Midodrine for the Treatment of Refractory Hypotension
- Registration Number
- NCT01531959
- Lead Sponsor
- Massachusetts General Hospital
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 139
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo - Midodrine Midodrine -
- Primary Outcome Measures
Name Time Method Time Until Discontinuation of IV Vasopressors 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
- Secondary Outcome Measures
Name Time Method Hospital Length of Stay From initiation of midodrine until hospital discharge, assessed up to 90 days Measured number of days from initiation of midodrine until discharged from hospital
Rates of ICU Readmission Up to 2 months after ICU discharge Number of patients initiated on midodrine that are readmitted back to ICU after being discharged to floor
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. Measured rates of hypertension (increase in systolic blood pressure to values higher than those set by the primary team or greater than 160 mmg), bradycardia (decrease in heart rate to values lower than those set by the primary team or less than 40 BPM), hemodynamically significant tachyarrythmias (greater than 20 mmhg decrease in systolic blood pressure).
ICU Length of Stay From initiation of midodrine until ICU discharge, assessed up to 45 days Measured number of days from initiation of midodrine until discharge ready from the ICU
Trial Locations
- Locations (3)
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Sir Charles Gairdner Hospital
🇦🇺Nedlands, Western Australia, Australia
Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States