HydrocephalusNCT00280904
A Registry for Comparing Catheter-Related Infection Rates Among Various Shunt Systems in the Treatment of Hydrocephalus
An observational study of Hydrocephalus, run by Codman & Shurtleff at 8 sites in 6 countries.
Trial summary
The purpose of this Registry is to compare shunt/catheter-related infection rates among various shunt systems when used according to hospital standard of care to treat hydrocephalus. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hydrocephalus
- What is being tested?
- Shunt catheter
- Type of treatment
- Medical device
- How many people
- 433 participants
- Where
- 8 sitesin 6 countries
- Study dates
- Jan 2006to Apr 2008
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Subjects of any age, gender and ethnicity, with hydrocephalus
Who may be able to join
- The Subject requires a surgical procedure to implant (de novo) a ventriculoperitoneal shunt or to replace an already implanted shunt catheter for the treatment of hydrocephalus.
- The Subject (family member/legal representative) has completed the Informed Consent process prior to enrollment into this Registry.
- The Subject (family member/legal representative) is willing to comply with the Registry protocol timelines \& requirements.
Who cannot join
- The Subject's planned shunt has distal drainage to the heart.
- The Subject has an active infection of the indwelling shunt system, cerebrospinal fluid or abdominal cavity.
- The Subject has ventriculitis, peritonitis or meningitis.
- The Subject has sepsis.
- The Subject has a history of poor wound healing.
- The Subject has symptoms pertaining to: a skin infection at or near the site of any incisions; an ear infection on either side; a respiratory tract infection; or a urinary tract infection that, in the Investigator's opinion is clinically significant and might compromise the outcome of this Registry.
Show all 12Show fewer
- The Subject has had any form of bowel surgery 30 days prior to device implant or anticipates bowel surgery within 90 days following device implant
- The Subject has loculation(s) within the ventricular system.
- The Subject is otherwise determined by the Investigator to be medically unsuitable for participation in this Registry.
- The Subject is currently enrolled in another drug or device trial or has been previously entered in this trial.
- The Subject exhibits other difficulties, which would preclude follow-up for 90 days.
- The Subject is a prisoner.
Trial locations and contacts
8 sites in 6 countries.
8 sites in 6 countries
United States2 sites
Children's memorial Hospital
Chicago, Illinois, 60614
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033
Canada1 site
British Columbia Children's Hospital
Vancouver, British Columbia, V6H 3V4
About this study
The purpose of this Registry is to compare shunt/catheter-related infection rates among various shunt systems when used according to hospital standard of care to treat hydrocephalus.
Read the detailed description
Clinical trials show that the majority of infections in shunt systems originate from bacterial contamination introduced at the time of surgery and most appear by 3-4 weeks post-operatively. Protection must persist well beyond the surgical procedure to make certain that all contaminating bacteria are completely eradicated.
Depending upon the institution, shunt infection rates have been known to be as little as 1% to as much as 25%. However, two prospective trials that have been published from large databases, with a consistent definition of infection, have indicated an overall infection rate of approximately 10%
This prospective non-randomized, open-label Registry is designed to investigate and identify short-term shunt/catheter-related infection rates in ventriculoperitoneal shunt systems using various catheters during hospital standard of care treatment of Subjects with hydrocephalus. Prospective Subjects will include those receiving shunts for the first time (de novo) and those with previously implanted shunts for whom catheter or total system replacements are required.
This Registry will enroll 450 implanted Subjects of any age who meet all the inclusion criteria and none of the exclusion criteria and who provide signed Informed Consent to participate in this clinical Registry
Subjects will be followed for up to 90 days.
- Conditions
- Hydrocephalus
- Being tested
- Shunt catheter
- Keywords
- Hydrocephalus, Shunt
- Medical subject headings
- Hydrocephalus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shunt catheterDevice
standard of care implantation of shunt (any brand). Subjects are followed for 90 days to obtain information about whether or not an infection occurred.
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects With Shunt Infections
Number of shunt infections occurring in subjects implanted with antibiotic impregnated catheters and standard catheters.
Measured: Implantation to Explant
Secondary outcomes (1)
Non-infectious Antibiotic Impregnated (AI) and Standard Catheter Subjects With Shunt Failures
Measured: April 2008
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2006 (estimated)
- Study startJan 2006
- Primary completionApr 2008
- Study completionApr 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HydrocephalusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 433 participants (actual)
Sponsor and investigators
- Lead sponsor
- Codman & Shurtleff
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Paul Steinbok, MBBS, FRCSC, Study chair, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00280904
- Sponsor's protocol ID
- CRI-IN04-001
- Status last verified
- Feb 2013
- First submitted
- 20 Jan 2006
- Last updated
- 8 Mar 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Steinbok P, Milner R, Agrawal D, Farace E, Leung GK, Ng I, Tomita T, Wang E, Wang N, Wong GK, Zhou LF. A multicenter multinational registry for assessing ventriculoperitoneal shunt infections for hydrocephalus. Neurosurgery. 2010 Nov;67(5):1303-10. doi: 10.1227/NEU.0b013e3181f07e76.
PubMed 20871445
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Registry for Comparing Catheter-Related Infection Rates Among Various Shunt Systems in the Treatment of Hydrocephalus
- ClinicalTrials.gov ID
- NCT00280904
- Acronym / sponsor ID
- CRI-IN04-001
- Conditions
- Hydrocephalus
- Keywords
- Hydrocephalus, Shunt
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 433 participants (actual)
- Lead sponsor
- Codman & ShurtleffIndustry (pharma, biotech, devices)
- Study start
- Jan 2006
- Primary completion
- Apr 2008 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 24 Jan 2006 (estimated)
- Results
- Posted 8 Mar 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this Registry is to compare shunt/catheter-related infection rates among various shunt systems when used according to hospital standard of care to treat hydrocephalus.
Detailed description
Clinical trials show that the majority of infections in shunt systems originate from bacterial contamination introduced at the time of surgery and most appear by 3-4 weeks post-operatively. Protection must persist well beyond the surgical procedure to make certain that all contaminating bacteria are completely eradicated.
Depending upon the institution, shunt infection rates have been known to be as little as 1% to as much as 25%. However, two prospective trials that have been published from large databases, with a consistent definition of infection, have indicated an overall infection rate of approximately 10%
This prospective non-randomized, open-label Registry is designed to investigate and identify short-term shunt/catheter-related infection rates in ventriculoperitoneal shunt systems using various catheters during hospital standard of care treatment of Subjects with hydrocephalus. Prospective Subjects will include those receiving shunts for the first time (de novo) and those with previously implanted shunts for whom catheter or total system replacements are required.
This Registry will enroll 450 implanted Subjects of any age who meet all the inclusion criteria and none of the exclusion criteria and who provide signed Informed Consent to participate in this clinical Registry
Subjects will be followed for up to 90 days.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Subjects of any age, gender and ethnicity, with hydrocephalus
Key inclusion criteria (3 listed)
- The Subject requires a surgical procedure to implant (de novo) a ventriculoperitoneal shunt or to replace an already implanted shunt catheter for the treatment of hydrocephalus.
- The Subject (family member/legal representative) has completed the Informed Consent process prior to enrollment into this Registry.
- The Subject (family member/legal representative) is willing to comply with the Registry protocol timelines \& requirements.
Key exclusion criteria (12 listed)
- The Subject's planned shunt has distal drainage to the heart.
- The Subject has an active infection of the indwelling shunt system, cerebrospinal fluid or abdominal cavity.
- The Subject has ventriculitis, peritonitis or meningitis.
- The Subject has sepsis.
- The Subject has a history of poor wound healing.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Shunt catheterstandard of care implantation of shunt (any brand). Subjects are followed for 90 days to obtain information about whether or not an infection occurred. | Device | – |
Primary outcome
Number of Subjects With Shunt Infections
Time frame: Implantation to Explant
Number of shunt infections occurring in subjects implanted with antibiotic impregnated catheters and standard catheters.
1 secondary outcome
Non-infectious Antibiotic Impregnated (AI) and Standard Catheter Subjects With Shunt Failures
Time frame: April 2008
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 20871445Steinbok P, Milner R, Agrawal D, Farace E, Leung GK, Ng I, Tomita T, Wang E, Wang N, Wong GK, Zhou LF. A multicenter multinational registry for assessing ventriculoperitoneal shunt infections for hydrocephalus. Neurosurgery. 2010 Nov;67(5):1303-10. doi: 10.1227/NEU.0b013e3181f07e76.
Related trials for Hydrocephalus
RecruitingPhase 2
CEUS Evaluation of Hydrocephalus in Neonates and Infants
Hydrocephalus in Infants, Hydrocephalus Acquired
RecruitingObservational study
CoMind Early Feasibility Study
Intracranial Pressure, Intracranial Pressure Changes
RecruitingObservational study
Natural History of Treated Neurocysticercosis and Long-Term Outcomes
Cysticercosis, Neurocysticercosis
RecruitingObservational study
Development of Non-Invasive Prenatal Diagnosis for Single Gene Disorders
Invasive PreNatal Diagnosis in a Context of Family History of Single-gene Disorders, Including, Sickle Cell Disease
Active, not recruiting
HCRN Endoscopic Versus Shunt Treatment of Hydrocephalus in Infants
Hydrocephalus
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul Steinbok, MBBS, FRCSC study chair
University of British Columbia
8 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hydrocephalus, run by Codman & Shurtleff at 8 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States, China, Canada, Hong Kong, India and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Mar 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Subjects With Shunt Infections (time frame: Implantation to Explant). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00280904, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2013.