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

• Status: Active, not recruiting
• Trial end date: 2021-07-01
• Target enrollment: 0
• Participant gender: All

Summary

The aim of the investigators' research program is to investigate the effects of perioperative high dose selenium supplementation in high-risk cardiac surgical patients undergoing complicated open heart surgery. The investigators hypothesize that the therapeutic strategy tested in this randomized trial may contribute to a fewer complications, less organ injury and fewer deaths. Before the investigators conducted the large definitive trial, they conducted a pilot study to assess the feasibility of the protocol, and are rolling the pilot patients into the definitive trial.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Daren K. Heyland
• Collaborators: biosyn Arzneimittel GmbH; Queen's University; RWTH Aachen University
• Treatments: Selenious Acid; Selenium; Sodium Selenite

Criteria

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).