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Not yet recruiting NCT07067736

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

No phase Interventional Hydrocephaly CSF Shunts Antibiotic Prophylaxis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Cefazolin antibiotic prophylaxis.
Who it may be relevant to
Registry conditions: Hydrocephaly, CSF Shunts, Antibiotic Prophylaxis. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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

  • Other Cefazolin antibiotic prophylaxis
    Determination of cerebrospinal fluid concentration

Primary outcome measures

  • Cefazolin concentration in the cerebrospinal fluid [Time frame: The measure is made when the dura mater is opened just before the valve implantation.]
Secondary outcome measures (4)
  • blood cefazolin concentration [Time frame: Blood samples are made before injection]
  • blood cefazolin concentration [Time frame: Blood samples are made 30 minutes , after injection]
  • blood cefazolin concentration [Time frame: Blood samples are made 1hour after injection]
  • blood cefazolin concentration [Time frame: Blood samples are made 2 hours after injection]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Health services research

Study locations

France · 1 center
  • Hôpitaux Universitaires de Strasbourg — Strasbourg

Identifiers

NCT: NCT07067736 · 9720

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗