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

Not Applicable

• Conditions: Critical Illness; Peritonitis

• Registration Number: NCT03310606
• Lead Sponsor: Central Hospital, Nancy, France

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-08-28
• Study First Submitted QC: 2017-10-13
• Study First Posted: 2017-10-16
• Study Start: 2017-10-24
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-17
• Last Update Posted: 2019-01-18
• Primary Completion: 2019-03-01
• Study Completion: 2019-05-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
Factors associated with an antibiotic under-dosage	Statistical analysis after 2 years of inclusion	effect of renal function on antibiotic concentration
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)
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

Trial Locations

Locations (1)

Central Hospital; 🇫🇷 Vandoeuvre les Nancy, France