An interventional study of Dosage of serum and peritoneal of the B lactam used for antibiotic treatment in Peritonitis and Critical Illness, sponsored by Central Hospital, Nancy, France. Status unknown at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-01-18.
Sponsored by Central Hospital, Nancy, France · Not applicable, Interventional, and Other
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.
167 studies on the registry are indexed under Peritonitis; 23 are open to participants now.
This study's planned enrollment of 50 is below the median of 79 across 106 interventional studies indexed under Peritonitis.
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Exclusion Criteria:
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
Dosage of serum and peritoneal of the B lactam used B lactam concerning are : CEFTRIAXONE, CEFOTAXIME, PIPERACILLINE/TAZOBACTAM, IMIPENEM
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.
Time frame: 3 times : Peritoneal incision, Admission in ICU and 24 hours after admission in ICU
Factors associated with an antibiotic under-dosage
effect of presence of septic shock on antibiotic concentration
Time frame: Statistical analysis after 2 years of inclusion
Factors associated with an antibiotic under-dosage
effect of volume ressucitation on antibiotic concentration
Time frame: Statistical analysis after 2 years of inclusion
Factors associated with an antibiotic under-dosage
effect of renal function on antibiotic concentration
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: Reception on the 8th postoperative day
This study is status unknown, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.
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