NCT06399510

Electrolyte Balance Effects of Sterofundin Versus Normal Saline in Diabetic Ketoacidosis

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 58 (estimated)
• Sponsor: Universiti Sains Malaysia · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Treatment Diabetic Ketoacidosis, Electrolyte Balance Effects

Interventions

Type	Name	Description
OTHER	Sterofundin fluid therapy	Sterofundin is known as balanced solution which has similar electrolytes content as per human plasma.

Timeline

• Start date: 2024-03-01
• Primary completion: 2025-03-31
• Completion: 2025-04-30
• First posted: 2024-05-03
• Last updated: 2024-05-03

Locations

1 site across 1 country: Malaysia