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Study on the Effects of Human Albumin Solution and Electrolyte Drug Combination for Fluid Therapy in Patients Undergoing Laparoscopic Surgery

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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 fluid therapy during laparoscopic surgery, which is a type of surgery performed through small incisions with the help of a camera. The study will compare two different treatments: Ringer's solution, which is a mixture of electrolytes including sodium lactate solution, magnesium chloride hexahydrate, potassium chloride, sodium chloride, and calcium chloride dihydrate, and human albumin solution, a protein derived from human blood. These treatments are used to optimize plasma volume and maintain stable blood flow during surgery.

The purpose of the study is to understand how these fluids affect the body during surgery, especially when the abdomen is inflated with carbon dioxide, which is common in laparoscopic procedures. Participants will receive either Ringer's solution or human albumin solution through an intravenous infusion, which means the fluid is delivered directly into a vein. The study will observe changes in blood components like hemoglobin and albumin, as well as kidney function and fluid balance before and after surgery.

The trial aims to provide insights into the best fluid management practices during surgery to ensure patient safety and improve surgical outcomes. By comparing these two treatments, the study hopes to determine which fluid is more effective in maintaining the necessary blood volume and circulation during the surgical procedure. The findings could help guide future recommendations for fluid therapy in surgical settings.

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, the participant must provide written consent to participate.

    Female participants of childbearing age must use adequate contraception, such as birth control pills, an intrauterine device, or a contraceptive implant, or have a negative pregnancy test. Postmenopausal women must have had no menstruation for 12 months to waive the requirement for effective contraception.

    Participants must belong to the American Society of Anesthesiology classification I to III.

    Participants must be scheduled for major laparoscopic abdominal surgery lasting 90 minutes or more.

    Participants must be between 18 and 80 years old.

  2. Step 2

    Pre-surgery preparation

    Before surgery, participants will receive a fluid therapy regimen to optimize plasma volume and hemodynamics.

    The therapy involves the use of electrolytes and albumin solutions administered intravenously.

  3. Step 3

    During surgery

    During the surgery, the effect of fluid bolus on plasma volume and hemodynamics will be observed.

    The primary focus is on the reduction of hemoglobin levels, which will be mathematically processed in a kinetic model.

  4. Step 4

    Post-surgery monitoring

    After surgery, circulatory physiological measurements will be taken.

    Changes in plasma albumin, plasma creatinine, fluid composition, and fluid balance will be assessed preoperatively and 24 hours postoperatively.

  5. Step 5

    End of participation

    The study is estimated to conclude by December 31, 2025.

    Participants will be monitored until the end of their involvement in the study.

Who can join the trial?

5 criteria

  • The participant must have given their written consent to join the study.
  • For female participants of childbearing age, appropriate birth control must be used, such as birth control pills, an intrauterine device (IUD), or an implant. Alternatively, a negative pregnancy test is required. For postmenopausal women, no menstrual periods for 12 months is needed to waive the birth control requirement.
  • Participants should belong to the ASA (American Society of Anesthesiology) classification I to III. This is a system used to assess the fitness of patients before surgery, with I being the healthiest and III having more health issues.
  • The participant must be scheduled for major laparoscopic abdominal surgery, which is planned to last 90 minutes or more. Laparoscopic surgery is a type of surgery done through small cuts in the abdomen using a camera.
  • Participants must be between 18 and 80 years old.

Who cannot join the trial?

4 criteria

  • Patients who are not within the specified age range for the study.
  • Patients who are not suitable for the type of surgery being studied, which is **laparoscopic surgery**. This is a type of surgery done through small cuts in the body using a camera.
  • Patients who have medical conditions that make it unsafe for them to receive **fluid therapy**. This is a treatment where fluids are given to the body, often through a vein.
  • Patients who are part of a vulnerable population, meaning they might need special protection or care.
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Investigated drugs

  • Albumin

    is a protein solution used in this trial to help increase the volume of blood plasma. It is often used during surgery to maintain blood pressure and improve circulation by expanding the blood volume.

  • Ringer's Solution

    is a type of fluid that contains a mix of salts and water. It is used in this trial to help maintain the body's fluid balance during surgery. It helps to keep the blood pressure stable and supports the circulation of blood.

What is already known about the treatment

  • Albumin

    Albumin is administered intravenously and is used to optimize plasma volume and hemodynamics during surgery, particularly in fluid therapy combined with laparoscopic procedures. It is well-established in medical literature as a volume expander and is commonly used in clinical settings. The main therapeutic indication is to maintain blood volume and pressure during surgical procedures. At the molecular level, albumin works by increasing the oncotic pressure in the blood vessels, which helps retain fluid within the circulatory system. It is classified pharmacologically as a plasma volume expander.

  • Ringer's Solution

    Ringer's solution is administered intravenously and is used to maintain fluid balance and support hemodynamics during surgery, especially in combination with laparoscopic techniques. It is widely recognized in medical literature and practice as a balanced electrolyte solution. The primary therapeutic indication is to provide fluid replacement and maintain electrolyte balance during surgical procedures. Its mechanism of action involves supplying essential electrolytes and fluids to the body, helping to maintain normal cellular function. It is classified as a crystalloid solution.

Investigated diseases

Fluid Therapy in Combination with Laparoscopic Surgery – This condition involves the administration of fluids during laparoscopic surgery, a minimally invasive procedure. The process is crucial as it helps maintain the body's fluid balance, especially when the abdomen is inflated with carbon dioxide to create space for the surgery. The inflation can reduce blood flow back to the heart, necessitating careful fluid management to ensure adequate circulation. The therapy aims to optimize the volume of fluids given to support the body's needs during the surgical procedure. It involves monitoring changes in blood components and fluid balance before and after surgery. This approach is part of modern surgical techniques to enhance patient outcomes.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-513159-33-00Estimated enrolment60 patientsSponsorRegion Oestergoetland

sourced from the EU Clinical Trials Register and site verification

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