Clinical trial NCT00280904: A Registry for Comparing Catheter-Related Infection Rates Among Various Shunt Systems in the Treatment of Hydrocephalus
Official title: A Registry for Comparing Catheter-Related Infection Rates Among Various Shunt Systems in the Treatment of Hydrocephalus
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hydrocephalus
Keywords: Hydrocephalus
Shunt
Lead sponsor: Codman & Shurtleff
Sponsor class: INDUSTRY
First posted: 2006-01-24
Enrollment: 433
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects of any age, gender and ethnicity, with hydrocephalus

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.
* 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.

Primary outcomes:
measure: Number of Subjects With Shunt Infections
timeFrame: Implantation to Explant
Secondary outcomes:
measure: Non-infectious Antibiotic Impregnated (AI) and Standard Catheter Subjects With Shunt Failures
timeFrame: April 2008
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Children's memorial Hospital
state: Illinois
city: Hershey
country: United States
facility: Penn State Milton S. Hershey Medical Center
state: Pennsylvania
city: Vancouver
country: Canada
facility: British Columbia Children's Hospital
state: British Columbia
city: Beijing
country: China
facility: Prince of Wales Hospital
city: Shanghai
country: China
facility: Ua Shan Hospital
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital
city: New Delhi
country: India
facility: All India Insitute of Medical Sciences
city: Singapore
country: Singapore
facility: National Neuroscience Institute
Study officials:
affiliation: University of British Columbia
name: Paul Steinbok, MBBS, FRCSC
role: STUDY_CHAIR
References:
citation: 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.