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
About this trial
This is an interventional treatment trial for Use of Midodrine in Post-cardiopulmonary Bypass Vasoplegic Syndrome
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
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
NCT ID
NCT04668859
First Posted
December 9, 2020
Last Updated
June 28, 2022
Sponsor
Medstar Health Research Institute
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
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Midodrine as Novel Treatment of Post-Cardiopulmonary Bypass Vasoplegic Syndrome
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