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Plasma Copeptin Levels in Children With Diabetic Ketoacidosis (COPACD)

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ClinicalTrials.gov Identifier: NCT02994316
Recruitment Status : Recruiting
First Posted : December 15, 2016
Last Update Posted : December 15, 2016
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Diabetic Ketoacidosis Children Other: Copeptine dosage in children with diabetic ketoacidosis at diagnosis Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 58 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Interest of Plasma Copeptin Levels in Management of Children With Diabetic Ketoacidosis
Study Start Date : October 2016
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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



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Ages Eligible for Study:   6 Months to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02994316


Contacts
Contact: Julie JT TENENBAUM, PH 33(0)467336428 j-tenenbaum@chu-montpellier.fr

Locations
France
University hospital Montpellier Recruiting
Montpellier, France, 34295
Contact: JULIE JT TENENBAUM, PH    33(0)467337123    j-tenenbaum@chu-montpellier.fr   
Sponsors and Collaborators
University Hospital, Montpellier
Investigators
Study Director: GILLES GC CAMBONIE, PU PH University Hospital, Montpellier

Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT02994316     History of Changes
Other Study ID Numbers: 9649
First Posted: December 15, 2016    Key Record Dates
Last Update Posted: December 15, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Diabetic Ketoacidosis
Ketosis
Acidosis
Acid-Base Imbalance
Metabolic Diseases
Diabetes Mellitus
Glucose Metabolism Disorders
Diabetes Complications
Endocrine System Diseases
Arginine Vasopressin
Hemostatics
Coagulants
Vasoconstrictor Agents
Antidiuretic Agents
Natriuretic Agents
Physiological Effects of Drugs