Midodrine for the Treatment of Refractory Hypotension
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ClinicalTrials.gov Identifier: NCT01531959 |
Recruitment Status :
Completed
First Posted : February 13, 2012
Results First Posted : October 5, 2020
Last Update Posted : October 28, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Hypotension Critical Illness | Drug: Midodrine Drug: Placebo | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 139 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Midodrine for the Treatment of Refractory Hypotension in Patients Otherwise Ready for Discharge From the ICU |
Study Start Date : | April 2012 |
Actual Primary Completion Date : | June 2019 |
Actual Study Completion Date : | June 2019 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Midodrine |
Drug: Midodrine
Patients will be randomized to blinded to 20 mg of midodrine |
Placebo Comparator: Placebo |
Drug: Placebo
Patients will be randomized to blinded placebo control |
- 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
- 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
- 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
- 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
- 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).

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01531959
United States, Massachusetts | |
Massachusetts General Hospital | |
Boston, Massachusetts, United States, 02114 | |
Beth Israel Deaconess Medical Center | |
Boston, Massachusetts, United States, 02215 | |
Australia, Western Australia | |
Sir Charles Gairdner Hospital | |
Nedlands, Western Australia, Australia, 60009 |
Principal Investigator: | Matthias Eikermann, MD, PhD | Beth Israel Deaconess Medical Center |
Documents provided by Matthias Eikermann, MD PhD, Beth Israel Deaconess Medical Center:
Responsible Party: | Matthias Eikermann, MD PhD, Vice Chair of Faculty Affairs of the Department of Anesthesia Critical Care and Pain Medicine, Beth Israel Deaconess Medical Center |
ClinicalTrials.gov Identifier: | NCT01531959 |
Other Study ID Numbers: |
2011P002049 2015-098 ( Other Identifier: Sir Charles Gairdner Hospital HREC ) 2018P000162 ( Other Identifier: Beth Israel Deaconess Medical Center ) |
First Posted: | February 13, 2012 Key Record Dates |
Results First Posted: | October 5, 2020 |
Last Update Posted: | October 28, 2020 |
Last Verified: | October 2020 |
Midodrine Hypotension Intensive care unit IV vasopressors ICU discharge |
Hypotension Critical Illness Vascular Diseases Cardiovascular Diseases Disease Attributes Pathologic Processes Midodrine Sympathomimetics Autonomic Agents |
Peripheral Nervous System Agents Physiological Effects of Drugs Vasoconstrictor Agents Adrenergic alpha-1 Receptor Agonists Adrenergic alpha-Agonists Adrenergic Agonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |