Plasma Copeptin Levels in Children With Diabetic Ketoacidosis (COPACD)
Primary Purpose
Diabetic Ketoacidosis Children
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Copeptine dosage in children with diabetic ketoacidosis at diagnosis
Sponsored by
About this trial
This is an interventional supportive care trial for Diabetic Ketoacidosis Children
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
Sites / Locations
- University hospital Montpellier
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
children under the age of 16 diabete with ketoacidosis
children under the age of 16 diabete without ketoacidosis
Arm Description
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)
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)
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
Full Information
NCT ID
NCT02994316
First Posted
November 28, 2016
Last Updated
October 30, 2019
Sponsor
University Hospital, Montpellier
1. Study Identification
Unique Protocol Identification Number
NCT02994316
Brief Title
Plasma Copeptin Levels in Children With Diabetic Ketoacidosis
Acronym
COPACD
Official Title
Interest of Plasma Copeptin Levels in Management of Children With Diabetic Ketoacidosis
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
October 3, 2016 (Actual)
Primary Completion Date
November 23, 2018 (Actual)
Study Completion Date
November 25, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Montpellier
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Ketoacidosis Children
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
58 (Actual)
8. Arms, Groups, and Interventions
Arm Title
children under the age of 16 diabete with ketoacidosis
Arm Type
Experimental
Arm Description
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)
Arm Title
children under the age of 16 diabete without ketoacidosis
Arm Type
Sham Comparator
Arm Description
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)
Intervention Type
Other
Intervention Name(s)
Copeptine dosage in children with diabetic ketoacidosis at diagnosis
Intervention Description
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
Primary Outcome Measure Information:
Title
Interest of copeptin dosage as a severity marker in children under the age of 16 with diabatic ketoacidosis
Description
Study of correlation between copeptin levels and metabolic acidosis management of diabatic ketoacidosis in children
Time Frame
36 hours
Secondary Outcome Measure Information:
Title
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
Description
Interest of copeptin dosage as a new marker of diabatic ketoacidosis severy compared to other used markers
Time Frame
36 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GILLES GC CAMBONIE, PU PH
Organizational Affiliation
University Hospital, Montpellier
Official's Role
Study Director
Facility Information:
Facility Name
University hospital Montpellier
City
Montpellier
ZIP/Postal Code
34295
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
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Plasma Copeptin Levels in Children With Diabetic Ketoacidosis
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