Effects of Fludrocortisone on Norepinephrine-mean Arterial Pressure Dose-response, Gastric Mucosal Perfusion and Arterial Stiffness in Septic Shock
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Norepinephrine-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 alone on norepinephrine-mean arterial pressure dose-response relationship, gastric mucosal perfusion and arterial stiffness in patients with septic shock.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients over than 18 years old
- •Septic shock
- •Haemodynamic stability (mean arterial pressure between 70 and 80 mmHg) for at least 1 hour, with a norepinephrine dose less than 0,5 µg/kg/min
- •Written informed consent
排除标准
- •Corticotherapy
- •Known allergy to Fludrocortisone
- •Esophageal or gastric disease
- •Pregnant woman
- •Inclusion in another clinical trial
研究组 & 干预措施
1
Fludrocortisone
干预措施: Fludrocortisone (Drug)
2
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Norepinephrine-mean arterial pressure dose-response relationship
时间窗: 1.5 h after administration
次要结局
- Plasma electrolytes, blood glucose, serum creatinine(Each hour during 3 h after administration)
- Humeral diameter and distensibility(During 3 h after administration)
- Central aortic pressures, Augmentation Index (Aix).(During 3 h after administration)
- Plasma renin, aldosterone, norepinephrine, epinephrine, fludrocortisone, TNF alpha concentrations(Each hour during 3 h after administration)
- Urinary electrolytes excretion(Each hour during 3 h after administration)
- Arterial stiffness: Carotid-femoral Pulse Wave Velocity(During 3 h after administration)
- Systolic and diastolic arterial pressures, heart rate, cardiac output, systemic vascular resistances(During 3 h after administration)
- Gastric mucosal perfusion(During 3 h after administration)