NCT01531959

Midodrine for the Treatment of Refractory Hypotension

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 139 (actual)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hypotension
• Critical Illness

Interventions

Type	Name	Description
DRUG	Midodrine	Patients will be randomized to blinded to 20 mg of midodrine
DRUG	Placebo	Patients will be randomized to blinded placebo control

Timeline

• Start date: 2012-04-01
• Primary completion: 2019-06-01
• Completion: 2019-06-01
• First posted: 2012-02-13
• Last updated: 2020-10-28
• Results posted: 2019-09-06

Locations

3 sites across 2 countries: United States, Australia