Midodrine for the Treatment of Refractory Hypotension

Mass General Brigham

Status and phase: Completed; Phase 3

Conditions: Hypotension; Critical Illness

Treatments: Drug: Midodrine; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01531959

2015-098 (Other Identifier)

2018P000162 (Other Identifier)

2011P002049

Details and patient eligibility

About

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.

Full 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.

Enrollment: 139 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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139 participants in 2 patient groups, including a placebo group

Midodrine

Active Comparator group

Treatment:

Drug: Midodrine

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo