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Study on Reducing Sodium Chloride and Glucose in Fluids for Critically Ill Patients

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What is this trial about?

A plain-language summary of the goals, design and what participants do

The clinical trial, known as CRUSADERS, is focused on critically ill patients who are in the Intensive Care Unit (ICU). The study aims to explore the effects of reducing the amount of sodium chloride in the fluids given to these patients. Sodium chloride is commonly known as salt, and it is often found in the fluids used for medical treatments. The trial will compare different fluid treatments to see if lowering the salt content can lead to better outcomes for patients, such as improved survival rates and reduced need for support for breathing and kidney function.

Several types of fluid solutions will be used in the study. These include a solution with sodium chloride alone, a combination of sodium chloride and glucose monohydrate (a form of sugar), a solution with just glucose monohydrate, and a more complex solution called Plasmalyte A, which contains a mix of substances like magnesium chloride hexahydrate, potassium chloride, sodium acetate trihydrate, and sodium gluconate. These solutions are given to patients through an intravenous (IV) line, which means they are delivered directly into the bloodstream.

The purpose of the study is to determine if reducing the salt content in these fluids can improve patient outcomes. The trial will monitor various health indicators over a period of time, including the number of days patients are alive without needing life support, as well as occurrences of conditions like low or high sodium levels, fluid retention, and kidney injury. The study will also track the use of mechanical ventilation and the overall length of stay in the ICU. The trial is expected to continue until 2028, with the goal of providing valuable insights into the best fluid management strategies for critically ill patients.

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 admitted to the intensive care unit (ICU) due to a medical or surgical emergency. Your condition is expected to require ICU care for at least two more days.

    You will be informed about the study's objective, which is to reduce the sodium chloride burdens in critically ill patients to improve outcomes such as survival and organ support.

  2. Step 2

    Initial assessment

    An initial assessment will be conducted to determine your eligibility. You must be at least 18 years old and expected to receive a certain amount of fluids during the first 24 hours after joining the study.

  3. Step 3

    Fluid administration

    You will receive fluids through an intravenous (IV) line. The types of fluids used in the study include sodium chloride, glucose, and a combination of electrolytes. These are administered as solutions for infusion.

    The specific fluids you receive will depend on the study group you are assigned to. The goal is to manage the sodium and chloride content in the fluids you receive.

  4. Step 4

    Monitoring and data collection

    Throughout the study, your health will be closely monitored. This includes tracking your fluid balance, sodium, chloride, and glucose levels, as well as any occurrences of conditions like hyponatremia (low sodium levels) or hypernatremia (high sodium levels).

    Your need for life support, such as mechanical ventilation, and any kidney-related issues will also be observed.

  5. Step 5

    Study duration

    The study will continue for a period of time, with the primary endpoint being the number of days you are alive and without life support at 90 days after ICU admission.

    Secondary endpoints include various health outcomes and measurements related to fluid and electrolyte balance.

Who can join the trial?

4 criteria

  • Must be at least 18 years old.
  • Must be a patient admitted to the Intensive Care Unit (ICU) for medical or surgical emergencies, including complications from planned surgeries.
  • The doctor believes the patient will need to stay in the ICU for at least two more days, which means the condition is severe or complex.
  • The patient is expected to receive at least 300 mL of fluid creep or at least 1 liter of maintenance fluid within the first 24 hours after joining the study. Fluid creep refers to the unintentional intake of fluids that occur during medical treatment.

Who cannot join the trial?

1 criterion

  • Patients who are critically ill cannot participate. This means patients who are extremely sick and need intensive medical care.
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Investigated drugs

Sodium Chloride is a common salt solution used in medical settings. In this trial, it is being studied to see if reducing its use in fluids given to critically ill patients can improve their health outcomes. The focus is on how much sodium and chloride are in the fluids that patients receive, and whether using less of these salts can help reduce the need for breathing and kidney support, and potentially lower the risk of death.

What is already known about the treatment

Sodium Chloride Reduction Strategy – This approach involves adjusting the amount of sodium chloride in fluids given to critically ill patients, aiming to improve their health outcomes. Currently, this strategy is being explored in clinical trials to see if it can reduce the need for respiratory and kidney support and lower mortality rates. The main therapeutic goal is to manage fluid levels in the body more effectively by using fluids with less sodium and chloride. At the molecular level, this strategy works by reducing the excess sodium and chloride that can accumulate in the body, which may help organs function better. This approach falls under the pharmacological classification of fluid and electrolyte management.

Investigated diseases

  • Hyponatremia

    Hyponatremia is a condition characterized by low levels of sodium in the blood. It can occur when the body retains too much water, diluting the sodium, or when sodium is lost through excessive sweating, vomiting, or diarrhea. As sodium levels drop, cells begin to swell, which can affect brain function. Symptoms may include headache, confusion, seizures, and fatigue. The progression of hyponatremia depends on the underlying cause and the speed at which sodium levels decrease. If not addressed, it can lead to more severe neurological symptoms.

  • Hypernatremia

    Hypernatremia is a condition where there is an excess of sodium in the blood. It often results from dehydration, where water loss exceeds sodium loss, or from excessive sodium intake. As sodium levels rise, water moves out of cells, causing them to shrink. This can lead to symptoms such as thirst, confusion, muscle twitching, and restlessness. The severity of symptoms depends on how quickly the sodium levels increase. If left unchecked, it can affect brain function and lead to more serious complications.

  • Hyperchloremia

    Hyperchloremia is characterized by an elevated level of chloride in the blood. It often occurs alongside other electrolyte imbalances and can result from dehydration, kidney dysfunction, or excessive intake of chloride-rich fluids. As chloride levels rise, it can disrupt the acid-base balance in the body, leading to symptoms like fatigue, weakness, and deep, rapid breathing. The progression of hyperchloremia is influenced by the underlying cause and the body's ability to restore balance. If not managed, it can contribute to further electrolyte disturbances.

  • Acute Kidney Injury

    Acute Kidney Injury (AKI) is a sudden decline in kidney function, leading to the accumulation of waste products in the blood. It can result from factors such as reduced blood flow to the kidneys, direct kidney damage, or obstruction of urine flow. As kidney function deteriorates, symptoms like decreased urine output, fluid retention, and fatigue may occur. The progression of AKI varies depending on the cause and the severity of the injury. If not addressed, it can lead to more significant kidney damage and complications.

  • Hyperglycemia

    Hyperglycemia is a condition characterized by high levels of glucose in the blood. It commonly occurs in individuals with diabetes when insulin levels are insufficient or when the body cannot effectively use insulin. As glucose levels rise, symptoms such as increased thirst, frequent urination, and fatigue may develop. The progression of hyperglycemia depends on the underlying cause and the body's ability to regulate blood sugar levels. If not managed, it can lead to more severe health issues.

  • Hypoglycemia

    Hypoglycemia is a condition where blood sugar levels drop below normal. It often occurs in individuals with diabetes who take insulin or other glucose-lowering medications. As glucose levels fall, symptoms such as shakiness, sweating, confusion, and irritability may appear. The progression of hypoglycemia depends on the speed and extent of the drop in blood sugar levels. If not promptly addressed, it can lead to more severe neurological symptoms.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-520744-14-00Estimated enrolment640 patientsSponsorAntwerp University Hospital

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