Electrolyte Balance Effects of Sterofundin Versus Normal Saline in Diabetic Ketoacidosis
Launched by UNIVERSITI SAINS MALAYSIA · Apr 30, 2024
Trial Information
Current as of September 04, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying the effects of two different fluids, Sterofundin and Normal Saline, on patients with Diabetic Ketoacidosis (DKA), a serious condition that can occur in people with diabetes. The main goal is to see which fluid helps balance important electrolytes, like sodium and potassium, better over the first 24 hours in the Intensive Care Unit (ICU). Researchers want to find out if there’s a difference in how quickly patients’ bicarbonate levels improve and how sodium and potassium levels change after receiving either fluid.
To participate in this study, patients must be at least 18 years old and have been diagnosed with DKA. They should also be admitted to the ICU within 12 hours after starting initial treatment. However, patients with certain conditions, such as severe kidney failure or heart failure, or those who have already been treated with sodium bicarbonate before coming to the ICU, cannot join. If you are eligible and choose to participate, you will be randomly assigned to receive either Sterofundin or Normal Saline as your main treatment for the first day in the ICU. This trial is currently recruiting participants, and it aims to improve care for patients with DKA by understanding which fluid works better for electrolyte balance.
Gender
ALL
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
About Universiti Sains Malaysia
Universiti Sains Malaysia (USM) is a leading research university in Malaysia, renowned for its commitment to advancing scientific knowledge and innovation in the healthcare sector. As a clinical trial sponsor, USM leverages its multidisciplinary expertise and state-of-the-art facilities to conduct rigorous research aimed at improving patient outcomes and addressing pressing health challenges. The university fosters collaboration among researchers, medical professionals, and industry partners, ensuring that its clinical trials are conducted with the highest ethical standards and scientific integrity. Through its dedication to excellence in research and education, USM plays a pivotal role in shaping the future of healthcare both locally and globally.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Kubang Kerian, Kelantan, Malaysia
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported