Last updated on February 2020

SodiUm SeleniTe Adminstration IN Cardiac Surgery (SUSTAIN CSX -Trial).

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Cardiovascular Disease | Heart disease | Cardiac Disease
  • Age: Between 18 - 100 Years
  • Gender: Male or Female

Inclusion Criteria:

  • Adult patients (>/=18 years of age)
  • Scheduled to undergo elective or urgent cardiac surgery with the use of cardiopulmonary bypass (CPB) and cardioplegic arrest that exhibit a high perioperative risk profile as defined by the presence of one or more of the following:
  • a) Planned valve surgery combined with CABG or multiple valve replacement/repair surgeries or combined cardiac surgical procedures involving the thoracic aorta; OR
  • b) Any cardiac surgery with a high perioperative risk profile, defined as a predicted operative mortality of 5% (EuroSCORE II).

Exclusion Criteria:

We will exclude patients who meet any of the following criteria:

  • Isolated procedures (CABG only or valve)
  • Known hypersensitivity to sodium-selenite or to any of the constituents of the solution.
  • Renal failure requiring dialysis at the point of screening.
  • Chronic liver disease as evidenced by a pre-operative total bilirubin >2 mg/dl or 34 umol/L.
  • Disabling neuropsychiatric disorders (severe dementia, severe Alzheimer's disease, advanced Parkinson's disease).
  • Pregnancy or lactation period.
  • Simultaneous participation in another clinical trial of an experimental therapy (co-enrolment acceptable in observational studies or randomized trials of existing therapies if permitted by both steering committees and local ethics boards).
  • Patients undergoing heart transplantation or preoperative planned LVAD insertion or complex congenital heart surgery.
  • Alternate contacts of investigators (required by German Regulatory Authorities).

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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