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

ConditionsHydrocephalyCSF ShuntsAntibiotic Prophylaxis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Strasbourg, France

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

Age <18 years old

Pregnant women

Infected patients

Known cefazolin allergy

Trial design

Design model

Single group

Treatments tested in this trial

  • Cefazolin antibiotic prophylaxis

    Other intervention

    Determination of cerebrospinal fluid concentration

Treatment groups

15 Participants
are divided into 1 treatment group
Group A: Cefazolin antibiotic prophylaxis in ventricular shunt surgeryExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

1

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
2

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
3

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
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospital, Strasbourg, France

Lead sponsor

Source ClinicalTrials.gov
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