Midodrine as Novel Treatment of Post-Cardiopulmonary Bypass Vasoplegic Syndrome

NCT ID: NCT04668859

Last Updated: 2022-07-01

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-07-29
• Study Completion Date: 2018-08-08

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

Conditions

Use of Midodrine in Post-cardiopulmonary Bypass Vasoplegic Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Midodrine Arm

Patients will receive the drug Midodrine

Group Type: ACTIVE_COMPARATOR

Midodrine

Intervention Type: DRUG

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 Arm

Patients will receive placebo.

Group Type: PLACEBO_COMPARATOR

Methylcellulose

Intervention Type: DRUG

Placebo will consist of inert methylcellulose

Interventions

Midodrine

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

Methylcellulose

Placebo will consist of inert methylcellulose

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medstar Health Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

2016-097

Identifier Type: -

Identifier Source: org_study_id