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Midodrine for the Treatment of Refractory Hypotension

This study is currently recruiting participants.
See Contacts and Locations
Verified February 2017 by Matthias Eikermann, Massachusetts General Hospital
Sponsor:
Collaborator:
Sir Charles Gairdner Hospital
Information provided by (Responsible Party):
Matthias Eikermann, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01531959
First received: February 9, 2012
Last updated: February 23, 2017
Last verified: February 2017
  Purpose
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 Intervention Phase
Hypotension Critical Illness Drug: Midodrine Drug: Placebo Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Matthias Eikermann, Massachusetts General Hospital:

Primary Outcome Measures:
  • 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:
  • 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

  • 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

  • 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

  • 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).


Estimated Enrollment: 120
Study Start Date: April 2012
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01531959

Contacts
Contact: Matthias Eikermann, MD, PhD MEIKERMANN@PARTNERS.ORG
Contact: Khushi Chhangani, BSc kchhangani@partners.org

Locations
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Khushi Chhangani, BSc       kchhangani@partners.org   
Principal Investigator: Matthias Eikermann, MD, PhD         
Australia, Western Australia
Sir Charles Gairdner Hospital Recruiting
Nedlands, Western Australia, Australia, 60009
Contact: Matthew Anstey, MBBS, MPH, FACEM, FCICM    +61893461010    matthew.anstey@health.wa.gov.au   
Principal Investigator: Matthew Anstey, MBBS, MPH, FACEM, FCICM         
Sponsors and Collaborators
Massachusetts General Hospital
Sir Charles Gairdner Hospital
Investigators
Principal Investigator: Matthias Eikermann, MD, PhD MGH
  More Information

Responsible Party: Matthias Eikermann, Clinical Director, Critical Care Division, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01531959     History of Changes
Other Study ID Numbers: 2011P002049
2015-098 ( Other Identifier: Sir Charles Gairdner Hospital HREC )
Study First Received: February 9, 2012
Last Updated: February 23, 2017

Keywords provided by Matthias Eikermann, Massachusetts General Hospital:
Midodrine
Hypotension
Intensive care unit
IV vasopressors
ICU discharge

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on September 19, 2017