Recruiting soon

DRINKSaline vs. Ringer Lactate for Severe Diabetic Ketoacidosis

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What is being tested

Fluid resuscitation with isotonic saline only

+ Fluid resuscitation with Ringer Lactate

Drug
Who is being recruted

Over 18 Years
+12 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 4
Interventional
Study Start: December 2024
See protocol details

Summary

Principal SponsorCentre Hospitalier Universitaire de Nice
Study ContactMathieu JOZWIAK, MD PhD
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: December 1, 2024

Actual date on which the first participant was enrolled.

This clinical trial is aimed at finding out whether using a solution called Ringer Lactate is more effective and safer than the commonly used isotonic saline for treating people with severe diabetic ketoacidosis. Diabetic ketoacidosis is a serious condition that occurs when the body starts breaking down fats at a rapid rate, leading to a buildup of acids in the bloodstream called ketones. Isotonic saline, though widely used, can sometimes lead to complications like an imbalance of acids and bases in the body or kidney problems. Ringer Lactate has a composition closer to the body's natural fluids, potentially offering a safer alternative. This study is important as it seeks to improve the treatment of diabetic ketoacidosis by possibly providing a better fluid option that reduces the risk of complications. In this study, participants with severe diabetic ketoacidosis will receive either Ringer Lactate or isotonic saline. The solutions are given as fluids through a vein, a common method known as fluid resuscitation. The trial is designed to carefully measure how quickly the diabetic ketoacidosis resolves in each group and to check for any side effects related to the fluids used. By comparing the two solutions in a controlled setting, the study aims to determine if Ringer Lactate can lead to faster recovery and fewer complications than isotonic saline. The goal is to provide clearer guidance on the best fluid choice for managing this condition.

Official TitleComparison of Saline and Ringer Lactate in Patients With Severe Diabetic Ketoacidosis (DRINK) : a Double-blind Randomized Controlled Trial
NCT06541535
Principal SponsorCentre Hospitalier Universitaire de Nice
Study ContactMathieu JOZWIAK, MD PhD
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

300 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

6 inclusion criteria required to participate
Admission to emergency department or direct admission to ICU

Diagnosis of severe diabetic ketoacidosis requiring all the following criteria:

Blood or capillary glucose > 11 mmol/L

Ketonemia or ketonuria > 0

Show More Criteria

6 exclusion criteria prevent from participating
Patients <18 years

Pregnant women

Patients under protection

Patients with a decision to withdraw life-sustaining therapy

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Active Comparator

Group II

Experimental

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

CHU NICE

Nice, FranceOpen CHU NICE in Google Maps
Recruiting soonOne Study Center