0.9% Saline Versus Balanced Solutions in Severe Diabetic Ketoacidosis

NCT05808972 | Completed Phase 4

• 1 other identifier: Rabta-ICU
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Metabolic Ketoacidosis; Ketoacidemia; Acetonemia; Acetonuria

Keywords

Severe diabetic ketoacidosis,; Sodium chloride 0.9%; Ringer lactate; Base excess

Outcome Measures

Primary Outcomes (1)

• Number of participants with composite endpoint achievement

  composite endpoint (glycemia \<11 mmol/l, bicarbonates \>15 mmol/l or pH \>7.30 and anion gap \<16).

  48 hours from inclusion

Secondary Outcomes (3)

• change in base excess to ≥ -3 meq/L

  at 48 hours and at 24 hours from inclusion

• Number of participants with hyperchloremia

  at 48 hours from inclusion

• Total insulin dose received

  through study completion, an average of 9 months

Study Arms (2)

Sodium chloride 0.9% (SC) arm

ACTIVE COMPARATOR

The SC arm receives insulin therapy via an electric syringe (Actrapid HM ®, Novorapide®) (1 ml = 100 IU) - take 0.5 ml (= 40 IU) and complete to 50 ml with SC to obtain a solution of 1 ml = 1 IU. -Infusion rate = 0.1 IU/kg/h. In parallel, and on an insulin-independent route, 0.9% chloride saline is started on the basis of 3 L/ 24 hours per day if capillary glyceamia\>2,5 g/l . Blood samples were taken for glycemia, arterial Blood gas, electrolytes, lactate at baseline, 6, 12, 24 and 48 hours later.

Drug: Sodium chloride 0.9% (SC)

Ringer lactate (RL) arm

ACTIVE COMPARATOR

The SC arm receives insulin therapy via an electric syringe (Actrapid HM ®, Novorapide®) (1 ml = 100 IU) - take 0.5 ml (= 40 IU) and complete to 50 ml with SC to obtain a solution of 1 ml = 1 IU. -Infusion rate = 0.1 IU/kg/h. In parallel, and on an insulin-independent route, Ringer lactate is started on the basis of 3 L/ 24 hours per day if capillary glyceamia\>2,5 g/l . Blood samples were taken for glycemia, arterial Blood gas, electrolytes, lactate at baseline, 6, 12, 24 and 48 hours later.

Drug: Ringer lactate (RL)

Interventions

Sodium chloride 0.9% (SC) DRUG

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.

Also known as: Hydration solution

Sodium chloride 0.9% (SC) arm

Ringer lactate (RL) DRUG

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.

Also known as: Hydration solution

Ringer lactate (RL) arm

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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.

You may not qualify if:

• \< 16 Y

Sponsors & Collaborators

• Tunis University: lead

Study Sites (1)

Ahlem Trifi

Tunis, 1007, Tunisia

Location

Related Publications (1)

• Trifi A, Ben Braik I, Galai H, Azzouz N, Tlili B, Mehdi A, Messaoud L, Seghir E, Ouhibi A, Abdellatif S. 0.9% sodium chloride versus ringer's lactate in the management of severe diabetic ketoacidosis: A randomized trial. Med Intensiva (Engl Ed). 2025 Apr 14:502203. doi: 10.1016/j.medine.2025.502203. Online ahead of print.

  PMID: 40234173 DERIVED

MeSH Terms

Conditions

Ketosis; Diabetic Ketoacidosis

Interventions

Sodium Chloride; Ringer's Lactate

Condition Hierarchy (Ancestors)

Acidosis; Acid-Base Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Ahlem Trifi

  Rabta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Independant groups included by randomisation

Study Record Dates

• First Submitted: March 16, 2023
• First Posted: April 12, 2023
• Study Start: November 1, 2022
• Primary Completion: December 30, 2023
• Study Completion: December 30, 2023
• Last Updated: April 12, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)