Prospective, Non-randomized Observational Trial of Selenium in Cardiac Surgery
Information source: RWTH Aachen University
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Selenium Deficiency
Phase: N/A
Status: Completed
Sponsored by: RWTH Aachen University
Summary
In this observational study the effect of selenium supplementation on the postoperative
inflammatory response and clinical course should be examined in (approximately 100) adult
patients undergoing elective heart surgery combined with extracorporeal circulation.
Selenium is one of the essential trace elements with a variety of important immunological
and antioxidant properties. The pathophysiological relevance of different selenium-dependent
reactions has already been demonstrated in human and in animal experiments. It is
essential for the enzymatic functions of selenium-containing proteins such as the
glutathione peroxidase, which in turn affects the leukotriene, thromboxane and prostacyclin
metabolism. In addition, selenium has a significant influence on various liver enzymes,
therefore selenium deficiency leads to oxidative or chemically induced liver damage.
Clinical Details
Official title: SICS: A Prospective, Non-randomized Observational Trial of Selenium in Cardiac Surgery
Study design: Observational Model: Cohort, Time Perspective: Prospective
Detailed description:
Heart Surgery on the heart-lung machine involves, inter alia, by ischemia and reperfusion,
the release of reactive oxygen radicals and nitrogen oxide (NO), which damage DNA after
reaction with peroxynitrite, and Lipid-/Endothelmembrane Protein. The formation and
consumption of peroxynitrite can be reduced by intake of sodium selenite and the subsequent
formation of selenoprotein P. Since there is no storage for selenium, but the synthesis of
selenium-dependent enzymes is regulated by selenium resorption, the supplementation of
selenium is a potentially useful application in patients undergoing cardiac surgery.
After induction of anaesthesia and before connecting to the heart-lung machine the patients
get applied 2000μg sodium selenite (Selenase® T pro injection) intravenously (as a bolus
infusion over 30 minutes).
Furthermore, they get infused 1000μg sodium-selenite on each ICU-treatment day (also about
30 minutes). In addition, various blood values are recorded daily (including selenium
levels) within the routine blood samples. As the collection of these parameters is necessary
anyway, it constitutes no additional burden on the patient. Shortly before the transfer to
general ward there will be a final clinical examination.
In case of selenium level of 170μg per liter whole blood the employee of the laboratory
immediately informs the investigator by fax and requests a new blood sample for control
purposes (reference value for selenium in whole blood according to product information
100-144µg/ l). As long as the selenium level of the second sample is not higher than 230μg
selenium per liter whole blood, there are no further precautions necessary according to the
manufacturer`s recommendations. In case of selenium level above 230μg /l, the investigator
will be informed by fax without delay and the donation of investigational product will be
interrupted immediately. If a patient shows clinical signs of selenium toxicity (garlic-like
breath odor, fatigue, nausea, diarrhea, abdominal pain) it occurs an immediate termination
of the selenium dose, initiating symptomatic counteractive measures and further control
samples.
All blood samples are taken by vascular catheters, which are already set for surgery or for
intensive care treatment, independent of the observational study.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Age of 18 years or older
- Elective heart surgery on the heart-lung-machine
- Written informed consent
- Inclusion into observational study at the latest on the last evening before surgery
Exclusion Criteria:
- Patients not capable of consenting
- pregnant women or women of child-bearing potential
Locations and Contacts
University Hospital Aachen, Aachen 52074, Germany
Additional Information
Starting date: January 2011
Last updated: August 17, 2011
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