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Effect of Terlipressin on the Incidence of Early Postoperative Acute Kidney Injury in Liver Transplantation Patients
Plain-language guide to NCT06108362: phase 4 randomized trial of Terlipressin, 104 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT06108362
- Phase
- phase 4
- Status
- completed
- Start
- 2023-10-25
- Completion (planned or actual)
- 2024-11-08
- Participants
- 104 (actual)
- Design
- randomized, double-blind, treatment
- Conditions studied
- Acute Kidney Injury; Liver Transplant; Complications
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
This registered phase 4 trial tested Terlipressin.
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.
It had two arms (groups): experimental group (experimental) and control group (placebo comparator).
The registry classes the interventions as drug.
More on the Plan
Acute kidney injury is a relatively common complication in patients with liver transplantation.
Who Took Part
104 actual participants took part.
It was open to people of any sex aged from 18 years up to 70 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Written informed consent provided by the patient or the patient's legally authorized representative.
The full record lists 2 inclusion and 7 exclusion criteria; among the exclusions: patients undergoing autologous liver transplantation or combined organ transplantation; patients with lower-extremity arterial stenosis; patients with severe cardiac, pulmonary, or renal disease.
How the Study Was Run
It was run as a randomized, parallel-group and double-blind study.
The participants were allocated by chance, so the Terlipressin group and the comparison group should start out alike.
The Terlipressin group and the comparison group ran side by side rather than switching.
Blinding on both sides kept the participants and researchers unaware of who received Terlipressin.
Those kept unaware of assignments: participant and care provider.
It started in 2023-10-25 with completion listed for 2024-11-08.
It ran at 1 site in China.
Its stated primary purpose is treatment.
What Was Measured
Primary outcome: Incidence of acute kidney injury after liver transplantation (time frame: in 7 days).
What This Means in Plain Language
Put simply, this is a phase 4, randomized trial of Terlipressin in 104 people.
The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.
More context: the Terlipressin compound page, all human trials.
Our Notes on the Compound
Terlipressin: A synthetic vasopressin analog (Terlivaz) used for kidney failure in advanced liver disease and for variceal bleeding.
Related Pages
Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.