Clinical trial NCT01141556: Effects of High-dose Intravenous Selenium (Selenase®) in Adult Patients Subjected to Elective All-cause Heart Surgery
Official title: Effects of High-dose Intravenous Selenium (Selenase®) on the Systemic Inflammatory Response Syndrome and Related Organ Dysfunction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Heart; Surgery, Heart, Functional Disturbance as Result
Self Efficacy
Keywords: selenium
clinical outcome
heart surgery
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2010-06-10
Enrollment: 410
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: Clinical outcome quantified by using the Sequential Organ Failure Assessment (SOFA) Score
timeFrame: 3 days
Secondary outcomes:
measure: length of ICU stay in hours
timeFrame: outcome at 28 days
measure: incidence of acute renal failure
timeFrame: 28 days
measure: total requirement of vasoconstrictors
timeFrame: 28 days
measure: total requirement of fluid replacement therapy
timeFrame: 28 days
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Departement of Anaesthesia and Intensive Care, University Hospital of Basel
city: Lucerne
country: Switzerland
facility: Kantonsspital Luzern
Study officials:
affiliation: Anästhesie/chirurgische Intensivstation Luzerner Kantonsspital
name: Christoph Haberthuer, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Schmidt T, Pargger H, Seeberger E, Eckhart F, von Felten S, Haberthur C. Effect of high-dose sodium selenite in cardiac surgery patients: A randomized controlled bi-center trial. Clin Nutr. 2018 Aug;37(4):1172-1180. doi: 10.1016/j.clnu.2017.04.019. Epub 2017 May 2.