DRINKSaline vs. Ringer Lactate for Severe Diabetic Ketoacidosis
Fluid resuscitation with isotonic saline only
+ Fluid resuscitation with Ringer Lactate
Treatment Study
Summary
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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.300 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.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
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
Active ComparatorGroup II
ExperimentalStudy 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