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临床试验/NCT02994316
NCT02994316已完成不适用

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

University Hospital, Montpellier2 个研究点 分布在 1 个国家目标入组 58 人开始时间: 2016年10月3日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
58
试验地点
2
主要终点
Interest of copeptin dosage as a severity marker in children under the age of 16 with diabatic ketoacidosis

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
6 Months 至 16 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

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

时间窗: 36 hours

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

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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