Effects of High-dose Intravenous Selenium (Selenase®) on the Systemic Inflammatory Response Syndrome and Related Organ Dysfunction
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Enrollment
- 410
- Locations
- 2
- Primary Endpoint
- Clinical outcome quantified by using the Sequential Organ Failure Assessment (SOFA) Score
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Placebo
Placebo (NaCl) i.v. intraoperatively, followed by an daily bolus of Placebo (NaCl) i.v. until discharge from ICU (no longer than 13 days)
Intervention: Selenase (Drug)
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)
Intervention: Selenase (Drug)
Outcomes
Primary Outcomes
Clinical outcome quantified by using the Sequential Organ Failure Assessment (SOFA) Score
Time Frame: 3 days
Secondary Outcomes
- incidence of acute renal failure(28 days)
- length of ICU stay in hours(outcome at 28 days)
- total requirement of vasoconstrictors(28 days)
- total requirement of fluid replacement therapy(28 days)