Plasma Copeptin Levels in Children With Diabetic Ketoacidosis

Diabetic Ketoacidosis Children Clinical Trial

— COPACD  

Official title:

Interest of Plasma Copeptin Levels in Management of Children With Diabetic Ketoacidosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02994316
• Other study ID #: 9649
• Status: Completed
• Phase: N/A
• Start date: October 3, 2016
• Est. completion date: November 25, 2018

Study information

• Verified date: October 2019
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: November 25, 2018
• Est. primary completion date: November 23, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Months to 16 Years

Eligibility

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

Related Conditions & MeSH terms

• Acidosis
• Diabetic Ketoacidosis
• Diabetic Ketoacidosis Children
• Ketosis

Intervention

Other:
• Copeptine dosage in children with diabetic ketoacidosis at diagnosis
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

Locations

Country	Name	City	State
France	University hospital Montpellier	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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