Treatment Diabetic Ketoacidosis, Electrolyte Balance Effects
Conditions
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.
Interventions
OTHERSterofundin fluid therapy
Sterofundin is known as balanced solution which has similar electrolytes content as per human plasma.
Sponsors
Universiti Sains Malaysia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The duration taken for serum HCO3 ≥ 15 within 24 hours ICU admission. | 24 Hours |
| Mean difference of serum sodium level between Sterofundin and normal saline fluid use in diabetic ketoacidosis patients | 24 Hours |
| Mean difference of serum potassium level between Sterofundin and normal saline fluid use in diabetic ketoacidosis patients. | 24 Hours |
Secondary
| Measure | Time frame |
|---|---|
| The Need of Renal Replacement Therapy | 30 days |
| Mechanical ventilation day | 30 days |
Countries
Malaysia
Contacts
Primary ContactShi Jie How
Outcome results
None listed