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Study Comparing Sodium Chloride and Sodium Lactate for Treating Severe Diabetic Ketoacidosis in ICU Patients

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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 treatment of diabetic ketoacidosis, a serious condition that can occur in people with diabetes when the body starts breaking down fats too quickly. The study will compare two different fluids used for treatment: sodium chloride (also known as isotonic saline) and sodium lactate (also known as Ringer lactate). These fluids are given through an infusion, which means they are delivered directly into the bloodstream through a vein.

The purpose of the study is to see which fluid is more effective in helping patients recover from severe diabetic ketoacidosis within 24 hours of being admitted to the Intensive Care Unit (ICU). Participants in the study will receive one of the two fluids, and their progress will be monitored to determine how quickly their condition improves. The study is designed to be double-blind, meaning neither the patients nor the healthcare providers will know which fluid is being administered, to ensure unbiased results.

Throughout the study, the main goal is to observe the resolution of ketoacidosis, which is when the patient's blood sugar levels return to normal, ketones are no longer present in the blood or urine, and the blood's acidity is corrected. This trial aims to provide valuable information on the best fluid treatment for managing severe diabetic ketoacidosis, potentially improving care for patients with this condition in the future.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Admission and initial assessment

    Upon admission to the emergency department or direct admission to the Intensive Care Unit (ICU), an initial assessment is conducted to confirm the diagnosis of severe diabetic ketoacidosis.

    The diagnosis requires a blood or capillary glucose level greater than 11 mmol/L, ketonemia or ketonuria greater than 0, and a venous or arterial pH less than 7.30 or venous or arterial bicarbonate less than 15 mmol/L.

    It is also confirmed that the volume of fluid administered before inclusion is less than 1 liter.

  2. Step 2

    Randomization and treatment initiation

    Participants are randomly assigned to receive either isotonic saline or Ringer lactate through infusion.

    The objective is to compare the effectiveness of these fluids in resolving diabetic ketoacidosis within 24 hours of ICU admission.

  3. Step 3

    Monitoring and evaluation

    Throughout the treatment, continuous monitoring of blood glucose levels, ketone levels, and pH or bicarbonate levels is conducted.

    The primary goal is to achieve resolution of ketoacidosis, allowing for discharge from the ICU. This is defined by meeting the following criteria within 24 hours: capillary or blood glucose less than 11 mmol/L, undetectable ketonemia or ketonuria, and venous or arterial pH greater than 7.35 or venous or arterial bicarbonate greater than 20 mmol/L.

  4. Step 4

    Completion and discharge

    Once the criteria for resolution of ketoacidosis are met, the patient is considered for discharge from the ICU.

    The trial aims to conclude by February 28, 2027, with recruitment starting on January 20, 2025.

Who can join the trial?

7 criteria

  • Must be admitted to the emergency department or directly to the Intensive Care Unit (ICU).
  • Must have a diagnosis of severe diabetic ketoacidosis. This means:
    • Blood or capillary glucose level greater than 11 mmol/L. This is a measure of sugar in the blood.
    • Ketonemia or ketonuria greater than 0. This means there are ketones in the blood or urine.
    • Venous or arterial pH less than 7.30 or venous or arterial bicarbonate less than 15 mmol/L. These are measures of acidity in the blood.
    • Must have received less than 1 liter of fluid before being included in the study.
    • Both male and female participants are eligible.
    • Participants from vulnerable populations are eligible.

Who cannot join the trial?

5 criteria

  • Patients who do not have severe diabetic ketoacidosis cannot participate. Diabetic ketoacidosis is a serious condition that can happen when blood sugar levels are very high, and the body starts breaking down fat for energy, leading to a buildup of acids called ketones in the blood.
  • Patients who are not admitted to the Intensive Care Unit (ICU) cannot participate. The ICU is a special department in a hospital where patients with severe or life-threatening illnesses are closely monitored and treated.
  • Patients who are not within the specified age range cannot participate. The study includes certain age groups, so patients must fall within these age categories.
  • Patients who are not part of the specified clinical trial groups cannot participate. The study is designed for specific groups of patients, and only those groups are eligible.
  • Patients who are not considered part of the vulnerable population selected for the study cannot participate. A vulnerable population refers to groups of people who might be at a higher risk of harm or exploitation in a study.
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Investigated drugs

  • Isotonic Saline

    is a type of fluid that is often used in medical settings to help restore the balance of fluids in the body. In this trial, it is being used to see how well it helps in treating severe diabetic ketoacidosis, a serious condition that can occur in people with diabetes.

  • Ringer Lactate

    is another type of fluid used in medical treatments. It contains a mix of water and electrolytes, which are important for maintaining the body's fluid balance. This trial is testing how effective Ringer Lactate is compared to isotonic saline in managing severe diabetic ketoacidosis.

What is already known about the treatment

  • Isotonic Saline

    Isotonic saline is administered intravenously and is commonly used in medical settings to restore fluid balance in the body. It is currently well-established in medical literature as a standard treatment for various conditions requiring fluid resuscitation. The main therapeutic indication for isotonic saline in this trial is the management of severe diabetic ketoacidosis. It works by replenishing lost fluids and electrolytes, helping to stabilize blood pressure and improve circulation. Isotonic saline is classified as a crystalloid solution in pharmacology.

  • Ringer Lactate

    Ringer lactate is also administered intravenously and is used to treat or prevent dehydration and electrolyte imbalances. It is widely recognized in medical literature as an effective fluid replacement therapy. In this clinical trial, its primary use is for the treatment of severe diabetic ketoacidosis. Ringer lactate helps by providing a balanced electrolyte solution that supports the body's natural functions and aids in the correction of acidosis. It is classified as a balanced crystalloid solution in pharmacological terms.

Investigated diseases

Diabetic Ketoacidosis – Diabetic ketoacidosis is a serious complication of diabetes that occurs when the body starts breaking down fats at a rapid rate. This process leads to the production of ketones, which are acids that accumulate in the blood and can cause the blood to become acidic. It typically develops when there is not enough insulin in the body, often triggered by illness or inadequate insulin therapy. Symptoms may include excessive thirst, frequent urination, nausea, abdominal pain, and confusion. If not addressed, it can lead to dehydration and an imbalance of electrolytes. The condition requires prompt medical attention to prevent further complications.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-511513-37-00Protocol code22-API-03Estimated enrolment300 patientsSponsorCentre Hospitalier Universitaire De Nice

sourced from the EU Clinical Trials Register and site verification

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