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

Self Efficacy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01141556
• Other study ID #: 236/09
• Status: Completed
• Phase: Phase 3
• First received: June 8, 2010
• Last updated: October 24, 2012
• Start date: December 2010
• Est. completion date: September 2012

Study information

• Verified date: October 2012
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 410
• Est. completion date: September 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Heart; Surgery, Heart, Functional Disturbance as Result
• Pathologic Processes
• Self Efficacy
• Systemic Inflammatory Response Syndrome

Intervention

Drug:
• Selenase
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).

Locations

Country	Name	City	State
Switzerland	Departement of Anaesthesia and Intensive Care, University Hospital of Basel	Basel
Switzerland	Kantonsspital Luzern	Lucerne

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical outcome quantified by using the Sequential Organ Failure Assessment (SOFA) Score		3 days	No
Secondary	length of ICU stay in hours		outcome at 28 days	No
Secondary	incidence of acute renal failure		28 days	No
Secondary	total requirement of vasoconstrictors		28 days	No
Secondary	total requirement of fluid replacement therapy		28 days	No