Fluid Administration in Ketoacidosis (DRINK)

PHASE4Not yet recruitingINTERVENTIONAL
Enrollment

300

Participants

Timeline

Start Date

December 31, 2024

Primary Completion Date

December 31, 2026

Study Completion Date

July 31, 2027

Conditions
Diabetic Keto-acidosis
Interventions
DRUG

Fluid resuscitation with isotonic saline only

"Isotonic saline only will be used for fluid resuscitation in the first 48 hours of treatment, according to the protocol of English guidelines:~* During the first hour of treatment:~ * In the event of systolic arterial hypotension (SAP\<90mmHg): administration of 500 mL over 15 minutes, renewable once, then administration of 1L over 1 hour.~ * In the absence of systolic arterial hypotension (SAP\>90mmHg): administration of 1L over 1 hour.~* Between 60 minutes and 8 hours of treatment :~ * 1L over 2 hours, repeated once, then 1L over 4 hours~ * Adjust fluid resuscitation according to clinical tolerance~* After the first 8 hours:~ * 1L over 4h then 1L over 6h~ * Clinical re-evaluation according to standard of care in participating centers"

DRUG

Fluid resuscitation with Ringer Lactate

"Ringer Lactate only will be used for fluid resuscitation in the first 48 hours of treatment, according to the protocol of English guidelines:~* During the first hour of treatment:~ * In the event of systolic arterial hypotension (SAP\<90mmHg): administration of 500 mL over 15 minutes, renewable once, then administration of 1L over 1 hour.~ * In the absence of systolic arterial hypotension (SAP\>90mmHg): administration of 1L over 1 hour.~* Between 60 minutes and 8 hours of treatment :~ * 1L over 2 hours, repeated once, then 1L over 4 hours~ * Adjust fluid resuscitation according to clinical tolerance~* After the first 8 hours:~ * 1L over 4h then 1L over 6h~ * Clinical re-evaluation according to standard of care in participating centers"

Trial Locations (1)

Unknown

CHU NICE, Nice

All Listed Sponsors
lead

Centre Hospitalier Universitaire de Nice

OTHER