Hemodynamic and Biological Effects of Fludrocortisone and Hydrocortisone, in Healthy Volunteers With Aldosterone Induced Suppression
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Phenylephrine-mean arterial pressure dose-response relationship
研究概览
简要总结
Septic shock (associated with relative adrenal insufficiency) is characterized by decreased arterial responsiveness to catecholamines. The association of hydrocortisone and fludrocortisone has demonstrated an improvement in survival in septic shock patients. If hydrocortisone has shown to increase vascular responsiveness, the role of fludrocortisone remains to be elucidated. The purpose of our study is to investigate the effect of a physiological dose of fludrocortisone and/or hydrocortisone on phenylephrine-mean arterial pressure dose-response relationship in healthy volunteers with aldosterone suppression induced by intravenous sodium loading.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 30 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Men between 20 and 30 years
- •Body Mass Index between 18 kg/m² and 25 kg/m²
- •Normal clinical examination
- •Normal biological variables
- •Normal electrocardiogram and echocardiography
- •Written, voluntary informed consent
- •Non smoker since at least a year
- •Non-inclusion Criteria:
- •Any history of significant allergy
- •Subjects with abnormal renal, pulmonary, cardiovascular, endocrine or hepatic function
- •Medication during the study
- •Alcohol consumption more than 30g/day or drug addiction
- •Positive serology for hepatitis B virus (HBV), hepatitis C virus (HCV) or HIV.
- •Exclusion period mentioned on the Healthy Volunteers National list
- •Persons deprived of freedom or under guardianship
排除标准
- 未提供
研究组 & 干预措施
1
Fludrocortisone and Hydrocortisone
干预措施: Fludrocortisone (Drug)
1
Fludrocortisone and Hydrocortisone
干预措施: Hydrocortisone (Drug)
2
Fludrocortisone and placebo of Hydrocortisone
干预措施: Fludrocortisone (Drug)
2
Fludrocortisone and placebo of Hydrocortisone
干预措施: Placebo of Hydrocortisone (Drug)
3
Placebo of Fludrocortisone and Hydrocortisone
干预措施: Hydrocortisone (Drug)
3
Placebo of Fludrocortisone and Hydrocortisone
干预措施: Placebo of Fludrocortisone (Drug)
4
Placebo of Fludrocortisone and placebo of Hydrocortisone
干预措施: Placebo of Fludrocortisone (Drug)
4
Placebo of Fludrocortisone and placebo of Hydrocortisone
干预措施: Placebo of Hydrocortisone (Drug)
结局指标
主要结局
Phenylephrine-mean arterial pressure dose-response relationship
时间窗: Between 1.5 and 3 hours after treatment
次要结局
- Systolic and diastolic arterial pressures, heart rate, cardiac output, systemic vascular resistances(Between administration time and 24 hours after treatment)
- Humeral diameter and distensibility(Between administration time and 12 hours after treatment)
- Plasma electrolytes, blood glucose, serum creatinine(Between administration time and 24 hours after treatment)
- Plasma renin, aldosterone, norepinephrine, epinephrine, hydrocortisone, fludrocortisone concentrations(Between administration time and 24 hours after treatment)
- Central aortic pressures, Augmentation Index (Aix)(Between administration time and 12 hours after treatment)
- Arterial stiffness: Carotid-femoral Pulse Wave Velocity(Between administration time and 12 hours after treatment)
- Urinary electrolytes excretion(Between administration time and 24 hours after treatment)