Comparing Sterofundin and Normal Saline for Diabetic Ketoacidosis Treatment
Electrolyte Balance Effects of Sterofundin Versus Normal Saline in Diabetic Ketoacidosis
This study is testing whether using Sterofundin instead of Normal Saline helps people with Diabetic Ketoacidosis keep their electrolytes balanced better during their first day in the ICU.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 58 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Universiti Sains Malaysia Academic / other |
| Locations | 1 site (Kubang Kerian, Kelantan) |
| Trial ID | NCT06399510 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effects of Sterofundin compared to Normal Saline on electrolyte balance in patients with Diabetic Ketoacidosis (DKA). It is a prospective, single-centered, randomized control trial where participants will be assigned to receive either Sterofundin or Normal Saline as their primary fluid therapy during the first 24 hours of ICU stay. The study will measure the duration for bicarbonate levels to reach a specific threshold and assess post-infusion serum sodium and potassium levels. The goal is to determine if there are significant differences in electrolyte balance between the two fluid therapies.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older who are admitted to the ICU with Diabetic Ketoacidosis within 12 hours of initial fluid resuscitation.
Not a fit: Patients with end-stage renal failure, heart failure, or those who have received sodium bicarbonate infusion prior to ICU admission may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management of electrolyte balance in DKA patients, potentially enhancing recovery outcomes.
How similar studies have performed: While there have been studies on fluid management in DKA, the specific comparison of Sterofundin and Normal Saline is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Kubang Kerian, Kelantan
- Hospital Universiti Sains Malaysia — Kubang Kerian, Kelantan, Malaysia (Recruiting)
Study contacts
- Study coordinator: Shi Jie How
- Email: shijie.how@gmail.com
- Phone: +601151362495
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.