Does Selenium Supplementation reduce Oxidative Stress associated with Subarachnoid Haemorrhage? - Selenium and Subarachnoid Haemorrhage

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2005-004684-31-GB

Enrollment

Registered

2006-01-17

Start date

2006-04-20

Completion date

Unknown

Last updated

2020-10-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

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 Co

Eligibility

Sex/Gender

All

Inclusion 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

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

Design outcomes

Primary

Measure	Time frame
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	—

Measure

Time frame

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

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Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026