Clinical trial NCT01537380: Tissue and Plasma Pharmacokinetics of Cefazolin in Antibiotic Prophylaxis in Bariatric Surgery
Official title: Tissue and Plasma Pharmacokinetics of Cefazolin in Antibiotic Prophylaxis in Bariatric Surgery, an Open Label, Prospective, Single Center Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Bariatric Surgery
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2012-02-23
Enrollment: 117
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: With 6.5 million obese recorded in France in 2009, obesity is a major public health: it is a chronic disease associated with many respiratory, cardiac, metabolic, musculoskeletal complications. The risk of mortality and morbidity are directly proportional to the importance of overweight and medical treatment alone is only moderately effective weight loss. Bariatric surgery is the only treatment with proven efficacy in patients with a body mass index above 40 kg/m2. As with any surgery, there is a risk of surgical site infection (SSI). The SSI are the third most common nosocomial infection after urinary tract infections and airway. The fight against the ISO requires the administration of antibiotic prophylaxis acting on the main bacteria found in bariatric surgery. There are several studies in the literature interested in the dose of cefazolin in bariatric surgery. However, no published pharmacokinetic studies defines an optimal dose to obtain tissue and plasmatic concentrations of cefazolin higher than minimum inhibitory concentrations of the main germs encountered in these surgery. Only empirical recommendations are published, including the SFAR and the National Institute of Health in 2010. This study aims to determine whether the dose of 4 grams of cefazolin can achieve these goals of concentration and estimate an injection time of preoperative ideal for an adequate tissue concentration at the time of the incision.


Eligibility criteria: Inclusion Criteria:

* Male or female, aged \> 18 years.
* BMI ≥ 40 and ≤ 65 kg/m2.
* The patient has given informed consent in writing.

Exclusion Criteria:

* Age less than 18 years and above 70 years.
* Major Trust.
* Pregnancy.
* Moderate to severe renal insufficiency or clearance creatinine clearance \<60 ml / min
* Hypersensitivity to cephalosporins and beta-lactams.

Primary outcomes:
measure: Tissue concentration of cefazolin in the superficial subcutaneous fat during the surgical procedure
timeFrame: At the time of incision (T0), 1 hour of operation (T1), and at the closure (T2)
Secondary outcomes:
measure: Cefazolin tissue concentrations in fatty deep peri gastric tissue throughout the intervention
timeFrame: At the time of incision (T0), 1 hour of operation (T1), and at the closure (T2)
measure: Kinetics of tissue concentrations of the superficial subcutaneous fat during surgery in patients with BMI < 50 and patients with BMI > 50
timeFrame: At the time of incision (T0), 1 hour of operation (T1), and at the closure (T2)
measure: Kinetics of tissue concentrations of the deep fat peri gastric during surgery in patients with BMI < 50 and patients with BMI > 50
timeFrame: At the time of incision (T0), 1 hour of operation (T1), and at the closure (T2)
measure: Kinetics of plasma concentrations during surgery in each group
timeFrame: At the time of incision, at 15, 30, 60 minutes of operation, and at the closure
measure: Number of SSI following the surgery.
timeFrame: Within 30 days post-surgery
measure: Area Under Curve (AUC) of cefazolin plasma kinetics for each group
timeFrame: Surgical incision,15,30,60 minutes post-incision, surgical closure
Other outcomes:
Locations:
city: Nantes
country: France
facility: Nantes University Hospital
Study officials:
affiliation: Nantes Hospital
name: Romain Dumont, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cinotti R, Dumont R, Ronchi L, Roquilly A, Atthar V, Gregoire M, Planche L, Letessier E, Dailly E, Asehnoune K. Cefazolin tissue concentrations with a prophylactic dose administered before sleeve gastrectomy in obese patients: a single centre study in 116 patients. Br J Anaesth. 2018 Jun;120(6):1202-1208. doi: 10.1016/j.bja.2017.10.023. Epub 2017 Dec 6.