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Study on the Effects of Ringer's Acetate Solution in Healthy Volunteers with Experimental Low Blood Volume

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 called Ringer's acetate solution in healthy human volunteers. The study is particularly interested in understanding how this solution affects the body during a condition known as hypovolemia, which is when there is a decreased volume of blood circulating in the body. The treatment involves a solution that contains several substances, including magnesium chloride hexahydrate, potassium chloride, sodium chloride, calcium chloride dihydrate, and sodium acetate trihydrate. These substances are delivered through an intravenous injection, which means they are given directly into a vein.

The purpose of the study is to assess how long the effects of the Ringer's acetate solution last in the body, particularly focusing on its impact on blood flow and volume. Participants in the study will receive the solution, and their body's response will be monitored to see how it affects their blood circulation and volume. The study will compare the effects of the solution with no intravenous fluids to understand its specific impact during hypovolemia compared to normal blood volume conditions, known as euvolemia.

Throughout the study, participants will undergo various assessments to measure how their body responds to the treatment. These assessments will help researchers understand the duration of the solution's effects on the heart and blood vessels. The study aims to provide valuable insights into how Ringer's acetate can be used to manage blood volume and circulation in different conditions.

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 sign an informed consent form. This form confirms your understanding of the study and your agreement to participate.

    You must be between 18 to 40 years old and in good health, as determined by a medical evaluation, including a medical history review, physical examination, and a focused cardiac ultrasound.

  2. Step 2

    Preparation for the trial

    Before the trial begins, you will be briefed on the procedures and what to expect during the study.

    Female participants must use adequate birth control if they are of childbearing potential.

  3. Step 3

    Receiving the solution

    During the trial, you will receive a solution called Ringer-acetat Fresenius Kabi through an intravenous slow bolus injection. This means the solution will be administered directly into your bloodstream at a controlled pace.

    The solution contains several components: magnesium chloride hexahydrate, potassium chloride, sodium chloride, calcium chloride dihydrate, and sodium acetate trihydrate.

  4. Step 4

    Monitoring and assessment

    Throughout the trial, your body's response to the solution will be closely monitored. This includes measuring the duration of the hemodynamic effect, which refers to how the solution affects your blood flow and heart function.

    The primary focus will be on the half-life of your cardiac stroke volume, which is the amount of blood pumped by your heart with each beat, relative to the baseline measurement taken before the solution was administered.

  5. Step 5

    Completion of the trial

    The trial is expected to conclude by July 29, 2024. Upon completion, you will be informed of any findings related to your participation.

    Your involvement in the study will contribute to understanding the effects of the solution during conditions of reduced blood volume, known as hypovolemia.

Who can join the trial?

4 criteria

  • Participant must be between 18 and 40 years old at the time of signing the informed consent.
  • Participants should be overtly healthy, meaning they should not have any obvious health problems. This will be determined by a medical evaluation, which includes checking their medical history, a physical examination, and a focused cardiac ultrasound (a special heart scan).
  • Female participants must use adequate birth control if they are capable of having children.
  • Participants must be capable of giving signed informed consent, which means they understand the study and agree to follow the requirements and restrictions listed in the informed consent form.

Who cannot join the trial?

1 criterion

  • Patients with **hypovolemia** cannot participate. Hypovolemia means having a low blood volume, which can happen if you lose a lot of blood or fluids.
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Investigated drugs

Ringer's Acetate is a type of intravenous fluid that is used to help maintain the balance of fluids in the body. In this clinical trial, it is being used to study its effects on blood flow and volume in the body, especially during situations where the body might have less fluid than normal, known as hypovolemia. The goal is to understand how long the effects of this fluid last when given as a quick injection, known as a bolus, compared to not receiving any intravenous fluids at all. This helps researchers learn more about how the body responds to fluid changes and how Ringer's Acetate can help in managing these changes.

What is already known about the treatment

Ringer's Acetate – Ringer's Acetate is administered intravenously, meaning it is given directly into a vein through an IV. It is currently being studied in clinical trials to understand its effects on blood flow and volume in the body, particularly during conditions of low blood volume, known as hypovolemia. The main use of Ringer's Acetate is to treat or prevent dehydration and to restore fluid balance in the body. At the molecular level, it works by providing essential electrolytes and fluids that help maintain the proper function of cells and organs. It is classified as a crystalloid solution, which is a type of fluid used to replace lost body fluids.

Investigated diseases

Hypovolemia – Hypovolemia is a condition characterized by a decreased volume of blood plasma in the body. It typically occurs due to significant fluid loss, which can result from bleeding, dehydration, or severe burns. As the condition progresses, the body may experience reduced blood flow to vital organs, leading to symptoms such as dizziness, weakness, and rapid heartbeat. The body attempts to compensate for the reduced blood volume by constricting blood vessels and increasing heart rate. If fluid loss continues, it can lead to more severe symptoms, including confusion and decreased urine output. The progression of hypovolemia depends on the underlying cause and the body's ability to restore fluid balance.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-503946-30-00Estimated enrolment12 patientsSponsorOslo University Hospital HF

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