Selenium replacement and outcome in critically ill septic patients.

ISRCTN	ISRCTN20492006
DOI	https://doi.org/10.1186/ISRCTN20492006
Protocol serial number	N0207104826
Sponsor	Department of Health
Funder	Royal Liverpool and Broadgreen University Hospitals Trust (UK), No External Funding, NHS R&D Support Funding

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr SM Mostafa
Scientific

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

Primary study design	Interventional
Study design	Single-centre prospective randomized double blind controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	To measure outcome of selenium replacement in critically ill septic patients.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Signs and Symptoms: Sepsis
Intervention	1. High selenium 2. Standard selenium
Intervention type	Drug
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Selenium
Primary outcome measure(s)	Study of Selenium replacement and outcome in critically ill septic patients.
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	31/10/2004

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	200
Key inclusion criteria	Critically ill patients within the intensive therapy unit.
Key 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
Date of first enrolment	17/09/2001
Date of final enrolment	31/10/2004

Department of Anaesthesia

Liverpool
L7 8XP
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/02/2007		Yes	No