Tissue and Plasma Pharmacokinetics of Cefazolin in Antibiotic Prophylaxis in Bariatric Surgery (Cefasleeve)

Tissue and Plasma Pharmacokinetics of Cefazolin in Antibiotic Prophylaxis in Bariatric Surgery, an Open Label, Prospective, Single Center Trial

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.

Study Overview

• Status: Completed
• Conditions: Bariatric Surgery
• Intervention / Treatment: Drug: Cefazoline

• Study Type: Interventional
• Enrollment (Actual): 117
• Phase: Phase 4

Contacts and Locations

Study Locations

• France
  • Nantes, France, 44093
    • Nantes University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Cefazoline	Drug: Cefazoline; Injection of CEFAZOLINE (4 grams) 30-60 min before skin incision. A second injection will performed every 4 hours during the surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Tissue concentration of cefazolin in the superficial subcutaneous fat during the surgical procedure	At the time of incision (T0), 1 hour of operation (T1), and at the closure (T2)

Secondary Outcome Measures

Outcome Measure	Time Frame
Cefazolin tissue concentrations in fatty deep peri gastric tissue throughout the intervention	At the time of incision (T0), 1 hour of operation (T1), and at the closure (T2)
Kinetics of tissue concentrations of the superficial subcutaneous fat during surgery in patients with BMI < 50 and patients with BMI > 50	At the time of incision (T0), 1 hour of operation (T1), and at the closure (T2)
Kinetics of tissue concentrations of the deep fat peri gastric during surgery in patients with BMI < 50 and patients with BMI > 50	At the time of incision (T0), 1 hour of operation (T1), and at the closure (T2)
Kinetics of plasma concentrations during surgery in each group	At the time of incision, at 15, 30, 60 minutes of operation, and at the closure
Number of SSI following the surgery.	Within 30 days post-surgery
Area Under Curve (AUC) of cefazolin plasma kinetics for each group	Surgical incision,15,30,60 minutes post-incision, surgical closure

Collaborators and Investigators

• Sponsor: Nantes University Hospital
• Investigators: Principal Investigator: Romain Dumont, MD, Nantes Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: March 1, 2012
• Primary Completion (ACTUAL): April 1, 2015
• Study Completion (ACTUAL): April 1, 2015

Study Registration Dates

• First Submitted: February 17, 2012
• First Submitted That Met QC Criteria: February 17, 2012
• First Posted (ESTIMATE): February 23, 2012

Study Record Updates

• Last Update Posted (ACTUAL): July 19, 2017
• Last Update Submitted That Met QC Criteria: July 18, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Anti-Infective Agents; Anti-Bacterial Agents; Cefazolin
• Other Study ID Numbers: BRD/11/06-R