Fluids Administration During Combined Clonidine-Arginine Growth Hormone Stimulation Test- Randomized, 2 Arms, Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Average blood pressure
研究概览
简要总结
The diagnosis of Growth Hormone deficiency in childhood requires the performance of an artificial pharmacological stimulation tests. There are number of substances that increase the secretion of growth hormone, among them Clonidine and Arginine. One of the possible side effects of both Clonidine and Arginine is a reduction in the blood pressure due to a decreased heart output and declined contraction of peripheral blood vessels. In cases where values of blood pressure at the end of the test are not recovered after two sessions of 15 minutes of physical activity, the patient is treated with I. V of 9%NORMAL SALINE (0. 20cc /Kg) administrated over 30-60 minutes.
The aim of the proposed study is to test whether administration of fluids during the combined Growth Hormone stimulation test Clonidine-Arginine will help in the recovery process from the test (blood pressure > 90/50 mmHg after performing physical activity defined as 15-minutes hike in two consecutive sessions). The study design will be randomized, controlled, 2 arms study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 7 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children referred to combined Arginine- Conidine Growth Hormone stimulation test
- •Girls: 7-14 years old and Boys: 7-16 years old
- •Weight>20 kg
- •Normal thyroid function
排除标准
- •BMI over percentile 85
- •Genetic syndromes or chromosomal disorders
- •Steroid treatment
- •Renal failure
- •Heart failure
结局指标
主要结局
Average blood pressure
时间窗: Time 180 mnutes- at time of discharging the participant
Average blood pressure ( 3 measurements in 5 minutes intervals)
次要结局
- Average blood pressure(Time 150 minutes after completing the Arginine adminstration)
- Time elapsed between completing the Growth Hormone test until participant is allowed to go home(Time 180 minutes-at time of discharging the participant (after measuring blood pressure > 50/90mm/Hg))