A Phase 4 interventional study of Midodrine and Methylcellulose in Use of Midodrine in Post-cardiopulmonary Bypass Vasoplegic Syndrome, sponsored by Medstar Health Research Institute. Terminated. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-07-01.
Sponsored by Medstar Health Research Institute · Phase 4, Interventional, and Treatment
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
48 studies on the registry are indexed under Vasoplegia; 19 are open to participants now.
This study's enrollment of 10 is below the median of 110 across 27 interventional studies indexed under Vasoplegia.
Browse Vasoplegia studies →Medstar Health Research Institute is the lead sponsor of 161 studies on the registry; 31 are open to participants now.
Of its 14 completed or terminated interventional studies of FDA-regulated products, 7 (50%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
vasoplegic syndrome criteria
vasopressor requirement
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients will receive the drug Midodrine
Drug: Midodrine
Patients will receive placebo.
Drug: Methylcellulose
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
Time from procedure end until discontinuation of IV vasopressors
Time frame: 12 months
Rate of decline in IV vasopressor dose
Time frame: 12 months
Time until CVL removal
Time frame: 12 mothns
ICU length of stay
Time frame: 12 months
Hospital length of stay
Time frame: 12 months
Rate of major infections/complications
Time frame: 12 months
Rate of in-hospital and 30-day mortality
Time frame: 12 months
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
Ran from Jul 2016 to primary completion in Aug 2018, 24 months.
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This study is terminated, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Midodrine
Medstar Health Research Institute →