Midodrine Use in the Recovery Phase of Septic Shock
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- ICU free days
研究概览
简要总结
The aim of this study is to investigate the role of oral midodrine in the recovery of septic shock. The investigators hypothesize that the oral drug can reduce central line days and ICU length of stay.
详细描述
The investigators aim to investigate the use of midodrine in the recovery phase of septic shock in a randomized control trial. The investigators hypothesize that midodrine use initiated after stabilization or improving intravenous vasopressor requirement will lead to decreased length of ICU stay and length of time that intravenous vasopressors are required.
The investigators plan to enroll and consent patients at the onset of septic shock. Once IV vasopressor requirement is stabilized or decreasing, males and females will be randomized in 1:1 fashion to receive either standard clinical care or standard clinical care plus oral midodrine. The investigators will analyze length of stay in the ICU, time on vasopressors, time needing a central line, and hospital length of stay.
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
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 aged 18-99 years old
- •Admitted to UVA medical ICU with diagnosis of septic shock.
排除标准
- •Pregnant females, patients with childbearing potential will have urine pregnancy testing after consent
- •Patients < 18 years
- •Prisoners
- •Patients already taking midodrine
- •Patients with cirrhosis and Child-Pugh Class C (Child-Pugh score > 9)_
- •Patients with Increased intraocular pressure and glaucoma
- •Patients with allergy to midodrine
- •Non-English speaking patients
- •Patients without enteral access
- •Patients where the attending physician does not feel MAP goal of > 65 mmHg is physiologically acceptable.
研究组 & 干预措施
Intervention
In the intervention arm 10 mg of midodrine will be given orally three times daily starting at the time of stable or decreasing intravenous vasopressor support
干预措施: midodrine (Drug)
Control
The control arm will receive standard of care for septic shock with IV vasopressor support as needed to maintain MAP goal > 65 mmHg
干预措施: Standard of Care (Other)
结局指标
主要结局
ICU free days
时间窗: 28 days
ICU free days from first 28 days
次要结局
- IV vasopressor free days(28 days)
- Hospital length of stay(up to 90 days)
- Central venous catheter free days(28 days)