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Study on the Effect of Arginine-Vasopressin and Noradrenaline Tartrate on Acute Kidney Injury in Liver Transplant Patients

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of a treatment on patients who have undergone a liver transplantation and are at risk of developing Acute Kidney Injury (AKI). The treatment being tested involves the use of a medication called REVERPLEG, which contains the active substance argipressin. This medication is given as a solution for infusion, meaning it is administered directly into the bloodstream through a vein. The study also involves another medication, NORADRENALINE VIATRIS, which contains noradrenaline tartrate and is also given as a solution for infusion.

The purpose of the study is to see if using a low dose of argipressin during the liver transplant surgery can help reduce the risk of developing AKI afterward. Participants in the study will receive either the argipressin treatment or a placebo during their surgery. The study will monitor the participants for a period after the surgery to observe any effects on kidney function and other health outcomes.

Throughout the study, various health indicators will be tracked, such as the need for blood transfusions, the use of other medications like norepinephrine, and the overall health status of the participants. The study aims to provide valuable information on whether this treatment can improve outcomes for patients undergoing liver transplants and help prevent complications like AKI.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, you will be required to provide signed informed consent. This means you agree to participate after receiving clear information about the study.

    You must be at least 18 years old and scheduled for a liver transplantation to participate.

  2. Step 2

    Preparation for surgery

    Before the liver transplantation surgery, you will be prepared according to standard medical procedures. This includes any necessary pre-operative assessments.

  3. Step 3

    During surgery

    During the liver transplantation surgery, you will receive a low-dose of arginine-vasopressin through an intravenous infusion. This is a solution administered directly into your bloodstream.

    The goal of this medication is to reduce the risk of Acute Kidney Injury after the surgery.

  4. Step 4

    Post-surgery monitoring

    After the surgery, your kidney function will be monitored for the first 7 days to assess any signs of Acute Kidney Injury.

    You will also be monitored for the number of blood products transfused and the need for any additional treatments in the intensive care unit.

  5. Step 5

    Follow-up assessments

    On the third day after surgery, a score called the Sequential Organ Failure Assessment will be used to evaluate your overall health status.

    Your recovery will be tracked for 30 days to determine the number of days you spend outside the intensive care unit and to monitor your overall survival.

Who can join the trial?

4 criteria

  • Age must be 18 years or older.
  • Must be an adult patient who is scheduled for a liver transplantation.
  • Must receive clear information about the study and provide signed informed consent (agreement to participate after understanding the study).
  • Must be a person affiliated with the Social Security system.

Who cannot join the trial?

2 criteria

  • Patients who have had a **liver transplant** cannot participate.
  • Patients with **acute kidney injury** cannot participate. This is a sudden decrease in kidney function.
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Investigated drugs

Arginine-Vasopressin is a medication used in this clinical trial. It is a hormone that helps regulate the body's water balance and blood pressure. In this study, it is given in low doses during liver transplantation surgery. The goal is to see if it can help reduce the risk of kidney problems that sometimes happen after the transplant. By supplementing with this hormone, doctors hope to improve the outcomes for patients undergoing liver transplants.

What is already known about the treatment

Arginine-Vasopressin – Arginine-Vasopressin is administered in low doses during surgery, specifically through an intravenous method, to help reduce the risk of acute kidney injury following liver transplantation. Currently, this medication is being studied in clinical trials to assess its effectiveness in this context, and it is gaining attention in medical literature for its potential benefits. The main therapeutic use of Arginine-Vasopressin in this trial is to support kidney function after liver transplants. At the molecular level, it works by helping the body retain water and maintain blood pressure, which can be crucial during and after surgery. It is classified pharmacologically as a vasopressin analog, which means it mimics the natural hormone vasopressin in the body.

Investigated diseases

  • Acute Kidney Injury

    Acute Kidney Injury (AKI) is a sudden episode of kidney failure or kidney damage that happens within a few hours or days. It causes waste products to build up in the blood and makes it hard for the kidneys to maintain the right balance of fluid in the body. AKI can occur due to various reasons, including reduced blood flow to the kidneys, direct damage to the kidneys, or blockage of the urinary tract. The condition can lead to a decrease in urine output, swelling in the legs, ankles, and around the eyes, and fatigue. As AKI progresses, it can cause complications such as fluid retention, electrolyte imbalances, and increased pressure in the blood vessels. Recovery from AKI can vary, with some individuals experiencing full recovery while others may have lasting kidney damage.

  • Liver Transplantation

    Liver transplantation is a surgical procedure that replaces a diseased liver with a healthy liver from a donor. This procedure is typically considered for individuals with severe liver dysfunction or liver failure. The progression of liver disease leading to transplantation can involve chronic liver conditions such as cirrhosis, hepatitis, or liver cancer. As liver function deteriorates, symptoms may include jaundice, fatigue, swelling, and confusion. The transplantation process involves careful matching of donor and recipient, followed by the surgical removal of the diseased liver and implantation of the donor liver. Post-transplant, the body must adapt to the new organ, and the patient requires ongoing monitoring to ensure the liver functions properly.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-506512-40-00Protocol codeAPHP220827Estimated enrolment304 patientsSponsorAssistance Publique Hopitaux De Paris

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