The British Antibiotic and Silver Impregnated Catheters for ventriculoperitoneal Shunts multi-centre randomised control trial
| ISRCTN | ISRCTN49474281 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN49474281 |
| Secondary identifying numbers | Version 2.0; HTA 10/104/30 |
- Submission date
- 11/12/2012
- Registration date
- 17/12/2012
- Last edited
- 06/02/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nervous System Diseases
Plain English summary of protocol
Background and study aims:
Two new devices have been introduced to try to reduce shunt infection; Bactiseal and Silverline shunts. This study will compare these new shunts to standard shunts. Our goal is to establish which provides most protection against infection and to ensure standardisation of care.
Who can participate?
Children and adults with newly diagnosed hydrocephalus.
What does the study involve?
Patients will be randomly chosen to receive either standard, Bactiseal or Silverline shunts. The patient will have a follow up every three months via the telephone and a questionnaire by post.
What are the possible benefits and risks of participating?
There will be no immediate direct benefit to those taking part. But there should be benefits to future patients requiring this treatment as they will potentially have reduced shunt infection.
The main risk of infection is complications for the patients which can leads to prolonged hospital stay, multiple operations and reduced IQ.
Where is the study run from?
Alder Hey Childrens Hospital NHS Foundation Trust.
When is study starting and how long is it expected to run for?
Recruitment will start in early 2013, for 2 years. Patients will be followed up for a maximum of 2.5 years.
Who is funding the study?
National Institute of Health Research Health Technology Assessment Programme
Who is the main contact?
Mr Tom Kearns
thomas.kearns@liv.ac.uk
Contact information
Scientific
Alder Hey Childrens NHS Foundation Trust
Eaton Road
Liverpool
L12 2AP
United Kingdom
Study information
| Study design | Three-arm multi-centre phase III randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | National three-arm, double blind multi-centre randomised controlled trial comparing Bactiseal (antibiotic-impregnated), Silverline (silver-impregnated) and standard (non-impregnated) VPS in patients with newly diagnosed hydrocephalus undergoing insertion of their first permanent shunt |
| Study acronym | BASICS |
| Study objectives | Shunt failure due to infection has plagued this neurosurgical advance ever since it was developed. The incidence of shunt infection varies markedly in the literature from 3-27% (2-6) and is higher in certain groups, e.g. neonates and children under 1 year old, patients treated with a previous temporary external ventricular drain (EVD). Episodes of shunt infection have a significant impact on patients and the NHS and require prolonged inpatient hospitalisation, additional surgery to remove the infected hardware, placement of a temporary EVD, intravenous and intrathecal antibiotics, and further surgery to place a new shunt once the infection has been treated. Other clinical consequences of infection including epilepsy, reduced IQ and loculation have often been reported but never formally studied in the context of a prospective clinical trial. This trial thus addresses the primary question of which shunt catheter is most effective in reducing shunt infection and also has secondary questions addressing the consequences of infection in a clinical and financial context. More details can be found here: http://www.hta.ac.uk/project/2902.asp |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Newly diagnosed hydrocephalus |
| Intervention | We will randomly allocate patients to a standard non impregnated ventriculoperitoneal shunt (VPS), a Silverline (Silver impregnated) VPS or a Bactiseal (antiobiotic impregnated) VPS on a ratio of 1:1:1. All VPS used for the trial are CE marked medical devices being used for their intended purpose. |
| Intervention type | Device |
| Pharmaceutical study type(s) | |
| Phase | Phase III |
| Drug / device / biological / vaccine name(s) | |
| Primary outcome measure | Early infection (within 6 months) following insertion of the first de novo VPS |
| Secondary outcome measures | 1. The proportion of delayed VPS infections (occurring > 6 months following de novo insertion) 2. Which organisms and their resistance/sensitivities, subsequently infect these three alternative VPS 3. The clinical impact of each VPS infection 4. The infection rate following the first (non-infected) clean VPS revision for mechanical failure 5. The cost-effectiveness and health economics of antibiotic and silver impregnated VPS compared to standard VPS 6. The diagnostics of suspected shunt infections through molecular diagnostic approaches |
| Overall study start date | 01/03/2013 |
| Completion date | 01/08/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 1200 |
| Total final enrolment | 1605 |
| Key inclusion criteria | 1. Newly diagnosed hydrocephalus of any aetiology (including idiopathic intracranial hypertension) 2. VPS is the primary treatment option 3. Clear CSF sample at the time of shunt insertion 3.1. Failed primary endosopic third ventriculostomy allowed 3.2. Previous indwelling ventricular access device (e.g. Ommaya or Rickham reservoir or similar) allowed 3.3. Previous indwelling EVD allowed |
| Key exclusion criteria | 1. Previous indwelling VPS 2. Active and on-going CSF or peritoneal infection 3. Multi-loculated hydrocephalus requiring multiple VPS or neuro-endoscopy 4. Ventriculo-atrial or ventriculo-pleural shunt planned 5. Allergy to antibiotics associated with the antibiotic shunt |
| Date of first enrolment | 01/03/2013 |
| Date of final enrolment | 01/08/2013 |
Locations
Countries of recruitment
- England
- Ireland
- United Kingdom
Study participating centre
L12 2AP
United Kingdom
Sponsor information
Hospital/treatment centre
Eaton Road
Liverpool
L12 2AP
England
United Kingdom
| Phone | +44 (0)151 252 5673 |
|---|---|
| Katherine.jopson@alderhey.nhs.uk | |
| Website | http://www.alderhey.nhs.uk/ |
"ROR" |
https://ror.org/00p18zw56 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- NIHR Health Technology Assessment Programme, HTA
- Location
- United Kingdom
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 | Not provided at time of registration |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 03/01/2014 | Yes | No | |
| Results article | results | 26/10/2019 | 17/09/2019 | Yes | No |
| Results article | results | 01/03/2020 | 03/04/2020 | Yes | No |
| Results article | Post hoc analysis | 01/02/2023 | 06/02/2023 | Yes | No |
Editorial Notes
06/02/2023: Publication reference added.
03/04/2020: Publication reference added.
17/09/2019: Publication reference and total final enrolment added.
01/03/2019: Internal review.
03/10/2018: No publications found, verifying study status with principal investigator.
