Critical Illness, Peritonitis
Conditions
Keywords
Therapeutic drug monitoring
Brief summary
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.
Interventions
OTHERDosage of serum and peritoneal of the B lactam used for antibiotic treatment
Dosage of serum and peritoneal of the B lactam used B lactam concerning are : CEFTRIAXONE, CEFOTAXIME, PIPERACILLINE/TAZOBACTAM, IMIPENEM
Sponsors
Central Hospital, Nancy, France
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Serum and peritoneal beta lactams concentrations at 3 times | 3 times : Peritoneal incision, Admission in ICU and 24 hours after admission in ICU | Population : patients with surgical peritonitis. The concentrations are compared with the minimum inhibitory concentrations of bacteria to diagnose a sub therapeutic dosage. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Factors associated with an antibiotic under-dosage | Statistical analysis after 2 years of inclusion | effect of presence of septic shock on antibiotic concentration |
| Evaluate the relationship between serum and peritoneal concentrations of beta-lactam | Statistical analysis after 2 years of inclusion | Determination of the antibiotic diffusion coefficient through the peritoneal membrane : difference between serum concentration and peritoneal concentration of B lactam |
| Morbidity of included patients | Reception on the 8th postoperative day | 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) |
| Mortality of included patients | Reception on the 8th postoperative day | 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 |
Countries
France
Contacts
Primary ContactEmmanuel NOVY, MD
Backup ContactEl Mehdi SIAGHY
Outcome results
None listed