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Fluid Administration in Ketoacidosis (DRINK)

NCT06541535 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2024-08-07

No results posted yet for this study

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 (e.g. 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.

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

Sponsors & Collaborators

  • Centre Hospitalier Universitaire de Nice

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-31
Primary Completion
2026-12-31
Completion
2027-07-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06541535 on ClinicalTrials.gov