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Midodrine for the Treatment of Refractory Hypotension

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01531959
Recruitment Status : Completed
First Posted : February 13, 2012
Last Update Posted : September 6, 2019
Sponsor:
Collaborator:
Sir Charles Gairdner Hospital
Information provided by (Responsible Party):
Matthias Eikermann, MD PhD, Beth Israel Deaconess Medical Center

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.

Condition or disease Intervention/treatment Phase
Hypotension Critical Illness Drug: Midodrine Drug: Placebo Phase 3

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.

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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

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Time until discontinuation of IV vasopressors [ Time Frame: IV vasopressors expected to be discontinued 1 day to 7 days after starting midodrine ]
    Measured hours from initiation of midodrine until discontinuation of IV vasopressors


Secondary Outcome Measures :
  1. ICU length of stay [ Time Frame: Patients are expected to be discharged from the SICU 5 to 7 days after starting midodrine ]
    Measured number of days from initiation of midodrine until discharge ready from the ICU

  2. Hospital length of stay [ Time Frame: Patients are expected to be discharged from the hospital 2 to 4 weeks after starting midodrine ]
    Measured number of days from initiation of midodrine until discharged from hospital

  3. Rates of ICU readmission [ Time Frame: Expected that patients will be followed 1 to 2 weeks after discharge to assess rates of readmission ]
    Number of patients initiated on midodrine that are readmitted back to ICU after being discharged to floor

  4. Rates of hypertension, bradycardia, and hemodynamically significant tacharrythmias [ Time Frame: Rates of side effects will be followed while patient is on midodrine which is expected to be 5 to 7 days ]
    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
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

Information from the National Library of Medicine

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


Locations
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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
Sponsors and Collaborators
Massachusetts General Hospital
Sir Charles Gairdner Hospital
Investigators
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Principal Investigator: Matthias Eikermann, MD, PhD Beth Israel Deaconess Medical Center

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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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
Last Update Posted: September 6, 2019
Last Verified: September 2019
Keywords provided by Matthias Eikermann, MD PhD, Beth Israel Deaconess Medical Center:
Midodrine
Hypotension
Intensive care unit
IV vasopressors
ICU discharge
Additional relevant MeSH terms:
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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