Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0207104826
Study information
Scientific title
Acronym
Study hypothesis
To measure outcome of selenium replacement in critically ill septic patients.
Ethics approval
Not provided at time of registration
Study design
Single-centre prospective randomized double blind controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Signs and Symptoms: Sepsis
Intervention
1. High selenium
2. Standard selenium
Intervention type
Drug
Phase
Not Specified
Drug names
Selenium
Primary outcome measure
Study of Selenium replacement and outcome in critically ill septic patients.
Secondary outcome measures
Not provided at time of registration
Overall trial start date
17/09/2001
Overall trial end date
31/10/2004
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Critically ill patients within the intensive therapy unit.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
200, 100 in each group
Participant exclusion criteria
1. Age <18yrs
2. Pregnant and lactating women
3. Patients not expected to survive >72 hrs
4. Refusal to participate
5. Chronic renal failure patient who is dialysis dependent
6. Severe gastrointestinal bleeding due to alcoholic liver disease
7. Patients known to have acquired AIDS, Hep B or C
8. Granulocyte count less than 1000/mm3 due to a cause other than sepsis
Recruitment start date
17/09/2001
Recruitment end date
31/10/2004
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Department of Anaesthesia
Liverpool
L7 8XP
United Kingdom
Sponsor information
Organisation
Department of Health
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Royal Liverpool and Broadgreen University Hospitals Trust (UK), No External Funding, NHS R&D Support Funding
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17174015
Publication citations
-
Results
Mishra V, Baines M, Perry SE, McLaughlin PJ, Carson J, Wenstone R, Shenkin A, Effect of selenium supplementation on biochemical markers and outcome in critically ill patients., Clin Nutr, 2007, 26, 1, 41-50, doi: 10.1016/j.clnu.2006.10.003.