Clinical trial NCT04668859: 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
Overall status: TERMINATED
Phase: PHASE4
Conditions: Use of Midodrine in Post-cardiopulmonary Bypass Vasoplegic Syndrome
Lead sponsor: Medstar Health Research Institute
Sponsor class: OTHER
First posted: 2020-12-16
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Time from procedure end until discontinuation of IV vasopressors
timeFrame: 12 months
Secondary outcomes:
measure: Rate of decline in IV vasopressor dose
timeFrame: 12 months
measure: Time until CVL removal
timeFrame: 12 mothns
measure: ICU length of stay
timeFrame: 12 months
measure: Hospital length of stay
timeFrame: 12 months
measure: Rate of major infections/complications
timeFrame: 12 months
measure: Rate of in-hospital and 30-day mortality
timeFrame: 12 months
Other outcomes:
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