Clinical Study Evaluating the Efficacy and Safety of Adjunctive Use of Midodrine in Septic Shock Patients
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Mortality rates
研究概览
简要总结
Assessing the safety and efficacy of the adjunctive use of midodrine as a vasopressor in septic shock patients by measuring the difference in the mortality rates between control and intervention groups.
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
- None (Participant, Care Provider)
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
- •Adult aged 18 years or older diagnosed with septic shock.
- •Hypotensive and require IV vasopressor for more than 24 hours.
排除标准
- •Hypovolemic shock.
- •Severe organic heart disease (ejection fraction <30 percent).
- •Bradycardia (HR<50 b/m).
- •Chronic kidney disease (serum creatinine >2mg/dl).
- •Thyrotoxicosis.
- •Pheochromocytoma.
- •Known allergy to midodrine.
- •Unable to administer an oral medication.
研究组 & 干预措施
Control
Will receive IV vasopressor infusion only
干预措施: Midodrine Oral Tablet (Drug)
Midodrine
Will receive oral midodrine 10 mg/ 8 hours in addition to IV vasopressor infusion till the end of treatment (subject remaining vasopressor-free for 24 consecutive hours).
干预措施: Midodrine Oral Tablet (Drug)
结局指标
主要结局
Mortality rates
时间窗: Time Frame: Starting from date of randomization till shock reversal or date of death from any cause, whichever came first,assessed up to 30 days
The primary outcome is measuring the difference in ICU mortality rates between control and intervention group.
次要结局
未报告次要终点
研究者
Noha Mansour
Principal investigator-Lecturer of Clinical Pharmacy-Clinical Pharmacy and Pharmacy Practice Department
Mansoura University