Impact of Midodrine Administration on the Clinical Outcome of Septic Shock Patients
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Time of weaning of IV vasopressor in both groups
研究概览
简要总结
- Assess the impact of midodrine administration on weaning of IV vasopressors
- Assess the cost effectiveness of using midodrine in critically ill patients
详细描述
A prospective randomized controlled clinical trial on total 60 critically ill patients admitted to critical care medicine department with indication to IV vasopressor due to septic shock on admission or during intensive care unit stay and they are randomly assigned to either of 2 groups as follows
- Group 1(n=30):will receive IV vasopressor infusion only
- Group 2(n=30):will receive midodrine in addition to IV vasopressor infusion
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients (18-80)years
- •Hypotensive (systolic blood pressure<90mm Hg)and require IV vasopressor for more than 24 hours
- •Require IV vasopressor at rate < 8mcg/min and unable to wean for >24 hours
排除标准
- •Severe organic heart disease (ejection fraction <30 percent due to higher risk of arrythmia)
- •Bradycardia (HR<50 b/m)due to higher likelihood of symptomatic bradycardia
- •Chronic kidney disease (serum creatinine >2mg/dl) as midodrine and its active metabolites are almost completely execreated in urine
- •Thyrotoxicosis
- •Known allergy to midodrine
研究组 & 干预措施
Midodrine
Will receive midodrine in addition to IV vasopressor infusion
干预措施: Midodrine (Drug)
结局指标
主要结局
Time of weaning of IV vasopressor in both groups
时间窗: Starting from date of randomization till stop of IV vasopressor completely or date of death from any cause,whichever came first,assessed up to 30 days
measure duration needed to completely stop IV vasopressor in both groups and the impact of adding midodrine on that duration
次要结局
- ICU length of stay(Starting from date of randomization until ICU discharge or date of death from any cause,whichever came first,assessed up to 30 days)
- Time to ICU discharge after midodrine initiation(Starting from midodrine initiation until ICU discharge or date of death from any cause,whichever came first,assessed up to 30 days)
- Mortality(Up to 30 days)
- Time to ICU discharge after IV vasopressor discontinuation(Starting from discontinuation of IV vasopressor until time to ICU discharge or date of death from any cause ,whichever came first,assessed up to 30 days)
研究者
Dina hussein ahmed eladly
clinical pharmacist
Ain Shams University