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Study on Human Albumin Solution and Ringer Lactate for Patients Undergoing Cytoreductive Surgery with Hyperthermic Intraperitoneal Chemotherapy

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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 patients undergoing a specific type of cancer treatment known as cytoreductive surgery combined with hyperthermic intraperitoneal chemotherapy (HIPEC). This treatment is often used for patients with cancer that has spread to the lining of the abdomen, such as from gynecological or digestive origins. The study aims to evaluate the effectiveness of using a combination of 20% human albumin solution and Ringer Lactate compared to Ringer Lactate alone for fluid replacement during this surgery.

The purpose of the study is to assess how well the combination of these fluids works in improving recovery after surgery. Participants will be randomly assigned to receive either the combination of human albumin solution and Ringer Lactate or Ringer Lactate alone. The study will monitor the participants' recovery over a period of 28 days after the surgery, looking at various outcomes such as complications, the need for additional medical support, and overall recovery.

Throughout the study, participants will receive regular check-ups to monitor their health and any potential side effects. The trial will help determine if the addition of human albumin solution to the fluid replacement strategy can lead to better outcomes for patients undergoing this intensive cancer treatment. The study is expected to continue until 2027, with recruitment starting in 2025.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Eligibility is confirmed based on criteria such as being 18 years or older, having planned surgery, and providing consent.

    Participation is confirmed after meeting all necessary conditions.

  2. Step 2

    Pre-surgery preparation

    Preparation for the surgery involves standard medical assessments and planning for fluid replacement therapy.

  3. Step 3

    Surgery and fluid therapy

    During the surgery, fluid replacement is managed using either 20% human albumin solution combined with Ringer Lactate or Ringer Lactate alone.

    The fluid is administered through a method called parenteral infusion, which means it is given directly into the bloodstream.

  4. Step 4

    Post-surgery monitoring

    Monitoring occurs for 28 days after surgery to assess recovery and any complications.

    The Comprehensive Complication Index (CCI) score is evaluated at day 28 to measure overall recovery.

  5. Step 5

    Additional assessments

    Secondary assessments include monitoring fluid therapy volume, complications, and other health indicators such as the need for mechanical ventilation and renal therapy.

    The SOFA score is used to evaluate organ function before and after surgery.

  6. Step 6

    Final evaluation

    The study concludes with a final evaluation of outcomes, including days spent outside intensive care and overall survival at day 28.

    Any hypersensitivity reactions to albumin are monitored up to 133 days.

Who can join the trial?

4 criteria

  • Must be **18 years old or older**.
  • Must have a **planned cytoreductive surgery** with **HIPEC** for **peritoneal carcinomatosis**. This means a surgery to remove cancer cells from the lining of the abdomen, followed by a special heated chemotherapy treatment.
  • Must be a **volunteer for the study** and have provided **written informed consent**. This means you agree to participate and have signed a form saying you understand what the study involves.
  • Must be **affiliated with the French Health Insurance**. This means you need to be part of the French health system.

Who cannot join the trial?

3 criteria

  • Patients who are not undergoing cytoreductive surgery with hyperthermic intraperitoneal chemotherapy (HIPEC). This is a type of surgery combined with heated chemotherapy applied directly inside the abdomen.
  • Patients who are not within the specified age range for the study.
  • Patients who belong to a vulnerable population, which means groups that might need special protection or care.
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Investigated drugs

  • Human 20% Albumin Solution

    is a medication used in this trial to help manage fluid levels in the body. It is a concentrated form of albumin, a protein found in blood plasma, and is used to restore and maintain blood volume. In this study, it is combined with Ringer Lactate to evaluate its effectiveness in improving recovery after surgery.

  • Ringer Lactate

    is a fluid commonly used in medical settings to replace lost fluids and electrolytes. It is often used during surgeries to maintain the body's fluid balance. In this trial, Ringer Lactate is used both alone and in combination with human 20% albumin solution to compare their effects on patient recovery after surgery.

What is already known about the treatment

Human 20% Albumin Solution – This medication is administered intravenously and is used in combination with Ringer Lactate for fluid replacement during specific surgical procedures. It is currently being studied in clinical trials to evaluate its effectiveness in improving postoperative outcomes in patients undergoing cytoreductive surgery with hyperthermic intraperitoneal chemotherapy. The main therapeutic indication is to manage fluid balance during surgery. At the molecular level, albumin works by maintaining oncotic pressure, which helps keep fluid within the blood vessels. It is classified as a plasma volume expander.

Investigated diseases

Cytoreductive Surgery with Hyperthermic Intraperitoneal Chemotherapy – This is a treatment approach rather than a disease, used primarily for certain types of cancer that have spread to the lining of the abdominal cavity. The procedure involves surgically removing as much of the tumor as possible, followed by the direct application of heated chemotherapy drugs into the abdominal cavity. The heat is intended to enhance the effectiveness of the chemotherapy. This method aims to target cancer cells more directly and reduce the likelihood of recurrence. It is typically used in cases where traditional chemotherapy alone is not sufficient. The process can be complex and requires careful monitoring of the patient's condition during and after the procedure.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-510943-76-00Protocol codeAPHP230864Estimated enrolment140 patientsSponsorAssistance Publique Hopitaux De Paris

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