Plasma Copeptin Levels in Children With Diabetic Ketoacidosis

Study Overview
=================
Brief Summary
-----------------
Children with diabetic ketoacidosis risk neurological complications such as cerebral edema with high morbidity. To prevent cerebral edema, it is essential to control correction of hypovolemia, hyperglycemia and natremia. Markers usually used in management of diabetic ketoacidosis don't always permit an optimal care. Plasma copeptin levels reflect vasopressin secretion which is high in diabetic ketoacidosis. Therefore, monitoring of plasma copeptin levels could be of interest in children with diabetic ketoacidosis and risk of sévère neurological complications.

Detailed Description
-----------------
Biological risk factors for severe complications in diabetic ketoacidosis are described (high blood glucose level, metabolic acidosis, high blood urea nitrogen, hypernatremia) but their dosage and monitoring are not sufficient to distinguish high risks situations. Several studies suggest that vasopressin secretion is increased in diabetic ketoacidosis. This high level could be important in occurrence of cerebral edema. Monitoring of vasopressin levels could then have an interest in patients at risk of severe complications but reliability of copeptin dosage depend of collection conditions and its packaging. These conditions are difficult to ensure and copeptin dosage, which represent vasopressin secretion, is easier to perform. Copeptin dosage could then be a new biological marker, more accurate and specific, for an optimal management of diabetic ketoacidosis. This type of study has never been carried out neither in children nor in adults.

Official Title
-----------------
Interest of Plasma Copeptin Levels in Management of Children With Diabetic Ketoacidosis

Conditions
-----------------
Diabetic Ketoacidosis Children

Intervention / Treatment
-----------------
* Other: Copeptine dosage in children with diabetic ketoacidosis at diagnosis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Children between 6 months and 16 years Diagnosis of diabetes mellitus type 1 (cardinal syndrome, blood glucose level > 7 mmol/L in the fasted state or > 11 mmol/L not in fasted state, no signs for another type of diabetes mellitus) Children who need an exclusive intravenous rehydration for 36 hours Written informed consent of legal representative and of the child if possible Beneficiary of State Social Insurance Exclusion criteria: Child under the age of 6 months or older than 16 years Non exclusive intravenous réhydration for at least 36 hours Child moved from another institution and for whom an intravenous rehydration or insulin therapy have already begun Non type 1 diabetes mellitus Non affiliation to State Social Insurance

Ages Eligible for Study
-----------------
Minimum Age: 6 Months
Maximum Age: 16 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: children under the age of 16 diabete with ketoacidosis<br>At diagnosis mellitus type 1 (measure of blood glucose level) bicarbonate levels will be measured and children will included in the arm with ketoacidosis (bicarbonate < 15mmol/L) | Other: Copeptine dosage in children with diabetic ketoacidosis at diagnosis<br>* Blood collection of 3 mL for copeptin dosage will be taken at different times in the first hours of management of diabetic ketoacodosis in children under the age of 16 years<br>|
| Sham Comparator: children under the age of 16 diabete without ketoacidosis<br>At diagnosis mellitus type 1 (measure of blood glucose level) bicarbonate levels will be measured and children will included in the arm without ketoacodosis (bicarbonate> 15 mmol/L) | Other: Copeptine dosage in children with diabetic ketoacidosis at diagnosis<br>* Blood collection of 3 mL for copeptin dosage will be taken at different times in the first hours of management of diabetic ketoacodosis in children under the age of 16 years<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Interest of copeptin dosage as a severity marker in children under the age of 16 with diabatic ketoacidosis | Study of correlation between copeptin levels and metabolic acidosis management of diabatic ketoacidosis in children | 36 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation between plasma copeptin levels and other markers used in management of diabatic ketoacidosis in the first 36 hours after diagnosis- Plasma copeptin levels at diagnosis of diabate mellitus type 1 without ketoacidosis in children | Interest of copeptin dosage as a new marker of diabatic ketoacidosis severy compared to other used markers | 36 hours |