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

Critical Illness Clinical Trial

— SPAC  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03310606
• Other study ID #: 2017-A00710-53
• Status: Recruiting
• Phase: N/A
• Start date: October 24, 2017
• Est. completion date: May 1, 2019

Study information

• Verified date: January 2019
• Source: Central Hospital, Nancy, France
• Contact: Emmanuel NOVY, MD
• Phone: +33 3157437
• Email: e.novy[@]chru-nancy.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: May 1, 2019
• Est. primary completion date: March 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Critical Illness
• Peritonitis

Intervention

Other:
• Dosage 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

Locations

Country	Name	City	State
France	Central Hospital	Vandoeuvre les Nancy

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Factors associated with an antibiotic under-dosage	effect of presence of septic shock on antibiotic concentration	Statistical analysis after 2 years of inclusion
Secondary	Factors associated with an antibiotic under-dosage	effect of volume ressucitation on antibiotic concentration	Statistical analysis after 2 years of inclusion
Secondary	Factors associated with an antibiotic under-dosage	effect of renal function on antibiotic concentration	Statistical analysis after 2 years of inclusion
Secondary	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
Secondary	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
Secondary	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