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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Normal Saline | Active Comparator | If patients were randomized to the control arm, the fluid regime for the first 24 hours in ICU will be normal saline. |
|
| Sterofundin | Experimental | If patients were randomized to the interventional arm, the main fluid therapy during the first 24 hours of ICU stay will be Sterofundin. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sterofundin fluid therapy | Other | Sterofundin is known as balanced solution which has similar electrolytes content as per human plasma. |
|
| Measure | Description | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| The Need of Renal Replacement Therapy | 30 days | |
| Mechanical ventilation day | 30 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shi Jie How | Contact | +601151362495 | shijie.how@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universiti Sains Malaysia | Recruiting | Kubang Kerian | Kelantan | 16150 | Malaysia |
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