Clinical trial NCT03306290: Serum Concentration of CEFOxitin Used for Antibiotic Prophylaxis in Obese Patients Undergoing BARiatric Surgery
Official title: An Evaluation of Serum Concentration of CEFOxitin Used for Antibiotic Prophylaxis in Severely and Morbidly Obese Patients Undergoing BARiatric Surgery (CEFOBAR)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obese
Antibiotic Prophylaxis
Bariatric Surgery Candidate
Keywords: Obese
Bariatric surgery
Antibiotic prophylaxis
Cefoxitin
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2017-10-11
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Obesity is a pandemic problem in modern societies. Bariatric surgery (gastric by-pass and sleeve gastrectomy) has emerged as an efficient treatment to reduce morbidity and mortality related to obesity. Obesity and bariatric surgery are known to be risk factors of surgical site infections (SSI). The occurrence of SSI increases health cost and the duration of hospitalization. However, an appropriate antibiotic prophylaxis has been shown to reduce SSI. As recommended by several national societies, the antibiotic prophylaxis dose should be increased in the severely obese population. However, this recommendation lies on a low level of evidence. Besides, great disparities regarding obese patient antibiotic prophylaxis exist between countries and adequate doses are still not clearly defined. In France, for instance, the intravenous second generation cephalosporin CEFOXITIN is used for antibiotic prophylaxis in bariatric surgery at the initial loading dose of 4g (2-fold that of non-obese population) at the beginning of surgery.

Obese patients have increased risk of under-dosage due to modification of their pharmacokinetics (fat/lean mass, distribution volume, renal clearance, etc.). Only few studies, all investigating a low amount of patients, evaluated the appropriateness of intraoperative antibiotic prophylaxis dosage of different betalactam and cephalosporin in the obese population. This population was more likely to be under-dosed.

The aim of this study is to analyse the appropriateness of the reference dose of intravenous Cefoxitin used as antibiotic prophylaxis in severely obese patients undergoing bariatric surgery. This will be a 2-year prospective monocentric study held in the University Hospital of Nancy, France. A large group of obese patients (\~300) will be included. Serial serum concentration measurements of Cefoxitin will be performed before, during, and at skin closure of the bariatric surgery. This study will give insights in pharmacokinetics of the antibiotic prophylaxis in the obese population and will help to determine the initial dosage and the optimal method for antibiotic prophylaxis administration.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years-old,
* Severely obese patient with a BMI ≥ 35 kg.m-2,
* Scheduled bariatric surgery: gastric by-pass or sleeve gastrectomy,
* Affiliated to social security,
* The patient is able to consent to clinical research and has received all information on the study design/protocol,
* Signed/written informed consent

Exclusion Criteria:

* Refuse to consent to the study or the patient is unable to consent,
* Allergy/Anaphylaxis to beta-lactam (ß-lactam) antibiotics either proven or suspected,
* Pregnancy,
* Persons deprived of their liberty by judicial or administrative decision,
* Urgent or emergent surgery.

Primary outcomes:
measure: Serum concentration of Cefoxitin at the beginning and end of the surgery with one extra measurement at halfway surgery
timeFrame: baseline
Secondary outcomes:
measure: Identification of factors that may be associated with the risk of under-dosage
timeFrame: baseline
measure: Identification of factors that may be associated with the risk of under-dosage
timeFrame: baseline
measure: Identification of factors that may be associated with the risk of under-dosage
timeFrame: baseline
measure: Identification of factors that may be associated with the risk of under-dosage
timeFrame: baseline
measure: Pharmacokinetic parameters: drug clearance
timeFrame: baseline
measure: Pharmacokinetic parameter: volume of distribution
timeFrame: baseline
measure: Pharmacokinetic parameter: half-life
timeFrame: baseline
measure: Pharmacokinetic parameter: area under curve,
timeFrame: baseline
measure: Pharmacokinetic parameter: elimination rate
timeFrame: baseline
measure: Incidence of superficial incisional surgical site infection (SSI) at 30 days
timeFrame: up to 30 days after surgery
measure: Incidence of deep incisional surgical site infection (SSI) at 30 days
timeFrame: up to 30 days after surgery
measure: Incidence of organ/space surgical site infection (SSI) at 30 days
timeFrame: up to 30 days after surgery
Other outcomes:
Locations:
city: Vandoeuvre les Nancy
country: France
facility: Central Hospital
Study officials:
affiliation: Central Hospital, Nancy, France
name: El Mehdi SIAGHY
role: STUDY_DIRECTOR
References: