Silver Impregnated Line Versus External Ventricular Drains (EVD) Randomised Trial
| ISRCTN | ISRCTN29451493 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN29451493 |
| Secondary identifying numbers | Cambridge LREC 04/Q0108/247 |
- Submission date
- 12/09/2005
- Registration date
- 20/12/2005
- Last edited
- 19/09/2012
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Miss Nicole Keong
Scientific
Scientific
Box 166, Department of Neurosurgery
Cambridge University Hospitals NHS Foundation Trust
Hills Road
Cambridge
CB2 2QQ
United Kingdom
Study information
| Study design | Double blind randomised plain controlled parallel group trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Information sheets and consent forms as approved by local ethics committees |
| Scientific title | Silver Impregnated Line Versus EVD Randomised Trial and Cerebrospinal Fluid Infection from the use of External Ventricular Drains |
| Study acronym | SILVER Trial |
| Study objectives | Silver impregnated lines (external ventricular drains with silver lining) cause fewer cerebrospinal fluid (CSF) infections than plain standard EVD catheters. Please note that as of 19/04/10 this trial has been extensively updated. All updates may be found in the relevant field with the above update date. Please also note that the anticipated start and end dates of the trial 01/07/05 to 31/07/07 have been changed to the actual start and end dates 01/06/05 to 31/09/09. A second site, Southampton, also joined the trial after the last recorded update (03/12/07) |
| Ethics approval(s) | Added 19/04/10 1. Cambridge Local Research Ethics Committee approved in February 2005 (ref: 04/Q0108/247) 2. Southampton Local Research Ethics Committee approved in November 2006 |
| Health condition(s) or problem(s) studied | Cerebrospinal fluid infection, external ventricular drains for raised intracranial pressure, ventriculomegaly or hydrocephalus |
| Intervention | Current information as of 19/04/10: Participants were randomised to receive either a silver impregnated EVD or a plain standard EVD for the duration of their EVD requirement to treat raised intracranial pressure, hydrocephalus or ventriculomegaly. Initial information at time of registration: Silver impregnated lines (external ventricular drains with silver lining) versus plain standard EVDs. |
| Intervention type | Other |
| Primary outcome measure | Current information as of 19/04/10: CSF infection as defined by organisms seen on gram stain or grown on culture during the EVD period Initial information at time of registration CSF infection confirmed by culture of organisms |
| Secondary outcome measures | Current information as of 19/04/10: 1. Number of EVD replacements 2. Duration of EVD placement 3. Antibiotic treatment required for CSF infection (confirmed or suspected) 4. Total time from admission to discharge 5. Permanent ventriculoperitoneal (VP) shunt required at 6 months 6. Clinical outcome at discharge (Glasgow Coma Score) Initial information at time of registration: 1. Number of EVD replacements 2. Duration of EVD placement 3. Antibiotic treatment required for CSF infection (confirmed or suspected) 4. Total time from admission to discharge 5. Permanent ventriculoperitoneal (VP) shunt required 6. Clinical outcome at discharge (Glasgow Coma Score) |
| Overall study start date | 01/06/2005 |
| Completion date | 30/09/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 140 in each arm (2 arms) - total 280 |
| Key inclusion criteria | Current information as of 19/04/10: All patients 17 years and over requiring an EVD for management of their intracranial pathology referred to Cambridge University Hospitals NHS Foundation Trust, Cambridge and Wessex Neurological Centre, Southampton Initial information at time of registration: All patients requiring an EVD for management of their intracranial pathology referred to Cambridge University Hospitals NHS Foundation Trust |
| Key exclusion criteria | 1. Patients with a known allergy to silver 2. Patients who are pregnant 3. The presence of infection or dermatitis at the catheter insertion site 4. Known cerebrospinal fluid (CSF) infection (gram-stain or culture of organisms) 5. A previous EVD placement within the previous 30 days 6. Refractory coagulopathy 7. Currently the trial is only open to patients who are 17 years or above |
| Date of first enrolment | 01/06/2005 |
| Date of final enrolment | 30/09/2009 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Box 166, Department of Neurosurgery
Cambridge
CB2 2QQ
United Kingdom
CB2 2QQ
United Kingdom
Sponsor information
Cambridge University Hospitals NHS Foundation Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
Box 166, Department of Neurosurgery
Cambridge University Hospitals NHS Foundation Trust
Cambridge
CB2 2QQ
England
United Kingdom
"ROR" |
https://ror.org/04v54gj93 |
|---|
Funders
Funder type
Government
Current information as of 19/04/10:
No information available
The trial has been run as a clinical investigation involving two neurosurgical units - Cambridge University Hospitals NHS Foundation Trust and Wessex Neurological Centre, Southampton. The trial EVDs were cost-neutral to both trusts as compared to non-study catheters. There was no cost benefit to either the units or the investigators
No information available
Initial information at time of registration:
No information available
The trial is run as a clinical investigation by Cambridge University Hospitals NHS Foundation Trust . The trial EVDs are purchased at the same price as the EVDs currently in clinical use. There is no cost benefit to the investigators.
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/08/2012 | Yes | No |
