Diabetic ketoacidosis Trials in Disease

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

This trial is investigating the best way to treat severe diabetic ketoacidosis in patients admitted to the Intensive Care Unit (ICU). Diabetic ketoacidosis is a dangerous complication that occurs when the body starts breaking down fats too quickly, leading to a buildup of acids called ketones in the blood.

Who can participate:

• Patients admitted to the emergency department or directly to the ICU
• Those diagnosed with severe diabetic ketoacidosis, which means having a blood sugar level greater than 11 mmol/L, detectable ketones in blood or urine, and blood acidity measures showing pH less than 7.30 or bicarbonate less than 15 mmol/L
• Patients who have received less than 1 liter of fluid before joining the study
• Both men and women are eligible

Who cannot participate:

• Patients without severe diabetic ketoacidosis
• Those not admitted to the ICU
• Patients outside the specified age range for the study
• Individuals not meeting the specific clinical trial group criteria

What the trial is studying:

The study compares two different intravenous fluids used to treat this condition: isotonic saline (also called sodium chloride) and Ringer lactate (also called sodium lactate). Both fluids are delivered directly into the bloodstream through a vein to help restore the body's fluid and electrolyte balance.

The trial is designed as a double-blind study, meaning neither patients nor healthcare providers know which fluid is being given. This approach ensures unbiased results. The main goal is to determine which fluid more effectively helps patients recover from severe diabetic ketoacidosis within 24 hours of ICU admission.

Investigational treatments:

Isotonic saline is a standard fluid commonly used in hospitals to restore fluid balance. It helps replenish lost fluids and electrolytes, stabilizing blood pressure and improving circulation. In this trial, researchers are evaluating how well it treats severe diabetic ketoacidosis.

Ringer lactate is a balanced electrolyte solution that provides water and important minerals to the body. It supports natural body functions and helps correct the blood acidity that occurs in diabetic ketoacidosis. The trial is testing whether it works better than isotonic saline for managing this condition.

Throughout the study, medical teams continuously monitor blood sugar levels, ketone levels, and blood acidity. Recovery is considered achieved when the patient's blood sugar drops below 11 mmol/L, ketones are no longer detectable, and blood acidity returns to normal levels (pH greater than 7.35 or bicarbonate greater than 20 mmol/L). Once these goals are met within 24 hours, the patient may be discharged from the ICU.