Plasma Copeptin Levels in Children With Diabetic Ketoacidosis (COPACD)

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

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.

Study Overview

• Status: Completed
• Conditions: Diabetic Ketoacidosis Children
• Intervention / Treatment: Other: Copeptine dosage in children with diabetic ketoacidosis at diagnosis

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 Type: Interventional
• Enrollment (Actual): 58
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Montpellier, France, 34295
    • University Hospital Montpellier

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 16 years (CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: children under the age of 16 diabete with ketoacidosis; 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; 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
SHAM_COMPARATOR: children under the age of 16 diabete without ketoacidosis; 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; 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

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

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier
• Investigators: Study Director: GILLES GC CAMBONIE, PU PH, University Hospital, Montpellier

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 3, 2016
• Primary Completion (ACTUAL): November 23, 2018
• Study Completion (ACTUAL): November 25, 2018

Study Registration Dates

• First Submitted: November 28, 2016
• First Submitted That Met QC Criteria: December 12, 2016
• First Posted (ESTIMATE): December 15, 2016

Study Record Updates

• Last Update Posted (ACTUAL): October 31, 2019
• Last Update Submitted That Met QC Criteria: October 30, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Complications; Diabetes Mellitus; Acid-Base Imbalance; Acidosis; Ketosis; Diabetic Ketoacidosis
• Other Study ID Numbers: 9649

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO