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Completed

NCT Number: NCT02994316

Plasma Copeptin Levels in 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.

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Key information

Age range

6 month–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University hospital Montpellier

Montpellier, 34295, France

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Copeptine dosage in children with diabetic ketoacidosis at diagnosis

Other

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 outcomes

  1. Interest of copeptin dosage as a severity marker in children under the age of 16 with diabatic ketoacidosis

    Time frame: 36 hours

    Study of correlation between copeptin levels and metabolic acidosis management of diabatic ketoacidosis in children

Secondary outcomes

  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: 36 hours

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

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Registry information

Official study title

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

Acronym: COPACD

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Dec 15, 2016
Registry last updated
Oct 31, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.