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

3 1 1 1

What is this study about?

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.

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 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 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 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 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 Study?

  • 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 Study?

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

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
University Hospital Of Clermont-Ferrand Clermont Ferrand France
Centre Hospitalier Universitaire De Bordeaux Bordeaux France
Centre Hospitalier Universitaire De Lille Lille France

Other Sites

Site Name City Country Status
Centre Hospitalier Lyon Sud Pierre Benite France
Hopital Beaujon Clichy France
Camqoa Hcxhdujgaiv Rxxeddwl Uedsyjgbihaqn Da Tucno Tours France
Hohyhaer Urwurtchbynhie Sglzrzdvfv &jaavue Hzdgvgi di Hdnzshhqxvf STRASBOURG, Alsace France

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
France France
Recruiting
01.01.2024

Trial locations

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.

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 ID:
2023-506512-40-00
Protocol code:
APHP220827
Trial Phase:
Therapeutic confirmatory (Phase III)

Other Trials to Consider

  • Effect of sodium hydrogen carbonate on kidney health in critically ill patients with metabolic acidosis and acute kidney injury

    Recruiting

    3 1 1 1
    Investigated diseases:
    Germany
  • A study to evaluate the effectiveness of R2R01 in preventing acute kidney injury in patients at high risk following heart surgery.

    Recruiting

    2 1 1
    Investigated drugs:
    Germany Italy