Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials
Text Size

A Registry for Comparing Catheter-Related Infection Rates Among Various Shunt Systems in the Treatment of Hydrocephalus

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Codman & Shurtleff
ClinicalTrials.gov Identifier:
NCT00280904
First received: January 20, 2006
Last updated: February 5, 2013
Last verified: February 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Hydrocephalus
 Device: Shunt catheter
 Phase 4

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Registry for Comparing Catheter-Related Infection Rates Among Various Shunt Systems in the Treatment of Hydrocephalus

Resource links provided by NLM:

MedlinePlus related topics: Hydrocephalus
U.S. FDA Resources

Further study details as provided by Codman & Shurtleff:

Primary Outcome Measures:
  • Number of Subjects With Shunt Infections [ Time Frame: Implantation to Explant ] [ Designated as safety issue: No ]
    Number of shunt infections occurring in subjects implanted with antibiotic impregnated catheters and standard catheters.


Secondary Outcome Measures:
  • Non-infectious Antibiotic Impregnated (AI) and Standard Catheter Subjects With Shunt Failures [ Time Frame: April 2008 ] [ Designated as safety issue: No ]
Enrollment: 433
Study Start Date: January 2006
Study Completion Date: April 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Shunt catheter
    standard of care implantation of shunt (any brand). Subjects are followed for 90 days to obtain information about whether or not an infection occurred.
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
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Subjects of any age, gender and ethnicity, with hydrocephalus

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00280904

Locations
United States, Illinois
Children's memorial Hospital
Chicago, Illinois, United States, 60614
United States, Pennsylvania
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
Canada, British Columbia
British Columbia Children's Hospital
Vancouver, British Columbia, Canada, V6H 3V4
China
Prince of Wales Hospital
Beijing, China
Ua Shan Hospital
Shanghai, China, 200040
Hong Kong
Queen Mary Hospital
Hong Kong, Hong Kong
India
All India Insitute of Medical Sciences
New Delhi, India, 110029
Singapore
National Neuroscience Institute
Singapore, Singapore, 308433
Sponsors and Collaborators
Codman & Shurtleff
Investigators
Study Chair: Paul Steinbok, MBBS, FRCSC University of British Columbia
  More Information

Publications:

Responsible Party: Codman & Shurtleff
ClinicalTrials.gov Identifier: NCT00280904     History of Changes
Other Study ID Numbers: CRI-IN04-001
Study First Received: January 20, 2006
Results First Received: November 17, 2010
Last Updated: February 5, 2013
Health Authority: United States: Food and Drug Administration
Canada: Ethics Review Committee

Keywords provided by Codman & Shurtleff:
Hydrocephalus
Shunt

Additional relevant MeSH terms:
Catheter-Related Infections
Hydrocephalus
Brain Diseases
Central Nervous System Diseases
 Infection
Intracranial Hypertension
Nervous System Diseases

ClinicalTrials.gov processed this record on February 27, 2015