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Study of Human Albumin Treatment to Prevent Kidney Dysfunction in Adult Patients After Liver Transplantation

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 study examines kidney problems that can occur after liver transplantation. The research focuses on the use of human albumin solution, which is a protein naturally found in blood, given through an infusion into the vein. The purpose is to determine if maintaining higher levels of albumin in the blood can reduce the risk of developing acute kidney injury in the first week after liver transplant surgery.

The study compares two different approaches to giving albumin solution to transplant patients. In one group, patients receive albumin to maintain higher blood levels (above 30 grams per liter), while the other group receives albumin only when their levels fall very low (20 grams per liter or below). The treatment continues for five days after the transplant surgery.

Throughout the study, doctors monitor various aspects of patient recovery, including kidney function, infections, time spent in the intensive care unit, and how well the transplanted liver is working. They also track other important factors such as the need for breathing support and the body's immune response to the transplant.

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

    Initial assessment after liver transplant

    After your liver transplant surgery, your blood albumin levels will be measured

    Based on these measurements, you will be assigned to one of two treatment groups

  2. Step 2

    Treatment period - first 5 days

    You will receive human albumin solution through an intravenous infusion

    If you are in the treatment group, albumin will be given to maintain your blood levels above 30g/L

    If you are in the control group, albumin will be given only when your blood levels fall to 20g/L or below

    Your kidney function will be closely monitored during this period

  3. Step 3

    Monitoring period - Day 7

    Your kidney function will be assessed to check for signs of kidney problems

    Various blood tests will be performed to evaluate your condition

  4. Step 4

    Extended monitoring - up to Day 28

    Your recovery will continue to be monitored for various aspects including:

    Checking for any signs of infection

    Monitoring your liver function

    Evaluating your response to anti-rejection medications

    Tracking your time in the intensive care unit

    Assessing your overall recovery progress

  5. Step 5

    Study completion

    The study monitoring period ends after 28 days

    Your regular post-transplant care will continue as needed

Who can join the trial?

5 criteria

  • You must be at least 18 years old
  • You must be scheduled to receive your first liver transplant from a deceased donor (the transplant must be liver only)
  • You must be able to understand the purpose and risks involved in participating in the study
  • You must provide written informed consent (a signed document stating you agree to participate in the study)
  • Both men and women can participate in this study

Who cannot join the trial?

10 criteria

  • Patients younger than 18 years old cannot participate in the study
  • Patients who have previously received a liver transplant are not eligible
  • Patients with known allergic reactions to albumin (a blood protein) cannot participate
  • Patients with severe kidney failure requiring dialysis before transplantation are excluded
  • Patients who are pregnant or breastfeeding cannot take part in the study
  • Those who are participating in other clinical trials at the same time cannot be enrolled
  • Patients who are unable to provide informed consent cannot participate
  • Individuals with severe heart conditions that might affect recovery from transplantation are excluded
  • Patients with active infections that could compromise transplant outcomes cannot participate
  • Those with uncontrolled blood pressure are not eligible for the study
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Investigated drugs

Human Albumin is a protein naturally found in blood plasma. In this trial, it is administered as a medical product to patients after liver transplantation. This protein helps maintain proper fluid balance in the blood vessels and is essential for transporting various substances throughout the body. The treatment aims to maintain adequate albumin levels in the blood to protect kidney function after liver transplant surgery.

What is already known about the treatment

Human Albumin - A blood-derived protein solution administered intravenously to maintain adequate protein levels in the blood. This naturally occurring protein is widely used in medical practice, particularly in critical care and surgery, with strong evidence supporting its efficacy in liver transplantation cases. Human albumin works by maintaining proper blood volume and preventing fluid leakage from blood vessels into surrounding tissues, while also serving as a transport protein for various substances in the blood. Classified as a plasma volume expander and protein therapeutic, it is specifically used to prevent kidney dysfunction in liver transplant patients by maintaining serum albumin levels above 30g/L, which helps preserve proper blood circulation and kidney function during the critical post-transplant period.

Investigated diseases

  • Acute Kidney Injury (AKI)

    A sudden decrease in kidney function that develops within a few hours or days. The condition affects the kidneys' ability to filter waste products from the blood, maintain fluid balance, and regulate various body functions. AKI can cause swelling in various parts of the body, decreased urine output, and changes in blood chemistry. The condition can develop due to various causes, including reduced blood flow to the kidneys, direct kidney damage, or blockage in the urinary tract.

  • Liver Transplantation Complications

    A condition that occurs after receiving a new liver, where the body needs to adapt to the transplanted organ. During this period, various changes occur in the body's systems, including fluid balance, blood circulation, and immune response. The body undergoes significant physiological adjustments as it works to accept and function with the new liver.

  • Early Graft Dysfunction

    A condition that can develop shortly after liver transplantation where the new liver shows signs of poor function. The transplanted liver may struggle to perform its normal functions of protein synthesis, toxin removal, and bile production. This condition typically manifests in the first few days after transplantation.

  • Tacrolimus-induced Neurotoxicity

    A condition that can develop in transplant patients taking tacrolimus medication, affecting the nervous system. It can cause various neurological symptoms, including tremors, headaches, and changes in mental status. The condition is related to the body's response to immunosuppressive medication.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-514804-14-00Protocol code35RC22_9739_HALTEstimated enrolment400 patientsSponsorCentre Hospitalier Universitaire De Rennes

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