Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06541535
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-08
Brief Title:
Fluid Administration in Ketoacidosis DRINK
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Comparison of Saline and Ringer Lactate in Patients With Severe Diabetic Ketoacidosis DRINK a Double-blind Randomized Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DRINK
Brief Summary:
Management of severe diabetic ketoacidosis is based on insulin therapy correction of metabolic disorders and fluid resuscitation Current recommendations recommend the first-line use of isotonic saline whose composition is unbalanced rich in chloride and sodium compared with plasma Administration of large volumes of isotonic saline is associated with a risk of hyperchloremic metabolic acidosis and acute renal failure Balanced solutions eg Ringer Lactate are solutions with a more balanced electrolyte composition close to that of plasma They could therefore enable diabetic ketoacidosis to be resolved more quickly than isotonic saline due to a lower risk of hyperchloremic acidosis Preliminary data suggest a potential benefit of balanced solutions for fluid resuscitation of patients with severe diabetic ketoacidosis in terms of resolution of diabetic ketoacidosis but no randomized controlled double-blind study to date has compared balanced solution vs isotonic saline in this context
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None