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

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What is this study about?

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.

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 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 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 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 Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Centre Jean Perrin	Clermont Ferrand	France
Centre Hospitalier Universitaire De Lille	Lille	France

Other Sites

Site Name	City	Country
Centre Hospitalier Universitaire De Nimes	Nimes	France
Centre Hospitalier D Avignon	Avignon	France
Centre Hospitalier D’Antibes Juan Les Pins	Antibes	France
Centre Hospitalier De Cannes Simone Veil	Cannes	France
Centre Hospitalier Universitaire De Montpellier	Montpellier	France
Centre Hospitalier Universitaire De Nantes	Nantes	France
Centre Hospitalier Universitaire De Nice	Nice	France
Centre Hospitalier Lyon Sud	Pierre Benite	France
Hopital Beaujon	Clichy	France
Centre Hospitalier De Beziers	Beziers	France
Cpzxre Hczzcegljxw Iefkqajbqfsol Dr Fsaqjhghvnpnqncvkieml	Frejus	France
Cuzsvn Hmzcdfzikth Em Uwxengwltnctv Dx Ltnndvh	Limoges	France
Atqtqviahs Pcvaysqc Hqihtriw Du Mwkfoetnd	Marseille	France
Hqdlwpcw Ukhnhhgekzahqv Swucsamlba &zfzuaj Hwfwunb da Hjusczrhvou	STRASBOURG, Alsace	France

Trial status

Country	Status	Recruitment Start
France	Recruiting	20.01.2025

Trial locations

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.

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 ID:

2024-511513-37-00

Protocol code:

22-API-03

Trial Phase:

Therapeutic confirmatory (Phase III)

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?