Condition category
Signs and Symptoms
Date applied
30/09/2005
Date assigned
30/09/2005
Last edited
27/07/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr SM Mostafa

ORCID ID

Contact details

Department of Anaesthesia
12th floor
Royal Liverpool University Hospital
Prescot Street
Liverpool
L7 8XP
United Kingdom

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 measures

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

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

http://www.dh.gov.uk/Home/fs/en

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

Results - basic reporting

Publication summary

2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17174015

Publication citations

  1. 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.

Additional files

Editorial Notes