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Midodrine as Novel Treatment of Post-Cardiopulmonary Bypass Vasoplegic Syndrome

Midodrine as Novel Treatment of Post-Cardiopulmonary Bypass Vasoplegic Syndrome

Status
Terminated
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04668859
Enrollment
10
Registered
2020-12-16
Start date
2016-07-29
Completion date
2018-08-08
Last updated
2022-07-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Use of Midodrine in Post-cardiopulmonary Bypass Vasoplegic Syndrome

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

Interventions

DRUGMidodrine

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.

Placebo will consist of inert methylcellulose

Sponsors

Medstar Health Research Institute
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Time from procedure end until discontinuation of IV vasopressors12 months

Secondary

MeasureTime frame
Rate of decline in IV vasopressor dose12 months
Time until CVL removal12 mothns
ICU length of stay12 months
Hospital length of stay12 months
Rate of major infections/complications12 months
Rate of in-hospital and 30-day mortality12 months

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026