Midodrine
DrugPatients will be randomized to blinded to 20 mg of midodrine
NCT Number: NCT01531959
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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Notify Me18 year and older
All sexes
Interventional
Phase 3
Sir Charles Gairdner Hospital, Nedlands, Western Australia, Australia
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Patients will be randomized to blinded to 20 mg of midodrine
Patients will be randomized to blinded placebo control
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
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
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
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
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).
Massachusetts General Hospital
Other
Midodrine for the Treatment of Refractory Hypotension in Patients Otherwise Ready for Discharge From the ICU
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