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Study on the Effects of Sodium Lactate and Saline Solutions in Patients with Septic Shock

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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 two different treatments for patients experiencing septic shock, a serious condition that occurs when an infection leads to dangerously low blood pressure and organ failure. The treatments being compared are sodium lactate and a 3% saline solution, both administered through an intravenous infusion, which means they are given directly into the bloodstream. The purpose of the study is to compare how these treatments affect the heart and blood circulation in patients with septic shock.

Participants in the study will receive either sodium lactate or 3% saline solution, and the effects on their heart function and blood pressure will be monitored. The study will observe changes in the heart's ability to pump blood and the stability of blood pressure at different times after the treatment begins. Additionally, the study will compare certain blood test results between the two groups to understand how each treatment affects the body's balance of acids and bases, as well as electrolytes, which are minerals in the blood that help with various bodily functions.

This trial is designed to be double-blinded, meaning neither the participants nor the researchers know which treatment is being given to each participant, to ensure unbiased results. The study aims to provide valuable information on the best way to manage fluid resuscitation in septic shock, potentially improving treatment outcomes for patients with this life-threatening condition.

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 for the study is determined based on specific criteria, including age between 18 and 90 years, presence of septic shock, and a need for fluid resuscitation.

    Informed consent is required to participate in the study.

  2. Step 2

    Initial assessment

    An initial assessment is conducted to evaluate the current health status, including blood lactate levels and other vital signs.

    This assessment helps to establish a baseline for monitoring changes during the trial.

  3. Step 3

    Randomization and treatment

    Participants are randomly assigned to receive either 0.5M sodium lactate or 3% saline solution.

    The assigned solution is administered intravenously at a dosage of 3 ml per kg of body weight over a period of 30 minutes.

  4. Step 4

    Monitoring during infusion

    Cardiac stroke work is monitored using echocardiography and arterial pressure measurements at the start of the infusion, 30 minutes, and 60 minutes after the start.

    Parameters such as stroke volume and mean arterial pressure are recorded to assess the effects of the treatment.

  5. Step 5

    Laboratory tests

    Laboratory tests are conducted to compare arterial blood gases and electrolyte levels between the two study groups.

    These tests help to evaluate the physiological impact of the treatments.

  6. Step 6

    Completion of participation

    Upon completion of the monitoring and tests, participation in the study concludes.

    Results from the study contribute to understanding the effects of the treatments on septic shock patients.

Who can join the trial?

12 criteria

  • Age between 18 and 90 years old.
  • Have septic shock, which is a severe infection causing organ failure. This includes:
    • An acute change in the SOFA score of 2 or more. The SOFA score is a way to measure how well your organs are working.
    • Need for a vasopressor drug to keep blood pressure at a certain level. A vasopressor drug helps raise blood pressure.
    • Blood lactate level of 2 mmol/L or higher in the last 24 hours. Lactate is a substance in the blood that can increase when the body is under stress.
    • Likely need for fluid resuscitation, which means needing fluids to help the body function better. This includes:
      • Poor blood flow to the body's tissues, shown by at least two of the following:
        • Blue or purple skin with slow return of color when pressed (3 seconds or more).
        • Low urine output, less than 0.5 ml/kg/hour for at least 6 hours.
        • Low oxygen levels in the blood, less than 70%.
        • Confusion or difficulty thinking clearly.
        • Tests showing the heart can respond to more fluids, shown by at least one of the following:
          • A positive passive leg raising test, which is a simple test to see if more fluids will help.
          • Changes in blood pressure or heart volume greater than 12%.
          • Changes in the size of a large vein in the body greater than 12%.
          • Must sign an informed consent form, which means agreeing to participate after understanding the study details.

Who cannot join the trial?

4 criteria

  • Patients who do not have septic shock. Septic shock is a serious condition that happens when an infection leads to very low blood pressure.
  • Patients who do not need fluid resuscitation. Fluid resuscitation is a treatment to give fluids to the body to help improve blood flow and pressure.
  • 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

  • 0.5M Sodium Lactate

    is a solution used in this study to help manage septic shock. It is administered intravenously to patients to assess its effects on blood flow and acid-base balance. The goal is to see how well it helps stabilize patients by improving circulation and maintaining the right balance of acids and bases in the body.

  • 3% Saline Solution

    is another intravenous fluid used in the trial for patients with septic shock. This solution is also being tested for its ability to improve blood flow and maintain acid-base balance. The study aims to compare its effectiveness with that of 0.5M Sodium Lactate in managing the symptoms of septic shock.

What is already known about the treatment

  • Sodium Lactate

    Sodium Lactate is administered intravenously and is currently being studied in clinical trials for its effects on patients with septic shock. It is primarily used to manage fluid resuscitation in these patients. The mechanism of action involves providing lactate ions, which can be converted to bicarbonate in the liver, helping to correct acid-base imbalances. It is classified as an electrolyte solution.

  • Saline Solution (3% NaCl)

    This medication is given intravenously and is under investigation in clinical trials for its role in treating septic shock. It is used to provide fluid resuscitation in patients experiencing this condition. The solution works by increasing the sodium concentration in the blood, which helps to restore fluid balance and improve blood pressure. It is categorized as a hypertonic saline solution.

Investigated diseases

Septic Shock – Septic shock is a severe and widespread infection that leads to dangerously low blood pressure and abnormalities in cellular metabolism. It occurs when an infection in the body triggers an extreme immune response, causing inflammation and blood clotting throughout the body. This condition can lead to a significant drop in blood pressure, reducing blood flow to vital organs and potentially causing organ failure. Patients with septic shock often require immediate medical intervention, including fluid resuscitation, to stabilize their condition. The progression of septic shock can be rapid, necessitating close monitoring and supportive care.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-517927-37-00Protocol codeMJIP1.0Estimated enrolment40 patientsSponsorFakultni Nemocnice Plzen

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