Fluid Administration in Ketoacidosis (DRINK)

NCT ID: NCT06541535

Last Updated: 2024-08-07

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-31
• Study Completion Date: 2027-07-31

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 (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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Isotonic saline

Group Type: ACTIVE_COMPARATOR

Fluid resuscitation with isotonic saline only

Intervention Type: DRUG

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

Ringer Lactate

Group Type: EXPERIMENTAL

Fluid resuscitation with Ringer Lactate

Intervention Type: DRUG

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

Interventions

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

Intervention Type: 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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Admission to emergency department or direct admission to ICU
• Diagnosis of severe diabetic ketoacidosis requiring all the following criteria:
• Blood or capillary glucose > 11 mmol/L
• Ketonemia or ketonuria > 0
• Venous or arterial pH < 7.30 or venous or arterial bicarbonate < 15 mmol/L
• Volume of fluid administered before inclusion <1L

Exclusion Criteria

• Patients <18 years
• Pregnant women
• Patients under protection
• Patients with a decision to withdraw life-sustaining therapy
• Contraindication to isotonic saline or Ringer Lactate
• Non-affiliation to social security

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire de Nice

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CHU NICE

Nice, , France

Countries

France

Central Contacts

Mathieu JOZWIAK, MD PhD

Role: CONTACT

jozwiak.m@chu-nice.fr

+33492035510

Facility Contacts

MATHIEU JOZWIAK, MD PhD

Role: primary

jozwiak.m@chu-nice.fr

+33492035510

Other Identifiers

22-API-03

Identifier Type: -

Identifier Source: org_study_id