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Completed

NCT Number: NCT01531959

Midodrine for the Treatment of Refractory Hypotension

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Sir Charles Gairdner Hospital, Nedlands, Western Australia, Australia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Midodrine

Drug

Patients will be randomized to blinded to 20 mg of midodrine

Placebo

Drug

Patients will be randomized to blinded placebo control

Primary outcomes

  1. Time Until Discontinuation of IV Vasopressors

    Time frame: 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 outcomes

  1. ICU Length of Stay

    Time frame: 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

  2. Hospital Length of Stay

    Time frame: From initiation of midodrine until hospital discharge, assessed up to 90 days

    Measured number of days from initiation of midodrine until discharged from hospital

  3. Rates of ICU Readmission

    Time frame: Up to 2 months after ICU discharge

    Number of patients initiated on midodrine that are readmitted back to ICU after being discharged to floor

  4. Rates of Hypertension, Bradycardia, and Hemodynamically Significant Tacharrythmias

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • Sir Charles Gairdner Hospital

Registry information

Official study title

Midodrine for the Treatment of Refractory Hypotension in Patients Otherwise Ready for Discharge From the ICU

Important dates

Study start
2012
Primary completion
2019
Study completion
2019
First posted
Feb 13, 2012
Registry last updated
Oct 28, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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