Effects of High-dose Intravenous Selenium (Selenase®) in Adult Patients Subjected to Elective All-cause Heart Surgery

Study Overview
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Brief Summary
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Selenoenzymes play a major role in protecting cells against lipid peroxidation and they are involved in the inflammatory response regulation. The degree of selenium deficiency correlates with disease severity and the incidence of mortality in critically ill patients. The aim of our study is to evaluate, if high dosis selenium supplementation (loading dose 4000 μg, daily dosage 1000 μg) results in a significant reduction of inflammation-induced organ dysfunction and length of ICU-stay in patients after heart surgery.

Detailed Description
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Selenium is a essential micronutrient that is present in form of selenocysteine in many enzymes. Selenoenzymes play a major role in protecting cells against lipid peroxidation and they are involved in the inflammatory response regulation. The degree of selenium deficiency correlates with disease severity and the incidence of mortality. Different studies showed that selenium supplementation had beneficial effects in critically ill patients with systemic inflammatory response syndrome (SIRS), reducing the rate of infectious complications and length of hospital stay. Heart surgery is associated with a complex systemic inflammatory response and the extent correlates with the development of postoperative complications. Former clinical trials used selenium supplementation with a loading dose of normally 1000 to 2000 μg, followed by a daily dosage of 1000 μg. With these dosage regimes pharmacological investigations demonstrated a delayed increase of the selenium concentration in plasma and whole blood. As a result a delayed increase of selenoenzymes can be assumed. Aim of our study is to evaluate, if high dosis selenium supplementation (loading dose 4000 μg, daily dosage 1000 μg) results in a significant reduction of inflammation-induced organ dysfunction and length of ICU-stay in patients after heart surgery. Primary endpoints are: Clinical outcome quantified by using the Sequential Organ Failure Assessment (SOFA) Score and the length of ICU stay in hours. Secondary endpoints are: incidence of acute renal failure, total requirement of vasoconstrictors and fluid replacement therapy Inclusion criteria: written informed consent, males and females age ≥ 18 years, patients undergoing an elective heart surgery, normal renal function (serum creatinine ≤ 200 μmol/l) Exclusion criteria: pregnancy, lack of written concent, emergency operation

Official Title
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Effects of High-dose Intravenous Selenium (Selenase®) on the Systemic Inflammatory Response Syndrome and Related Organ Dysfunction

Conditions
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Heart; Surgery, Heart, Functional Disturbance as Result, Self Efficacy

Intervention / Treatment
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* Drug: Selenase


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: written informed consent males and females age ≥ 18 years patients undergoing an elective heart surgery normal renal function (serum creatinine ≤ 200 μmol/l) Exclusion Criteria: pregnancy lack of written concent emergency operation

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Placebo (NaCl) i.v. intraoperatively, followed by an daily bolus of Placebo (NaCl) i.v. until discharge from ICU (no longer than 13 days) | Drug: Selenase<br>* After enrollment, patients will be prospectively randomized into two groups: a placebo group without selenium and a group receiving a loading dose of selenium 4000 μg intraoperatively,followed by a daily dosage of 1000 μg until leaving the ICU (longest supplementation 13 days).<br>* Other names: Selenase: Selenium;|
| Active Comparator: Selenase<br>Selenase Bolus 4000 microgram i.v. intraoperatively, followed by an daily bolus of Selenase 1000 microgram i.v. until discharge from ICU (no longer than 13 days) | Drug: Selenase<br>* After enrollment, patients will be prospectively randomized into two groups: a placebo group without selenium and a group receiving a loading dose of selenium 4000 μg intraoperatively,followed by a daily dosage of 1000 μg until leaving the ICU (longest supplementation 13 days).<br>* Other names: Selenase: Selenium;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical outcome quantified by using the Sequential Organ Failure Assessment (SOFA) Score |  | 3 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| length of ICU stay in hours |  | outcome at 28 days | 
| incidence of acute renal failure |  | 28 days | 
| total requirement of vasoconstrictors |  | 28 days | 
| total requirement of fluid replacement therapy |  | 28 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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selenium, clinical outcome, heart surgery