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Midodrine as Novel Treatment of Post-Cardiopulmonary Bypass Vasoplegic Syndrome

Primary Purpose

Use of Midodrine in Post-cardiopulmonary Bypass Vasoplegic Syndrome

Status
Terminated
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Midodrine
Methylcellulose
Sponsored by
Medstar Health Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Use of Midodrine in Post-cardiopulmonary Bypass Vasoplegic Syndrome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • post-cardiopulmonary bypass surgery
  • vasoplegic syndrome criteria

    1. MAP < 65mmHg
    2. Cardiac index>/=2.4 L/min/m^2, as determined by Swan-
    3. systemic vascular resistance index </=1400 dynes s/cm^5/m^2
    4. adequate fluid resuscitation as determined by treating critical care team
  • vasopressor requirement

    1. norepinephrine 0.05-0.5 mcg/kg/min WITH/WITHOUT
    2. vasopressin any dose

Exclusion Criteria:

  • allergy to midodrine
  • pregnancy
  • midodrine or cardiac glycoside as preadmission medication
  • history of orthostatic hypotension, thyrotoxicosis, or pheochromocytoma
  • severe organic heart disease (endocarditis, untreated congenital or rheumatic heart disease)
  • liver failure/cirrhosis
  • chronic kidney disease (GFR <30mL/hr)
  • ventricular assist device implantation procedure, intra-aortic balloon pump placement, or heart transplantion
  • unresolved post-operative acute kidney injury (rise in serum creatinine by >/= 0.5mg/dl from baseline
  • inadequate tissue oxygenation (lactate > 2 mmol/L)
  • inability to take oral medications

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Placebo Comparator

    Arm Label

    Midodrine Arm

    Placebo Arm

    Arm Description

    Patients will receive the drug Midodrine

    Patients will receive placebo.

    Outcomes

    Primary Outcome Measures

    Time from procedure end until discontinuation of IV vasopressors

    Secondary Outcome Measures

    Rate of decline in IV vasopressor dose
    Time until CVL removal
    ICU length of stay
    Hospital length of stay
    Rate of major infections/complications
    Rate of in-hospital and 30-day mortality

    Full Information

    First Posted
    December 9, 2020
    Last Updated
    June 28, 2022
    Sponsor
    Medstar Health Research Institute
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04668859
    Brief Title
    Midodrine as Novel Treatment of Post-Cardiopulmonary Bypass Vasoplegic Syndrome
    Official Title
    Midodrine as Novel Treatment of Post-Cardiopulmonary Bypass Vasoplegic Syndrome
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2022
    Overall Recruitment Status
    Terminated
    Why Stopped
    PI relocated
    Study Start Date
    July 29, 2016 (Actual)
    Primary Completion Date
    August 8, 2018 (Actual)
    Study Completion Date
    August 8, 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Medstar Health Research Institute

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    Yes
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Vasoplegic syndrome (VS) is a common and serious complication of cardiopulmonary bypass (CPB) procedures associated with a significant increase in morbidity and mortality. VS is defined as significant hypotension, high or normal cardiac outputs, low systemic vascular resistance, low cardiac filling pressures, and vasopressor requirement despite adequate fluid resuscitation following CPB. Extensive research has been performed regarding the pathophysiologic response to CPB and risk factors associated with VS. No safe and effective preventive strategy has gained widespread use. Supportive care with intravenous (IV) vasopressors has thus been adopted as standard of care. The use of these medications, while effective in the majority of patients, generally necessitates close monitoring in an intensive care unit (ICU) setting. These patients are subject to prolonged ICU and hospital stays, as well as the potential complications of prolonged use of central venous lines (CVL) required to give these medications. Recent studies suggest midodrine, a generic oral vasopressor, may accelerate the decline in IV vasopressor requirements in select ICU patients. At our institution, the addition of midodrine to IV vasopressors for the treatment of VS has been observed to be effective in reducing IV vasopressor duration. No literature exists describing the use of midodrine in this patient population. The goal of this study is to investigate the novel use of midodrine in CPB surgery complicated by VS. Ultimately, we hope to produce literature supporting its use that may be applied on a global scale to improve patient care

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Use of Midodrine in Post-cardiopulmonary Bypass Vasoplegic Syndrome

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    10 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Midodrine Arm
    Arm Type
    Active Comparator
    Arm Description
    Patients will receive the drug Midodrine
    Arm Title
    Placebo Arm
    Arm Type
    Placebo Comparator
    Arm Description
    Patients will receive placebo.
    Intervention Type
    Drug
    Intervention Name(s)
    Midodrine
    Intervention Description
    Oral vasoactive that is metabolized by the liver an peripheral tissues into desglymidodrine, an active metabolite. It produces arteriolar and venous constriction with a subsequent elevation in blood pressure.
    Intervention Type
    Drug
    Intervention Name(s)
    Methylcellulose
    Intervention Description
    Placebo will consist of inert methylcellulose
    Primary Outcome Measure Information:
    Title
    Time from procedure end until discontinuation of IV vasopressors
    Time Frame
    12 months
    Secondary Outcome Measure Information:
    Title
    Rate of decline in IV vasopressor dose
    Time Frame
    12 months
    Title
    Time until CVL removal
    Time Frame
    12 mothns
    Title
    ICU length of stay
    Time Frame
    12 months
    Title
    Hospital length of stay
    Time Frame
    12 months
    Title
    Rate of major infections/complications
    Time Frame
    12 months
    Title
    Rate of in-hospital and 30-day mortality
    Time Frame
    12 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: post-cardiopulmonary bypass surgery vasoplegic syndrome criteria MAP < 65mmHg Cardiac index>/=2.4 L/min/m^2, as determined by Swan- systemic vascular resistance index </=1400 dynes s/cm^5/m^2 adequate fluid resuscitation as determined by treating critical care team vasopressor requirement norepinephrine 0.05-0.5 mcg/kg/min WITH/WITHOUT vasopressin any dose Exclusion Criteria: allergy to midodrine pregnancy midodrine or cardiac glycoside as preadmission medication history of orthostatic hypotension, thyrotoxicosis, or pheochromocytoma severe organic heart disease (endocarditis, untreated congenital or rheumatic heart disease) liver failure/cirrhosis chronic kidney disease (GFR <30mL/hr) ventricular assist device implantation procedure, intra-aortic balloon pump placement, or heart transplantion unresolved post-operative acute kidney injury (rise in serum creatinine by >/= 0.5mg/dl from baseline inadequate tissue oxygenation (lactate > 2 mmol/L) inability to take oral medications

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Midodrine as Novel Treatment of Post-Cardiopulmonary Bypass Vasoplegic Syndrome

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