Plasma Copeptin Levels in Children With Diabetic Ketoacidosis

Not Applicable

Completed

• Conditions: Diabetic Ketoacidosis Children
• Interventions: Other: Copeptine dosage in children with diabetic ketoacidosis at diagnosis

• Registration Number: NCT02994316
• Lead Sponsor: University Hospital, Montpellier

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.

Study Timeline

• Study Start: 2016-10-03
• Study First Submitted: 2016-11-28
• Study First Submitted QC: 2016-12-12
• Study First Posted: 2016-12-15
• Primary Completion: 2018-11-23
• Study Completion: 2018-11-25
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-30
• Last Update Posted: 2019-10-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 58

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
children under the age of 16 diabete with ketoacidosis	Copeptine dosage in children with diabetic ketoacidosis at diagnosis	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)
children under the age of 16 diabete without ketoacidosis	Copeptine dosage in children with diabetic ketoacidosis at diagnosis	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)

Primary Outcome Measures

Name	Time	Method
Interest of copeptin dosage as a severity marker in children under the age of 16 with diabatic ketoacidosis	36 hours	Study of correlation between copeptin levels and metabolic acidosis management of diabatic ketoacidosis in children

Secondary Outcome Measures

Name	Time	Method
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	36 hours	Interest of copeptin dosage as a new marker of diabatic ketoacidosis severy compared to other used markers

Trial Locations

Locations (1)

University hospital Montpellier; 🇫🇷 Montpellier, France