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

2014-08-27 03:13:01 | BioPortfolio

Summary

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.

Description

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Conditions

Heart Surgical Procedures

Intervention

selenium

Location

Departement of Anaesthesia and Intensive Care, University Hospital of Basel
Basel
Switzerland

Status

Not yet recruiting

Source

University Hospital, Basel, Switzerland

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:13:01-0400

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Medical and Biotech [MESH] Definitions

A selenium compound used as a source of SELENIUM, especially for patients that develop selenium deficiency following prolonged PARENTERAL NUTRITION.

Surgical procedures performed using a computer that remotely controls surgical instruments attached to mechanical arms designed to perform the tasks of the surgeon.

Agents that have a strengthening effect on the heart or that can increase cardiac output. They may be CARDIAC GLYCOSIDES; SYMPATHOMIMETICS; or other drugs. They are used after MYOCARDIAL INFARCT; CARDIAC SURGICAL PROCEDURES; in SHOCK; or in congestive heart failure (HEART FAILURE).

Unstable isotopes of selenium that decay or disintegrate emitting radiation. Se atoms with atomic weights 70-73, 75, 79, 81, and 83-85 are radioactive selenium isotopes.

A group of proteins that covalently attach to selenium or SELENIUM-containing compounds.

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