Trial Outcomes & Findings for A Registry for Comparing Catheter-Related Infection Rates Among Various Shunt Systems in the Treatment of Hydrocephalus (NCT NCT00280904)
NCT ID: NCT00280904
Last Updated: 2013-03-08
Results Overview
Number of shunt infections occurring in subjects implanted with antibiotic impregnated catheters and standard catheters.
Recruitment status
COMPLETED
Target enrollment
433 participants
Primary outcome timeframe
Implantation to Explant
Results posted on
2013-03-08
Participant Flow
Participant milestones
| Measure |
Ventriculoperitoneal Shunt Patients
Patients receiving a de novo standard or antibiotic (AI) catheter implant or catheter replacement of a prior ventriculoperitoneal shunt.
|
|---|---|
|
Overall Study
STARTED
|
433
|
|
Overall Study
COMPLETED
|
433
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Registry for Comparing Catheter-Related Infection Rates Among Various Shunt Systems in the Treatment of Hydrocephalus
Baseline characteristics by cohort
| Measure |
Ventriculoperitoneal Shunt Patients
n=433 Participants
Patients receiving a de novo standard or antibiotic (AI) catheter implant or catheter replacement of a prior ventriculoperitoneal shunt.
|
|---|---|
|
Age, Categorical
<=18 years
|
183 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
193 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
57 Participants
n=5 Participants
|
|
Age Continuous
|
31.3 years
STANDARD_DEVIATION 25.49 • n=5 Participants
|
|
Sex: Female, Male
Female
|
194 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
239 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Implantation to ExplantNumber of shunt infections occurring in subjects implanted with antibiotic impregnated catheters and standard catheters.
Outcome measures
| Measure |
Ventriculoperitoneal Shunt Patients
n=433 Participants
Patients receiving a de novo antibiotic impregnated(AI)or standard catheter implant or catheter replacement of a prior ventriculoperitoneal shunt.
|
|---|---|
|
Number of Subjects With Shunt Infections
|
14 participants
|
SECONDARY outcome
Timeframe: April 2008Outcome measures
| Measure |
Ventriculoperitoneal Shunt Patients
n=433 Participants
Patients receiving a de novo antibiotic impregnated(AI)or standard catheter implant or catheter replacement of a prior ventriculoperitoneal shunt.
|
|---|---|
|
Non-infectious Antibiotic Impregnated (AI) and Standard Catheter Subjects With Shunt Failures
|
40 participants
|
Adverse Events
Ventriculoperitoneal Shunt Patients
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60