An interventional study of Sterofundin fluid therapy in Treatment Diabetic Ketoacidosis, Electrolyte Balance Effects, sponsored by Universiti Sains Malaysia. Recruiting at 1 site in Malaysia. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-05-03.
Sponsored by Universiti Sains Malaysia · Not applicable, Interventional, and Treatment
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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.
76 studies on the registry are indexed under Diabetic Ketoacidosis; 17 are open to participants now.
This study's planned enrollment of 58 is below the median of 66 across 44 interventional studies indexed under Diabetic Ketoacidosis.
Browse Diabetic Ketoacidosis studies →Universiti Sains Malaysia is the lead sponsor of 177 studies on the registry; 51 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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Exclusion Criteria:
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
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.
The duration taken for serum HCO3 ≥ 15 within 24 hours ICU admission.
Time frame: 24 Hours
Mean difference of serum sodium level between Sterofundin and normal saline fluid use in diabetic ketoacidosis patients
Time frame: 24 Hours
Mean difference of serum potassium level between Sterofundin and normal saline fluid use in diabetic ketoacidosis patients.
Time frame: 24 Hours
The Need of Renal Replacement Therapy
Time frame: 30 days
Mechanical ventilation day
Time frame: 30 days
Plan to share: No
No publications or documents are linked to this record.
Started Mar 2024 (actual). Primary completion is estimated for Mar 2025, 12 months after the start.
Of 16 interventional studies with no phase under Diabetic Ketoacidosis, half reached primary completion within 13 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 15. This study's planned 12 months is close to that.
How these figures are worked out, and which studies are left out of them.
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