Serum and Peritoneal Concentration in Antibiotics During the Surgical Management of Peritonitis

Study Overview
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Brief Summary
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SPAC is a pilote monocentric prospective study about peritonitis and antibiotics pharmacokinetic and pharmacodynamic. The investigators will included 50 patients during 2 years in the University Hospital of Nancy. The aim of this study is to determine if the beta-lactam dosages recommended by the guidelines for management of intra-abdominal infections (published by the Société française d'anesthésie et de réanimation (Sfar) in december 2015) permitted the achievement of adequatly serum and peritoneal concentrations in the medical and surgical management of peritonitis. The investigators will collected 3 pairs of serum and peritoneal fluid samples at 3 different times: peritoneal incision, arrival in ICU and 24 hours after admission in ICU in order to compare the concentrations and the minimal inhibitor concentration of bacteria. The hypothesis is that of a serum and peritoneal antibiotic under dosage.

Official Title
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Serum and Peritoneal Concentration in Antibiotics During the Surgical Management of Peritonitis: SPAC

Conditions
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Peritonitis, Critical Illness

Intervention / Treatment
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* Other: Dosage of serum and peritoneal of the B lactam used for antibiotic treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Minimun age limits 18 years All sex Patients with peritonitis (community or nosocomial) regardless of pathology involved Patients treated in the Universty Hospital of Vandoeuvre les Nancy (abdominal surgery unit and surgical Intensive care unit JM Picard) Exclusion Criteria: Beta lactam allergy Pregnancy Age less than 18 years No respect of recommandations for antibiotics ( molecule and dosage) Person under legal protection

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Peritonitis<br>Patient received for antibiotic treatment a B lactam according to French recommendation : type of antibiotic : cefotaxime or ceftriaxone or piperacilline/tazobactam or imipenem dose : cefotaxime 2g / cetriaxone 2g / piperacilline 4g / imipenem 1g | Other: Dosage of serum and peritoneal of the B lactam used for antibiotic treatment<br>* Dosage of serum and peritoneal of the B lactam used B lactam concerning are : CEFTRIAXONE, CEFOTAXIME, PIPERACILLINE/TAZOBACTAM, IMIPENEM<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum and peritoneal beta lactams concentrations at 3 times | Population : patients with surgical peritonitis. The concentrations are compared with the minimum inhibitory concentrations of bacteria to diagnose a sub therapeutic dosage. | 3 times : Peritoneal incision, Admission in ICU and 24 hours after admission in ICU | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Factors associated with an antibiotic under-dosage | effect of presence of septic shock on antibiotic concentration | Statistical analysis after 2 years of inclusion | 
| Factors associated with an antibiotic under-dosage | effect of volume ressucitation on antibiotic concentration | Statistical analysis after 2 years of inclusion | 
| Factors associated with an antibiotic under-dosage | effect of renal function on antibiotic concentration | Statistical analysis after 2 years of inclusion | 
| Evaluate the relationship between serum and peritoneal concentrations of beta-lactam | Determination of the antibiotic diffusion coefficient through the peritoneal membrane : difference between serum concentration and peritoneal concentration of B lactam | Statistical analysis after 2 years of inclusion | 
| Morbidity of included patients | Morbidity is assessed by the presence or absence of second peritonitis surgery during hospitalization in ICU and at most 8 days (the mean of the peritonitis stays in the ICU of the investigators in 2016 is 8 days) | Reception on the 8th postoperative day | 
| Mortality of included patients | The mortality is evaluated by the presence or absence of the death of the patient during the hospitalization in ICU and at most 8 days | Reception on the 8th postoperative day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Therapeutic drug monitoring