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Midodrine for the Treatment of Refractory Hypotension

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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

Tracking Information
First Submitted Date  ICMJE February 9, 2012
First Posted Date  ICMJE February 13, 2012
Last Update Posted Date September 6, 2019
Study Start Date  ICMJE April 2012
Actual Primary Completion Date June 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 10, 2012)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 10, 2012)
  • 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).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Midodrine for the Treatment of Refractory Hypotension
Official Title  ICMJE Midodrine for the Treatment of Refractory Hypotension in Patients Otherwise Ready for Discharge From the ICU
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Hypotension
  • Critical Illness
Intervention  ICMJE
  • Drug: Midodrine
    Patients will be randomized to blinded to 20 mg of midodrine
  • Drug: Placebo
    Patients will be randomized to blinded placebo control
Study Arms  ICMJE
  • Active Comparator: Midodrine
    Intervention: Drug: Midodrine
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Publications * Anstey MH, Wibrow B, Thevathasan T, Roberts B, Chhangani K, Ng PY, Levine A, DiBiasio A, Sarge T, Eikermann M. Midodrine as adjunctive support for treatment of refractory hypotension in the intensive care unit: a multicenter, randomized, placebo controlled trial (the MIDAS trial). BMC Anesthesiol. 2017 Mar 21;17(1):47. doi: 10.1186/s12871-017-0339-x.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 4, 2019)
139
Original Estimated Enrollment  ICMJE
 (submitted: February 10, 2012)
120
Actual Study Completion Date  ICMJE June 2019
Actual Primary Completion Date June 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01531959
Other Study ID Numbers  ICMJE 2011P002049
2015-098 ( Other Identifier: Sir Charles Gairdner Hospital HREC )
2018P000162 ( Other Identifier: Beth Israel Deaconess Medical Center )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Matthias Eikermann, MD PhD, Beth Israel Deaconess Medical Center
Study Sponsor  ICMJE Massachusetts General Hospital
Collaborators  ICMJE Sir Charles Gairdner Hospital
Investigators  ICMJE
Principal Investigator: Matthias Eikermann, MD, PhD Beth Israel Deaconess Medical Center
PRS Account Massachusetts General Hospital
Verification Date September 2019

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