Clinical Trial: Plasma Copeptin Levels in Children With Diabetic Ketoacidosis

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

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 Summary:

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.


Sponsor: University Hospital, Montpellier

Current Primary Outcome: Interest of copeptin dosage as a severity marker in children under the age of 16 with diabatic ketoacidosis [ Time Frame: 30 months ]

Study of correlation between copeptin levels and metabolic acidosis in the first 36 hours management of diabatic ketoacidosis in children


Original Primary Outcome: Same as current

Current Secondary Outcome: 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 [ Time Frame: 30 months ]

Interest of copeptin dosage as a new marker of diabatic ketoacidosis severy compared to other used markers


Original Secondary Outcome: Same as current

Information By: University Hospital, Montpellier

Dates:
Date Received: November 28, 2016
Date Started: October 2016
Date Completion: December 2018
Last Updated: December 12, 2016
Last Verified: September 2016