Ignite Creation Date:
2024-05-06 @ 8:27 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06399510
Status:
RECRUITING
Last Update Posted:
2024-05-03
First Post:
2024-04-30
Brief Title:
Electrolyte Balance Effects of Sterofundin Versus Normal Saline in Diabetic Ketoacidosis
Sponsor:
Universiti Sains Malaysia
Organization:
Universiti Sains Malaysia
Study Overview
Official Title:
Electrolyte Balance Effects of Sterofundin Versus Normal Saline in Diabetic Ketoacidosis
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 15mmolL 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 11 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
i Is there any difference in duration of bicarbonate HCO3- to reach equal or more than 15mmolL 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 11 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None