Also known as: normal sodium

control group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \) Patients who plan to undergo liver transplantation in our hospital 2) Patients or family members sign informed consent

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing Tsinghua Chang Gung Hospital: lead

Study Sites (1)

Beijing Tsinghua Chang Gung Hospital

Beijing, Beijing Municipality, 1000000, China

RECRUITING

MeSH Terms

Conditions

Acute Kidney Injury

Interventions

Terlipressin; Saline Solution

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Lypressin; Vasopressins; Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Huan Zhang, Doctor

  department of anesthesia

  STUDY CHAIR

Central Study Contacts

Ziheng Qi, Doctor

CONTACT

15373598688; 469836626@qq.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2023
• First Posted: October 31, 2023
• Study Start: August 18, 2023
• Primary Completion: June 30, 2024
• Study Completion: June 30, 2024
• Last Updated: October 31, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)