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0.9% Saline Versus Balanced Solutions in Severe Diabetic Ketoacidosis

Primary Purpose

Metabolic Ketoacidosis, Ketoacidemia, Acetonemia

Status
Recruiting
Phase
Phase 4
Locations
Tunisia
Study Type
Interventional
Intervention
Sodium chloride 0.9% (SC)
Ringer lactate (RL)
Sponsored by
Tunis University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metabolic Ketoacidosis focused on measuring Severe diabetic ketoacidosis,, Sodium chloride 0.9%, Ringer lactate, Base excess

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ahlem TrifiRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Sodium chloride 0.9% (SC) arm

Ringer lactate (RL) arm

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

change in base excess to ≥ -3 meq/L
to ≥ -3 meq/L
Number of participants with hyperchloremia
chlore level > 105 mmol/L
Total insulin dose received
insulin dose prescribed during treatment

Full Information

First Posted
March 16, 2023
Last Updated
October 20, 2023
Sponsor
Tunis University
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1. Study Identification

Unique Protocol Identification Number
NCT05808972
Brief Title
0.9% Saline Versus Balanced Solutions in Severe Diabetic Ketoacidosis
Official Title
0.9% Sodium Chloride Versus Ringer's Lactate in the Treatment of Severe Diabetic Ketoacidosis: a Randomized Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2022 (Actual)
Primary Completion Date
December 30, 2023 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tunis University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Ketoacidosis, Ketoacidemia, Acetonemia, Acetonuria
Keywords
Severe diabetic ketoacidosis,, Sodium chloride 0.9%, Ringer lactate, Base excess

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Independant groups included by randomisation
Masking
Participant
Allocation
Randomized
Enrollment
92 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Sodium chloride 0.9% (SC) arm
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Ringer lactate (RL) arm
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Sodium chloride 0.9% (SC)
Other Intervention Name(s)
Hydration solution
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Ringer lactate (RL)
Other Intervention Name(s)
Hydration solution
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of participants with composite endpoint achievement
Description
composite endpoint (glycemia <11 mmol/l, bicarbonates >15 mmol/l or pH >7.30 and anion gap <16).
Time Frame
48 hours from inclusion
Secondary Outcome Measure Information:
Title
change in base excess to ≥ -3 meq/L
Description
to ≥ -3 meq/L
Time Frame
at 48 hours and at 24 hours from inclusion
Title
Number of participants with hyperchloremia
Description
chlore level > 105 mmol/L
Time Frame
at 48 hours from inclusion
Title
Total insulin dose received
Description
insulin dose prescribed during treatment
Time Frame
through study completion, an average of 9 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Trifi
Phone
98692699
Email
trifiahlem2@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahlem Trifi
Organizational Affiliation
Rabta
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ahlem Trifi
City
Tunis
ZIP/Postal Code
1007
Country
Tunisia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ahlem Trifi
Phone
98692699
Email
trifiahlem2@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

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0.9% Saline Versus Balanced Solutions in Severe Diabetic Ketoacidosis

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