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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier:
NCT01141556
First received: June 8, 2010
Last updated: October 24, 2012
Last verified: October 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Heart; Surgery, Heart, Functional Disturbance as Result
Self Efficacy
 Drug: Selenase
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of High-dose Intravenous Selenium (Selenase®) on the Systemic Inflammatory Response Syndrome and Related Organ Dysfunction

Resource links provided by NLM:

MedlinePlus related topics: Heart Surgery
U.S. FDA Resources

Further study details as provided by University Hospital, Basel, Switzerland:

Primary Outcome Measures:
  • Clinical outcome quantified by using the Sequential Organ Failure Assessment (SOFA) Score [ Time Frame: 3 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • length of ICU stay in hours [ Time Frame: outcome at 28 days ] [ Designated as safety issue: No ]
  • incidence of acute renal failure [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • total requirement of vasoconstrictors [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • total requirement of fluid replacement therapy [ Time Frame: 28 days ] [ Designated as safety issue: No ]

Enrollment: 410
Study Start Date: December 2010
Study Completion Date: September 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 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)
 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).
Other Name: Selenase: Selenium
Active Comparator: 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).
Other Name: Selenase: Selenium

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01141556

Locations
Switzerland
Departement of Anaesthesia and Intensive Care, University Hospital of Basel
Basel, Switzerland
Kantonsspital Luzern
Lucerne, Switzerland, 6016
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Investigators
Principal Investigator: Christoph Haberthuer, MD Anästhesie/chirurgische Intensivstation Luzerner Kantonsspital
  More Information

No publications provided

Responsible Party: University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT01141556     History of Changes
Other Study ID Numbers: 236/09
Study First Received: June 8, 2010
Last Updated: October 24, 2012
Health Authority: Switzerland: Swissmedic

Keywords provided by University Hospital, Basel, Switzerland:
selenium
clinical outcome
heart surgery

Additional relevant MeSH terms:
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Shock
Selenium
Trace Elements
Micronutrients
 Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents

ClinicalTrials.gov processed this record on June 18, 2013