Midodrine for the Treatment of Refractory Hypotension in Patients Otherwise Ready for Discharge From the ICU
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 139
- 试验地点
- 3
- 主要终点
- Time Until Discontinuation of IV Vasopressors
研究概览
简要总结
We hypothesize that midodrine treatment of refractory hypotension in patients otherwise ready for discharge from the ICU shortens duration of receiving IV vasopressors and SICU length of stay without increasing MGH length of stay or putting the patient at risk of being readmitted to an ICU.
详细描述
Persistent hypotension in critically ill patients remains a major barrier to discharging patients from the intensive care unit (ICU). In our hospital, in patients with adequate tissue perfusion, midodrine has been observed to treat hypotension in order to wean continuous intravenous (IV) vasopressors and therefore promote ICU discharge. There are several possible etiologies of hypotension in the ICU. The most frequently seen causes include septic shock, hypovolemia, adrenal insufficiency, and idiosyncratic reactions from medications. For patients whose reversible causes of hypotension have been addressed but still require vasopressors, midodrine may prove to be a useful adjunctive medication to successfully increase blood pressure. No previous studies have examined the use of midodrine for the treatment of hypotension in an ICU setting. Therefore, we are investigating a new indication for midodrine as the treatment of hypotension in critically ill patients.
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
- •At least 18 years of age
- •Admitted to the SICU
- •Requiring IV vasopressors at a rate of less than 100 mcg/min of phenylephrine, or 8 mcg/min of norepinephrine, or 60 mcg/min of metaraminol; and unable to wean for more than 24 hours while still maintaining desired blood pressure goal
排除标准
- •Inadequate tissue oxygenation
- •Liver failure
- •Renal failure
- •Hypovolemic shock or hypotension due to adrenal insufficiency
- •Pregnancy
- •Severe organic heart disease
- •Urinary retention
- •Pheochromocytoma
- •Thyrotoxicosis
- •Midodrine as pre-admission medication
- •Any known allergies to midodrine
- •Enrollment in another clinical trial
研究组 & 干预措施
Midodrine
干预措施: Midodrine (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Time Until Discontinuation of IV Vasopressors
时间窗: From initiation of the study drug until discontinuation of IV vasopressors, assessed up to 400 hours
Measured hours from initiation of midodrine until discontinuation of IV vasopressors
次要结局
- Hospital Length of Stay(From initiation of midodrine until hospital discharge, assessed up to 90 days)
- Rates of ICU Readmission(Up to 2 months after ICU discharge)
- Rates of Hypertension, Bradycardia, and Hemodynamically Significant Tacharrythmias(From initiation of the study drug until discontinuation of the study drug, an average of 59 hours.)
- ICU Length of Stay(From initiation of midodrine until ICU discharge, assessed up to 45 days)
研究者
Matthias Eikermann, MD PhD
Vice Chair of Faculty Affairs of the Department of Anesthesia Critical Care and Pain Medicine
Beth Israel Deaconess Medical Center