NCT01394068

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2011

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 12, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 14, 2011

Completed
18 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
Last Updated

August 18, 2011

Status Verified

August 1, 2011

Enrollment Period

7 months

First QC Date

July 12, 2011

Last Update Submit

August 17, 2011

Conditions

Selenium Deficiency

Keywords

Selenium levelVarious blood valuesDuration of artificial respirationResidence in ICU/ HospitalSOFA-ScoreSAPS-Score

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Approximately 100 adult patients (male and female), capable of consenting, undergoing elective cardiac surgery on the heart-lung-machine

You may qualify if:

  • Age of 18 years or older
  • Elective heart surgery on the heart-lung-machine
  • Written informed consent

You may not qualify if:

  • Patients not capable of consenting
  • pregnant women or women of child-bearing potential

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Aachen

Aachen, 52074, Germany

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Procalcitonin, CRP, IL-6, IL-10, Leukocytes, Thrombocytes, Bilirubin, Creatinine, Lactate, Albumin, AT-III

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 12, 2011

First Posted

July 14, 2011

Study Start

January 1, 2011

Primary Completion

August 1, 2011

Study Completion

August 1, 2011

Last Updated

August 18, 2011

Record last verified: 2011-08

Locations

DE(1)