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Midodrine for the Treatment of Refractory Hypotension

This study is currently recruiting participants.
Verified May 2013 by Massachusetts General Hospital
Sponsor:
Information provided by (Responsible Party):
Matthias Eikermann, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01531959
First received: February 9, 2012
Last updated: May 7, 2013
Last verified: May 2013
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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:

U.S. FDA Resources

Further study details as provided by 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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 2014
Estimated Primary Completion Date: August 2014 (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
Genders Eligible for Study:   Both
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 and unable to wean for more than 24 hours while still maintaining desired blood pressure goal

Exclusion Criteria:

  • Inadequate tissue oxygenation (lactate > 1 mmol plus any acute rise in SCr by at least 0.5 mg/dl within 24 hours, BUN, troponin, bilirubin, LFTs)
  • Liver failure (bilirubin > 2 mg/dl, INR > 1.5)
  • Hypovolemic shock or hypotension due to adrenal insufficiency
  • Recent angiotensin-converting enzyme inhibitor or angiotensin II receptor blocker use
  • Midodrine as pre-admission medication
  • Any known allergies to midodrine
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01531959

Contacts
Contact: Matthias Eikermann, MD, PhD MEIKERMANN@PARTNERS.ORG
Contact: Alexander Levine, PharmD ARLEVINE@PARTNERS.ORG

Locations
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Alex R Levine, PharmD         alevine@partners.org    
Principal Investigator: Matthias Eikermann, MD, PhD            
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: Matthias Eikermann, MD, PhD MGH
  More Information

No publications provided

Responsible Party: Matthias Eikermann, Director of Research, Critical Care Division, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01531959     History of Changes
Other Study ID Numbers: 2011P002049
Study First Received: February 9, 2012
Last Updated: May 7, 2013
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Critical Illness
Hypotension
Disease Attributes
Pathologic Processes
Vascular Diseases
Cardiovascular Diseases
Midodrine
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
 Pharmacologic Actions
Vasoconstrictor Agents
Cardiovascular Agents
Therapeutic Uses
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 May 21, 2013