0.9% Saline Versus Balanced Solutions in Severe Diabetic Ketoacidosis

Phase 4

Completed

• Conditions: Acetonuria; Acetonemia; Ketoacidemia; Metabolic Ketoacidosis
• Interventions: Drug: Ringer lactate (RL); Drug: Sodium chloride 0.9% (SC)

• Registration Number: NCT05808972
• Lead Sponsor: Tunis University

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.

Detailed Description

We design an open randomized trial in adult patients admitted to our ICU for severe DKA. The insulin therapy protocol was identical and the randomization concerned the rehydration solution either by SC or RL. The primary endpoint was resolution of DKA at H48 defined by a composite endpoint (glycemia \<11 mmol/l, bicarbonates \> 15 mmol/l or pH\>7.30 and anion gap \<16). The secondary endpoints were resolution of DKA at H24, change in base excess to ≥ -3 meq/L at 48 h and H24 and change in electrolytes, insulin requirements, length of stay and mortality. Blood gases, ionogram with chloride and lactate were performed at baseline, H6, H12, H24 and H48.

Study Timeline

• Study Start: 2022-11-01
• Study First Submitted: 2023-03-16
• Study First Submitted QC: 2023-04-11
• Study First Posted: 2023-04-12
• Primary Completion: 2023-12-30
• Study Completion: 2023-12-30
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-11
• Last Update Posted: 2024-04-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 92

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ringer lactate (RL) arm	Ringer lactate (RL)	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.
Sodium chloride 0.9% (SC) arm	Sodium chloride 0.9% (SC)	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.

Primary Outcome Measures

Name	Time	Method
Number of participants with composite endpoint achievement	48 hours from inclusion	composite endpoint (glycemia \<11 mmol/l, bicarbonates \>15 mmol/l or pH \>7.30 and anion gap \<16).

Secondary Outcome Measures

Name	Time	Method
Number of participants with hyperchloremia	at 48 hours from inclusion	chlore level \> 105 mmol/L
change in base excess to ≥ -3 meq/L	at 48 hours and at 24 hours from inclusion	to ≥ -3 meq/L
Total insulin dose received	through study completion, an average of 9 months	insulin dose prescribed during treatment

Trial Locations

Locations (1)

Ahlem Trifi; 🇹🇳 Tunis, Tunisia