Electrolyte Balance Effects of Sterofundin Versus Normal Saline in Diabetic Ketoacidosis

NCT ID: NCT06399510

Last Updated: 2024-05-03

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 58 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-01
• Study Completion Date: 2025-04-30

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.

Conditions

Treatment Diabetic Ketoacidosis, Electrolyte Balance Effects

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Normal Saline

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

Group Type: ACTIVE_COMPARATOR

Sterofundin fluid therapy

Intervention Type: OTHER

Sterofundin is known as balanced solution which has similar electrolytes content as per human plasma.

Sterofundin

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

Group Type: EXPERIMENTAL

Sterofundin fluid therapy

Intervention Type: OTHER

Sterofundin is known as balanced solution which has similar electrolytes content as per human plasma.

Interventions

Sterofundin fluid therapy

Sterofundin is known as balanced solution which has similar electrolytes content as per human plasma.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universiti Sains Malaysia

OTHER

Sponsor Role: lead

Responsible Party

Mohd Zulfakar Mazlan, MBBS

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Hospital Universiti Sains Malaysia

Kubang Kerian, Kelantan, Malaysia

Site Status: RECRUITING

Countries

Malaysia

Central Contacts

Shi Jie How

Role: CONTACT

shijie.how@gmail.com

+601151362495

Facility Contacts

MOHD ZULFAKAR BIN MAZLAN, Master

Role: primary

zulfakar@usm.my

+6097673000 ext. 6104

Other Identifiers

USM/JEPeM/KK/23100751

Identifier Type: -

Identifier Source: org_study_id