Use of Copeptin in the Differential Diagnosis of Diabetes insipidus-a Prospective International Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 156
- 试验地点
- 1
- 主要终点
- Overall diagnostic accuracy
研究概览
简要总结
Prospective evaluation of the novel biomarker copeptin in the differential diagnosis of diabetes insipidus against the standard diagnostic test methods.
详细描述
Purpose of this study is to compare the overall diagnostic accuracy of the three following diagnostic test procedures in diabetes insipidus (central, nephrogenic) and primary polydipsia: a) classical water deprivation test alone, b) classical water deprivation test plus plasma copeptin cut-off levels, c) hypertonic saline infusion test plus plasma copeptin measurement.
The investigators hypothesize that firstly b) and c) is better as a). Secondly the investigators hypothesize that c) is non-inferior to b).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 16 Years 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Polyuria or/and Polydipsia or/and therapy with synthetic adenovirus proteinase (AVP) derivate
- •Urine osmolality <800mOsm/kgH20
排除标准
- •Polyuria due to diabetes mellitus
- •Hypokalemia
- •Hyperkalemia (>5mmol/l)
- •Hypercalcemia
- •Kidney disease (min.: glomerular filtration rate (GFR) 60ml/min/1.73m2)
- •Pregnancy
- •Hyponatremia >135mmol/L
- •Hypernatremia >145mmol/L
- •Hypo- or hypervolemia
- •uncorrected adrenal or thyroidal deficiency
- •Cardia failure
- •Epilepsia
- •Uncontrolled hypertension
结局指标
主要结局
Overall diagnostic accuracy
时间窗: beginning and end of protocol, up to 9hours
Ratio of the number of correctly diagnosed patients to the number of all tested patients for the tests: * classical water deprivation test alone * classical water deprivation test plus plasma copeptin cut-off levels * hypertonic saline Infusion test plus plasma copeptin measurements
次要结局
- Sensitivity, specificity, positive and negative predictive value(beginning and end of protocol, up to 9hours)
- post-hoc best copeptin cut-off optimising overall performance(beginning and end of protocol, up to 9hours)
- subjective burden as rated by patients on visual analogue scale(beginning, during and end of protocol, up to 9hours)
- Predictive value of specific anamnestic and clinical features(before tests)
- Predictive value of absent bright spot in posterior pituitary enlargement(before or after tests)