NCT04668859

Midodrine as Novel Treatment of Post-Cardiopulmonary Bypass Vasoplegic Syndrome

Terminated Phase 4 Last updated 1 July 2022

What this trial tests

Phase 4 trial testing Midodrine in Use of Midodrine in Post-cardiopulmonary Bypass Vasoplegic Syndrome in 10 participants. Terminated before completion.

Timeline

29 July 2016

Primary endpoint
8 August 2018

8 August 2018

Quick facts

Lead sponsor	Medstar Health Research Institute
Phase	Phase 4
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	10
Start date	29 July 2016
Primary completion	8 August 2018
Estimated completion	8 August 2018

Drugs / interventions tested

• Midodrine — full drug profile →
• Methylcellulose — full drug profile →

Conditions studied

• Use of Midodrine in Post-cardiopulmonary Bypass Vasoplegic Syndrome — all drugs for Use of Midodrine in Post-cardiopulmonary Bypass Vasoplegic Syndrome →

Sponsor

Medstar Health Research Institute

Who can join

18 and older, any sex, with Use of Midodrine in Post-cardiopulmonary Bypass Vasoplegic Syndrome. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

No peer-reviewed publications indexed yet for this trial.