Selenium is a key component of a number of selenoproteins which protect against oxidative stress and is well recognised for its prominent role in immune defence. Selenoproteins have the potential to reduce inflammatory reactions e.g. after trauma or in sepsis. Especially patients in need of treatment requiring the use of heart-lung-machines have shown a significant decrease of Selenium levels after surgery. The effect of a perioperative selenum supplementation will be investigated.
Conditions
Interventions
Trade Name: Selenase
Product Name: selenase
Pharmaceutical Form: Injection
Pharmaceutical form of the placebo: Injection
Route of administration of the placebo: Intravenous use
Sponsors
Clinical Evaluation Research Unit (CERU)
Eligibility
Sex/Gender
All
Inclusion 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 b) Any cardiac surgery with a high perioperative risk profile, defined as a predicted operative mortality of = 5% (EuroSCORE II) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 70 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 70
Exclusion criteria
Exclusion criteria: 1) Known hypersensitivity to sodium-selenite or to any of the constituents of the solution. 2)Severe renal dysfunction as evidenced by pre-operative creatinine clearance 2 mg/dl or 34 umol/L 4)Disabling neuropsychiatric disorders (severe dementia, severe Alzheimer’s disease, advanced Parkinson’s disease). 5) Pregnancy or lactation period. 6) Simultaneous participation in another clinical trial of an experimental therapy (co enrollment acceptable in observational studies or randomized trials of existing therapies if permitted by both steering committees and local ethics boards). 7) Patients undergoing heart transplantation or preoperative planned LVAD insertion or complex congenital heart surgery. 8) Family members of investigators (required by German Regulatory Authorities). 9) Selenase supplementation (open-label selenium), not related to the study 10) Inability or unwillingness of individual to give written informed consent (e.g. patients who undergo an urgent cardiac surgery) 11) Isolated procedures (CABG only or valve only) Additional exclusion criteria for the functional outcome assessment sub-study: 1. Not ambulating independently prior to cardiac surgery because of neurological illness or lower extremity impairment (use of gait aid permitted).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the effects of an perioperative selenium supplementation on postoperative recovery in patintes undergoing high-risk cardiac surgery;Secondary Objective: - Inflammation and oxidative stress - Quality of Life - Delirium - 30 days mortality - duration of life sustaining therapies ;Primary end point(s): “persistent organ dysfunction+death (PODS+Death)” as a composite endpoint.;Timepoint(s) of evaluation of this end point: Depending on end point (daily evaluation) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - inflammation and oxidative stress - Delirium - Quality of life - 30 day mortality - 6-minute walking test (6MWT) ;Timepoint(s) of evaluation of this end point: during the ICU stay 6MWT at hospital discharge | — |
Countries
Canada, Germany, United States
Outcome results
None listed