Plasma Copeptin Levels in Children With Diabetic Ketoacidosis
Nyckelord
Abstrakt
Beskrivning
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.
Datum
| Senast verifierad: | 09/30/2019 |
| Först skickat: | 11/27/2016 |
| Beräknad anmälan inlämnad: | 12/11/2016 |
| Först publicerad: | 12/14/2016 |
| Senaste uppdatering skickad: | 10/29/2019 |
| Senaste uppdatering publicerad: | 10/30/2019 |
| Faktiskt startdatum för studien: | 10/02/2016 |
| Uppskattat primärt slutdatum: | 11/22/2018 |
| Beräknat slutfört datum: | 11/24/2018 |
Tillstånd eller sjukdom
Intervention / behandling
Other: Copeptine dosage in children with diabetic ketoacidosis at diagnosis
Fas
Armgrupper
| Ärm | Intervention / behandling |
|---|---|
| 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) | |
| 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) |
Urvalskriterier
| Åldrar berättigade till studier | 6 Months Till 6 Months |
| Kön som är berättigade till studier | All |
| Accepterar friska volontärer | Ja |
| Kriterier | 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 |
Resultat
Primära resultatåtgärder
1. Interest of copeptin dosage as a severity marker in children under the age of 16 with diabatic ketoacidosis [36 hours]
Sekundära resultatåtgärder
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 [36 hours]
