Electrolyte Balance Effects of Sterofundin Versus Normal Saline in Diabetic Ketoacidosis

Universiti Sains Malaysia

Status: Enrolling

Conditions: Treatment Diabetic Ketoacidosis, Electrolyte Balance Effects

Treatments: Other: Sterofundin fluid therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT06399510

USM/JEPeM/KK/23100751

Details and patient eligibility

About

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.

Enrollment: 58 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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58 participants in 2 patient groups

Normal Saline

Active Comparator group

Description:

If patients were randomized to the control arm, the fluid regime for the first 24 hours in ICU will be normal saline.

Treatment:

Other: Sterofundin fluid therapy

Sterofundin

Experimental group

Description:

If patients were randomized to the interventional arm, the main fluid therapy during the first 24 hours of ICU stay will be Sterofundin.

Treatment:

Other: Sterofundin fluid therapy