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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Midodrine Arm | Active Comparator | Patients will receive the drug Midodrine |
|
| Placebo Arm | Placebo Comparator | Patients will receive placebo. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Midodrine | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Time from procedure end until discontinuation of IV vasopressors | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of decline in IV vasopressor dose | 12 months | |
| Time until CVL removal | 12 mothns | |
| ICU length of stay |
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Inclusion Criteria:
post-cardiopulmonary bypass surgery
vasoplegic syndrome criteria
vasopressor requirement
Exclusion Criteria:
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jan 19, 2023 | |
| Reset | Feb 15, 2023 | |
| Release | Jun 6, 2024 | |
| Reset | Jul 1, 2024 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jan 19, 2023 | Feb 15, 2023 | |||
| Jun 6, 2024 |
| ID | Term |
|---|---|
| D008879 | Midodrine |
| D008747 | Methylcellulose |
| ID | Term |
|---|---|
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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| Methylcellulose | Drug | Placebo will consist of inert methylcellulose |
|
| 12 months |
| Hospital length of stay | 12 months |
| Rate of major infections/complications | 12 months |
| Rate of in-hospital and 30-day mortality | 12 months |
| Jul 1, 2024 |
| D000588 |
| Amines |
| D002482 | Cellulose |
| D005936 | Glucans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |