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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	EUCTR
Last refreshed on:	13 October 2020
Main ID:	EUCTR2005-004684-31-GB
Date of registration:	17/01/2006
Prospective Registration:	Yes
Primary sponsor:	Barts and the London NHS Trust
Public title:	Does Selenium Supplementation reduce Oxidative Stress associated with Subarachnoid Haemorrhage? - Selenium and Subarachnoid Haemorrhage
Scientific title:	Does Selenium Supplementation reduce Oxidative Stress associated with Subarachnoid Haemorrhage? - Selenium and Subarachnoid Haemorrhage
Date of first enrolment:	20/04/2006
Target sample size:	45
Recruitment status:	Not Recruiting
URL:	https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2005-004684-31
Study type:	Interventional clinical trial of medicinal product
Study design:	Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no
Phase:	Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment
United Kingdom

Contacts

Name:
Address:
Telephone:
Email:
Affiliation:

Name:
Address:
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Key inclusion & exclusion criteria

Inclusion criteria:
Age 18-70
Hunt and Hess (1974) Subarachnoid haemorrhage Grade 3-5
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
Preganccy
Pre-existing renal failure
Pre-existing hepatic failure
Participation in other intervention trials in the past 30 days
Refusal of consent from the patient or assent from the next of kin
Foreseeable imminent death

Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Patients with spontaneous subarachnoid haemorrhage (non-traumatic) admitted to the Intensive Vare Unit of the Royal London Hospital.

Intervention(s)

Trade Name: Selenase
Product Name: selenase
Pharmaceutical Form: Intravenous infusion
INN or Proposed INN: Sodium selenite pentahydrate
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 500-
Pharmaceutical form of the placebo: Intravenous infusion
Route of administration of the placebo: Intravenous use

Trade Name: Selenase
Pharmaceutical Form: Intravenous infusion
INN or Proposed INN: sodium selenite pentahydrate
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 1000-
Pharmaceutical form of the placebo: Intravenous infusion
Route of administration of the placebo: Intravenous use

Primary Outcome(s)

Main Objective: The mortality of patients with subarachnoid haemorrhage admitted to the Intensive Care Unit is about 25%. Studies of patients with severe burns and sepsis(infection) have shown that when they are admitted to the intensive care unit, the selenium levels are very low. Our primary objective is to demonstrate that by administering selenium to subarachnoid haemorrhage patients, we can raise selenium levels to normal.

Secondary Objective: In the body selenium helps the activity of an enzyme called gluthathione peroxidase. This enzyme is used to remove toxic substances from the body. These toxic substances build up in critically ill patients. This is especially true in subarachnoid haemorrhage patients where there is spasm of the blood vessels supplying the brain resulting in ischaemia. We will measure the gluthathione peroxidase activity in the selenium group of patients and compare it to the control group

We will also seek information on
-mortality
-Duration of antibiotics
-Number of days on ventilator
-Length of intensive care unit stay
-Length of hospital stay
-Adverse events

Primary end point(s): Plasma selenium lebvels

Secondary Outcome(s)

Secondary ID(s)

2809SELENIUM

Source(s) of Monetary Support

Secondary Sponsor(s)

Ethics review

Status: Approved
Approval date: 28/02/2006
Contact:

Results

Results available:	Yes
Date Posted:	18/12/2019
Date Completed:	28/02/2007
URL:	https://www.clinicaltrialsregister.eu/ctr-search/trial/2005-004684-31/results

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