Midodrine for the Treatment of Refractory Hypotension

Last updated: October 5, 2020
Sponsor: Massachusetts General Hospital
Overall Status: Completed

Phase

3

Condition

Vascular Diseases

Dizzy/fainting Spells

Circulation Disorders

Treatment

N/A

Clinical Study ID

NCT01531959
2011P002049
2018P000162
2015-098
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 8mcg/min of norepinephrine, or 60 mcg/min of metaraminol; and unable to wean for morethan 24 hours while still maintaining desired blood pressure goal

Exclusion

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

Study Design

Total Participants: 139
Study Start date:
April 01, 2012
Estimated Completion Date:
June 30, 2019

Study 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.

Connect with a study center

  • Sir Charles Gairdner Hospital

    Nedlands, Western Australia 60009
    Australia

    Site Not Available

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts 02215
    United States

    Site Not Available

  • Massachusetts General Hospital

    Boston, Massachusetts 02114
    United States

    Site Not Available

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