Midodrine for the Treatment of Refractory Hypotension
Primary Purpose
Hypotension, Critical Illness
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Midodrine
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Hypotension focused on measuring Midodrine, Hypotension, Intensive care unit, IV vasopressors, ICU discharge
Eligibility Criteria
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
Sites / Locations
- Massachusetts General Hospital
- Beth Israel Deaconess Medical Center
- Sir Charles Gairdner Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Midodrine
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Time Until Discontinuation of IV Vasopressors
Measured hours from initiation of midodrine until discontinuation of IV vasopressors
Secondary Outcome Measures
ICU Length of Stay
Measured number of days from initiation of midodrine until discharge ready from the ICU
Hospital Length of Stay
Measured number of days from initiation of midodrine until discharged from hospital
Rates of ICU Readmission
Number of patients initiated on midodrine that are readmitted back to ICU after being discharged to floor
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).
Full Information
NCT ID
NCT01531959
First Posted
February 9, 2012
Last Updated
October 5, 2020
Sponsor
Massachusetts General Hospital
Collaborators
Sir Charles Gairdner Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01531959
Brief Title
Midodrine for the Treatment of Refractory Hypotension
Official Title
Midodrine for the Treatment of Refractory Hypotension in Patients Otherwise Ready for Discharge From the ICU
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
April 2012 (undefined)
Primary Completion Date
June 2019 (Actual)
Study Completion Date
June 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
Sir Charles Gairdner Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypotension, Critical Illness
Keywords
Midodrine, Hypotension, Intensive care unit, IV vasopressors, ICU discharge
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
139 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Midodrine
Arm Type
Active Comparator
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Midodrine
Intervention Description
Patients will be randomized to blinded to 20 mg of midodrine
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Patients will be randomized to blinded placebo control
Primary Outcome Measure Information:
Title
Time Until Discontinuation of IV Vasopressors
Description
Measured hours from initiation of midodrine until discontinuation of IV vasopressors
Time Frame
From initiation of the study drug until discontinuation of IV vasopressors, assessed up to 400 hours
Secondary Outcome Measure Information:
Title
ICU Length of Stay
Description
Measured number of days from initiation of midodrine until discharge ready from the ICU
Time Frame
From initiation of midodrine until ICU discharge, assessed up to 45 days
Title
Hospital Length of Stay
Description
Measured number of days from initiation of midodrine until discharged from hospital
Time Frame
From initiation of midodrine until hospital discharge, assessed up to 90 days
Title
Rates of ICU Readmission
Description
Number of patients initiated on midodrine that are readmitted back to ICU after being discharged to floor
Time Frame
Up to 2 months after ICU discharge
Title
Rates of Hypertension, Bradycardia, and Hemodynamically Significant Tacharrythmias
Description
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).
Time Frame
From initiation of the study drug until discontinuation of the study drug, an average of 59 hours.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matthias Eikermann, MD, PhD
Organizational Affiliation
Beth Israel Deaconess Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Sir Charles Gairdner Hospital
City
Nedlands
State/Province
Western Australia
ZIP/Postal Code
60009
Country
Australia
12. IPD Sharing Statement
Citations:
PubMed Identifier
28327122
Citation
Anstey MH, Wibrow B, Thevathasan T, Roberts B, Chhangani K, Ng PY, Levine A, DiBiasio A, Sarge T, Eikermann M. Midodrine as adjunctive support for treatment of refractory hypotension in the intensive care unit: a multicenter, randomized, placebo controlled trial (the MIDAS trial). BMC Anesthesiol. 2017 Mar 21;17(1):47. doi: 10.1186/s12871-017-0339-x.
Results Reference
derived
Learn more about this trial
Midodrine for the Treatment of Refractory Hypotension
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