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

University Hospital Basel

Status and phase: Completed; Phase 3

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

Treatments: Drug: Selenase

Study type: Interventional

Funder types: Other

Identifiers

NCT01141556

236/09

Details and patient eligibility

About

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.

Full 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

Enrollment: 410 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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410 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Placebo (NaCl) i.v. intraoperatively, followed by an daily bolus of Placebo (NaCl) i.v. until discharge from ICU (no longer than 13 days)

Treatment:

Drug: Selenase

Selenase

Active Comparator group

Description:

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)

Treatment:

Drug: Selenase