A Phase 3 interventional study of Selenase in Heart; Surgery, Heart, Functional Disturbance as Result and Self Efficacy, sponsored by University Hospital, Basel, Switzerland. Completed at 2 sites in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-10-25.
Sponsored by University Hospital, Basel, Switzerland · Phase 3, Interventional, and Treatment
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.
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
University Hospital, Basel, Switzerland is the lead sponsor of 968 studies on the registry; 191 are open to participants now.
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Exclusion Criteria:
Placebo (NaCl) i.v. intraoperatively, followed by an daily bolus of Placebo (NaCl) i.v. until discharge from ICU (no longer than 13 days)
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)
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).
Also known as: Selenase: Selenium
Clinical outcome quantified by using the Sequential Organ Failure Assessment (SOFA) Score
Time frame: 3 days
length of ICU stay in hours
Time frame: outcome at 28 days
incidence of acute renal failure
Time frame: 28 days
total requirement of vasoconstrictors
Time frame: 28 days
total requirement of fluid replacement therapy
Time frame: 28 days
This study is completed, as verified in Oct 2012. You cannot join it, but the record below documents what was studied.
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University Hospital, Basel, Switzerland