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Recruiting NCT06541535

Fluid Administration in Ketoacidosis (DRINK)

Phase IV Interventional Diabetic Keto-acidosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Fluid resuscitation with isotonic saline only, Fluid resuscitation with Ringer Lactate.
Who it may be relevant to
Registry conditions: Diabetic Keto-acidosis. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Comparison of Saline and Ringer Lactate in Patients With Severe Diabetic Ketoacidosis (DRINK) : a Double-blind Randomized Controlled Trial

Overview

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.

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 : * 1
  • 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

Primary outcome measures

  • Resolution of diabetic ketoacidosis [Time frame: at 24 hours]
Secondary outcome measures (7)
  • Speed of resolution of metabolic disorders [Time frame: at 48 hours]
  • Time of resolution of metabolic disorders [Time frame: at 48 hours]
  • Assess the metabolic tolerance of Ringer Lactate compared to isotonic saline solution [Time frame: through the end of study average 24 months]
  • Assess the impact of Ringer lactate compared with isotonic saline on renal, neurological and cardiac complications [Time frame: at 28 days]
  • Assess the impact of Ringer lactate compared with isotonic saline on cardiac complications [Time frame: at 28 days]
  • Assess the impact of Ringer lactate compared with isotonic saline on renal complications [Time frame: at 28 days]
  • Assess the impact of Ringer lactate compared with isotonic saline on neurological complications [Time frame: at 28 days]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

France · 1 center
  • CHU NICE — Nice

Identifiers

NCT: NCT06541535 · 22-API-03

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗