Electrolyte Balance Effects of Sterofundin Versus Normal Saline in Diabetic Ketoacidosis

April 30, 2024 updated by: Mohd Zulfakar Mazlan, MBBS, Universiti Sains Malaysia

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

58

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Malaysia
    • Kelantan
      • Kubang Kerian, Kelantan, Malaysia, 16150
        • Recruiting
        • Hospital Universiti Sains Malaysia
        • Contact:
          • MOHD ZULFAKAR BIN MAZLAN, Master
          • Phone Number: 6104 +6097673000
          • Email: zulfakar@usm.my
        • Principal Investigator:
          • JIE SHI HOW, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Normal Saline
If patients were randomized to the control arm, the fluid regime for the first 24 hours in ICU will be normal saline.
Other: Sterofundin fluid therapy
Sterofundin is known as balanced solution which has similar electrolytes content as per human plasma.
Experimental: Sterofundin
If patients were randomized to the interventional arm, the main fluid therapy during the first 24 hours of ICU stay will be Sterofundin.
Other: Sterofundin fluid therapy
Sterofundin is known as balanced solution which has similar electrolytes content as per human plasma.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
The Need of Renal Replacement Therapy
Time Frame: 30 days
30 days
Mechanical ventilation day
Time Frame: 30 days
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universiti Sains Malaysia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2024

Primary Completion (Estimated)

March 31, 2025

Study Completion (Estimated)

April 30, 2025

Study Registration Dates

First Submitted

April 30, 2024

First Submitted That Met QC Criteria

April 30, 2024

First Posted (Actual)

May 3, 2024

Study Record Updates

Last Update Posted (Actual)

May 3, 2024

Last Update Submitted That Met QC Criteria

April 30, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • USM/JEPeM/KK/23100751

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe