Electrolyte Balance Effects of Sterofundin Versus Normal Saline in Diabetic Ketoacidosis

Not Applicable

Recruiting

• Conditions: Treatment Diabetic Ketoacidosis, Electrolyte Balance Effects

• Registration Number: NCT06399510
• Lead Sponsor: Universiti Sains Malaysia

Brief Summary

The goal of this prospective single centered randomized control trial is to compare the electrolyte balance effects between Sterofundin and Normal Saline in Diabetic Ketoacidosis patients. The main questions it aims to answer are:

i. Is there any difference in duration of bicarbonate (HCO3-) to reach equal or more than 15mmol/L from the initial blood taking in between Sterofundin and NS fluid use in DKA patients? ii. Is there any difference in the level of post-infusion serum sodium (Na+) between Sterofundin and NS fluid use in DKA patients? iii. Is there any difference in the level of post-infusion serum potassium (K+) between Sterofundin and NS fluid use in DKA patients?

Patients will be randomized in a 1:1 ratio to receive IV Sterofundin (intervention) or IV Normal Saline (standard care). The patient will have the respective fluid regime as the main fluid therapy during the first 24 hours of ICU stay. If patients were randomized to the control arm, the fluid regime for the first 24 hours in ICU will be normal saline. If patients were randomized to the interventional arm, the main fluid therapy during the first 24 hours of ICU stay will be Sterofundin.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-03-01
• Status Verified: 2024-04
• Study First Submitted: 2024-04-30
• Study First Submitted QC: 2024-04-30
• Last Update Submitted: 2024-04-30
• Study First Posted: 2024-05-03
• Last Update Posted: 2024-05-03
• Primary Completion: 2025-03-31
• Study Completion: 2025-04-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 58

Inclusion Criteria

• DKA.
• Aged ≥ 18 years old.
• Patients admitted to ICU < 12 hours after initial fluid resuscitation from emergency department/ ward.

Exclusion Criteria

• End stage renal failure
• Heart failure
• Started treatment of sodium bicarbonate infusion prior to ICU admission
• Known allergy to Sterofundin

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Mean difference of serum sodium level between Sterofundin and normal saline fluid use in diabetic ketoacidosis patients	24 Hours
Mean difference of serum potassium level between Sterofundin and normal saline fluid use in diabetic ketoacidosis patients.	24 Hours
The duration taken for serum HCO3 ≥ 15 within 24 hours ICU admission.	24 Hours

Secondary Outcome Measures

Name	Time	Method
The Need of Renal Replacement Therapy	30 days
Mechanical ventilation day	30 days

Trial Locations

Locations (1)

Hospital Universiti Sains Malaysia; 🇲🇾 Kubang Kerian, Kelantan, Malaysia