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Cefazolin Antibiotic Prophylaxis in Ventricular Shunt Surgery: Determination of Cerebrospinal Fluid Concentration During Valve Implantation

Cefazolin Antibiotic Prophylaxis in Ventricular Shunt Surgery: Determination of Cerebrospinal Fluid(CSF) Concentration During Valve Implantation

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07067736
Acronym
CC -PIV
Enrollment
15
Registered
2025-07-16
Start date
2026-02-01
Completion date
2026-08-30
Last updated
2026-08-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Antibiotic Prophylaxis, CSF Shunts, Hydrocephaly

Keywords

Antibiotic prophylaxis, CSF shunts, Hydrocephaly

Brief summary

The objective is to determine the concentration of cefazolin in the cerebrospinal fluid after a recommended antiobiotic prophylaxis by 2g of cefazolin. Our main hypothesis is that the concentration is insufficient to protect the valve from infections. The secondary objective is to compare our results to known pharmacokinetic models of cefazolin diffusion in the literature. If differences are found we would like to search clinical features that could explain it.

Interventions

OTHERCefazolin antibiotic prophylaxis

Determination of cerebrospinal fluid concentration

Sponsors

University Hospital, Strasbourg, France
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Age \>18 years and programmed for a ventricular shunt surgery at the Hautepierre university hospital in Strasbourg.

Exclusion criteria

* Age \<18 years old * Pregnant women * Infected patients * Known cefazolin allergy * Other molecule used for the antibiotic prophylaxis * Guardianship or conservatorship * Patients under curative antibiotherapy * Non sterile pre operative CSF * Refusal to participate

Design outcomes

Primary

MeasureTime frameDescription
Cefazolin concentration in the cerebrospinal fluidThe measure is made when the dura mater is opened just before the valve implantation.Cefazolin concentration in the cerebrospinal fluid.

Secondary

MeasureTime frameDescription
blood cefazolin concentrationBlood samples are made before injectionCompare the cerebrospinal and blood cefazolin concentration to the known pharmacokinetic models in order to determine clinical features that could explain thoses differences.

Countries

France

Contacts

CONTACTBaptiste BOUCHIER, MD
baptiste.bouchier@chru-strasbourg.fr03.88.12.70.81

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 21, 2026