RecruitingNot ApplicableNCT06399510

Electrolyte Balance Effects of Sterofundin Versus Normal Saline in Diabetic Ketoacidosis


Sponsor

Universiti Sains Malaysia

Enrollment

58 participants

Start Date

Mar 1, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria3

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

Exclusion Criteria4

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

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Interventions

OTHERSterofundin fluid therapy

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


Locations(1)

Hospital Universiti Sains Malaysia

Kubang Kerian, Kelantan, Malaysia

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NCT06399510