Midodrine for the Treatment of Refractory Hypotension

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 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: December 5, 2013
Last verified: December 2013

February 9, 2012
December 5, 2013
April 2012
August 2015   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01531959 on ClinicalTrials.gov Archive Site
  • 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).
Same as current
Not Provided
Not Provided
 
Midodrine for the Treatment of Refractory Hypotension
Midodrine for the Treatment of Refractory Hypotension in Patients Otherwise Ready for Discharge From the ICU

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Hypotension
  • Critical Illness
  • Drug: Midodrine
    Patients will be randomized to blinded to 20 mg of midodrine
  • Drug: Placebo
    Patients will be randomized to blinded placebo control
  • Active Comparator: Midodrine
    Intervention: Drug: Midodrine
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
120
December 2015
August 2015   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Matthias Eikermann, MD, PhD MEIKERMANN@PARTNERS.ORG
Contact: Alexander Levine, PharmD ARLEVINE@PARTNERS.ORG
United States
 
NCT01531959
2011P002049
No
Matthias Eikermann, Massachusetts General Hospital
Massachusetts General Hospital
Not Provided
Principal Investigator: Matthias Eikermann, MD, PhD MGH
Massachusetts General Hospital
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP