Midodrine for the Treatment of Refractory Hypotension

Critical Illness Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01531959
• Other study ID #: 2011P002049
• Secondary ID: 2015-0982018P000
• Status: Completed
• Phase: Phase 3
• Start date: April 2012
• Est. completion date: June 2019

Study information

• Verified date: October 2020
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 139
• Est. completion date: June 2019
• Est. primary completion date: June 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Critical Illness
• Hypotension

Intervention

Drug:
• Midodrine
Patients will be randomized to blinded to 20 mg of midodrine
• Placebo
Patients will be randomized to blinded placebo control

Locations

Country	Name	City	State
Australia	Sir Charles Gairdner Hospital	Nedlands	Western Australia
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	Sir Charles Gairdner Hospital

Countries where clinical trial is conducted

United States,  Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time Until Discontinuation of IV Vasopressors	Measured hours from initiation of midodrine until discontinuation of IV vasopressors	From initiation of the study drug until discontinuation of IV vasopressors, assessed up to 400 hours
Secondary	ICU Length of Stay	Measured number of days from initiation of midodrine until discharge ready from the ICU	From initiation of midodrine until ICU discharge, assessed up to 45 days
Secondary	Hospital Length of Stay	Measured number of days from initiation of midodrine until discharged from hospital	From initiation of midodrine until hospital discharge, assessed up to 90 days
Secondary	Rates of ICU Readmission	Number of patients initiated on midodrine that are readmitted back to ICU after being discharged to floor	Up to 2 months after ICU discharge
Secondary	Rates of Hypertension, Bradycardia, and Hemodynamically Significant Tacharrythmias	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).	From initiation of the study drug until discontinuation of the study drug, an average of 59 hours.