Status:
TERMINATED
Midodrine as Novel Treatment of Post-Cardiopulmonary Bypass Vasoplegic Syndrome
Lead Sponsor:
Medstar Health Research Institute
Conditions:
Use of Midodrine in Post-cardiopulmonary Bypass Vasoplegic Syndrome
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 29 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 8 2018
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT04668859
Start Date
July 29 2016
End Date
August 8 2018
Last Update
July 1 2022
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