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

N/ANot Yet RecruitingNCT07067736

University Hospital, Strasbourg, France15 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Enrollment

Conditions

Hydrocephaly CSF Shunts Antibiotic Prophylaxis

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Cefazolin concentration in the cerebrospinal fluid

Cefazolin concentration in the cerebrospinal fluid.

Time frame: The measure is made when the dura mater is opened just before the valve implantation.

Secondary Outcomes

blood cefazolin concentration

Compare the cerebrospinal and blood cefazolin concentration to the known pharmacokinetic models in order to determine clinical features that could explain thoses differences.

Time frame: Blood samples are made before injection

blood cefazolin concentration

Compare the cerebrospinal and blood cefazolin concentration to the known pharmacokinetic models in order to determine clinical features that could explain thoses differences.

Time frame: Blood samples are made 30 minutes , after injection

blood cefazolin concentration

Compare the cerebrospinal and blood cefazolin concentration to the known pharmacokinetic models in order to determine clinical features that could explain thoses differences.

Time frame: Blood samples are made 1hour after injection

blood cefazolin concentration

Compare the cerebrospinal and blood cefazolin concentration to the known pharmacokinetic models in order to determine clinical features that could explain thoses differences.

Time frame: Blood samples are made 2 hours after injection

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts