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

Phase 3

Completed

• Conditions: Heart; Surgery, Heart, Functional Disturbance as Result; Self Efficacy
• Interventions: Drug: Selenase

• Registration Number: NCT01141556
• Lead Sponsor: University Hospital, Basel, Switzerland

Brief 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.

Detailed 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 Timeline

• Study First Submitted: 2010-06-08
• Study First Submitted QC: 2010-06-09
• Study First Posted: 2010-06-10
• Study Start: 2010-12
• Primary Completion: 2012-07
• Study Completion: 2012-09
• Status Verified: 2012-10
• Last Update Submitted: 2012-10-24
• Last Update Posted: 2012-10-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 410

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Clinical outcome quantified by using the Sequential Organ Failure Assessment (SOFA) Score	3 days

Secondary Outcome Measures

Name	Time	Method
incidence of acute renal failure	28 days
total requirement of vasoconstrictors	28 days
total requirement of fluid replacement therapy	28 days
length of ICU stay in hours	outcome at 28 days

Trial Locations

Locations (2)

Departement of Anaesthesia and Intensive Care, University Hospital of Basel; 🇨🇭 Basel, Switzerland

Kantonsspital Luzern; 🇨🇭 Lucerne, Switzerland