Comparison of isotonic saline and Ringer lactate in the management of severe diabetic ketoacidosis: a double-blind randomized controlled trial.

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-511513-37-00

Acronym

22-API-03

Enrollment

300

Registered

2025-01-10

Start date

2025-10-23

Completion date

Unknown

Last updated

2025-01-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic keto-acidosis

Brief summary

Resolution of ketoacidosis allowing discharge from ICU, defined as the proportion of patients with the following three criteria at 24 hours from ICU admission : 1. capillary or blood glucose < 11 mmol/L 2. undetectable ketonemia or ketonuria 3. venous or arterial pH > 7.35 or venous or arterial bicarbonate > 20 mmol/L

Interventions

DRUGSODIUM CHLORIDE

DRUGSODIUM LACTATE

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Resolution of ketoacidosis allowing discharge from ICU, defined as the proportion of patients with the following three criteria at 24 hours from ICU admission : 1. capillary or blood glucose < 11 mmol/L 2. undetectable ketonemia or ketonuria 3. venous or arterial pH > 7.35 or venous or arterial bicarbonate > 20 mmol/L	—

Countries

France

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026