E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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. |
Germany is a shortage region for Selenium. Especially patients in need of treatment requiring the use of heart-lung-machines have shown a significant decrease of Selenium levels after surgery. Therefore the effect of a perioperative selenum supplementation will be investigated. |
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E.1.1.1 | Medical condition in easily understood language |
patients undergoing cardiac surgery |
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E.1.1.2 | Therapeutic area | Diseases [C] - Cardiovascular Diseases [C14] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To determine the effects of an perioperative selenium supplementation on postoperative recovery in patintes undergoing high-risk cardiac surgery |
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E.2.2 | Secondary objectives of the trial |
- Inflammation and oxidative stress - Quality of Life - Delirium - 30 days mortality - duration of life sustaining therapies
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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)
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E.4 | Principal 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 <50 ml/min and/or severe pre-operative value of serum creatinine level above 200 micromoles/litre (local laboratory). 3) Chronic liver disease as evidenced by a pre-operative total bilirubin >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). |
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E.5 End points |
E.5.1 | Primary end point(s) |
“persistent organ dysfunction+death (PODS+Death)” as a composite endpoint. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Depending on end point (daily evaluation) |
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E.5.2 | Secondary end point(s) |
- inflammation and oxidative stress - Delirium - Quality of life - 30 day mortality - 6-minute walking test (6MWT)
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
during the ICU stay 6MWT at hospital discharge |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 10 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 10 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
Canada |
Germany |
United States |
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E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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LVLS, but there is an additional phone call 3 and 6 month after discharge |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 4 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 4 |
E.8.9.2 | In all countries concerned by the trial months | 6 |
E.8.9.2 | In all countries concerned by the trial days | 0 |