Clinical trial

0.9% Sodium Chloride Versus Ringer's Lactate in the Treatment of Severe Diabetic Ketoacidosis: a Randomized Trial

Name

Rabta-ICU

Description

Severe diabetic ketoacidosis (DKA) is a potentially serious complication of diabetes mellitus. The treatment regimen is based on insulin and rehydration. The choice of rehydration solution is a question that remains open. We sought to compare the effect of sodium chloride 0.9% (SC) versus ringer lactate (RL) in the resolution of severe DKA as well as on the variation of electrolytes.

Trial arms

Trial start

2022-11-01

Estimated PCD

2023-12-30

Trial end

2023-12-30

Status

Completed

Phase

Early phase I

Treatment

Sodium chloride 0.9% (SC)

This trial looks specifically at the type of hydratation liquid. The patients included will receive SC. The volume, frequency of fluid administration and other severe DKA therapies, such as insulin therapy and electrolytes, are prescribed similarly. The intervention will continue for 48 hours from admission to the ICU with a blood gas control (including base excess) + Blood glucose + ionogram (Na, K, chlorine) + lactates on admission (or H0), H6, H12, H24 and H48.

Arms:

Sodium chloride 0.9% (SC) arm

Other names:

Hydration solution

Ringer lactate (RL)

The intervention will continue for 48 hours from admission to the ICU with a blood gas control (including base excess) + Blood glucose + ionogram (Na, K, chlorine) + lactates on admission (or H0), H6, H12, H24 and H48.

Arms:

Ringer lactate (RL) arm

Other names:

Hydration solution

Size

Primary endpoint

Number of participants with composite endpoint achievement

48 hours from inclusion

Eligibility criteria

Inclusion Criteria: - All patients aged 16 and over hospitalized in intensive care for severe ketoacidosis defined as arterial pH ≤ 7.25 (or serum bicarbonate ≤ 15 mmol/L) and blood glucose ≥ 14 mmol/L and need for ICU. Exclusion Criteria: * \< 16 Y

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Independant groups included by randomisation', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}}, 'enrollmentInfo': {'count': 92, 'type': 'ACTUAL'}}

Updated at

2024-04-12

1 organization

2 products

4 indications

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Indication

Indication

Indication

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