Serum Concentration of CEFOxitin Used for Antibiotic Prophylaxis in Obese Patients Undergoing BARiatric Surgery

NCT03306290 | Completed

• 1 other identifier: 2017-A01285-48
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Obese; Antibiotic Prophylaxis; Bariatric Surgery Candidate

Keywords

Obese; Bariatric surgery; Antibiotic prophylaxis; Cefoxitin

Outcome Measures

Primary Outcomes (1)

• Serum concentration of Cefoxitin at the beginning and end of the surgery with one extra measurement at halfway surgery

  Blood samples will be put at low temperature for transportation and then analysed by chromatographic method

  baseline

Secondary Outcomes (12)

• Identification of factors that may be associated with the risk of under-dosage

  baseline

• Identification of factors that may be associated with the risk of under-dosage

  baseline

• Identification of factors that may be associated with the risk of under-dosage

  baseline

• Identification of factors that may be associated with the risk of under-dosage

  baseline

• Pharmacokinetic parameters: drug clearance

  baseline

Study Arms (1)

Bariatric surgery candidate

OTHER

Patients included in this study belong to this arm and put up with intervention "Serum dosage of antibiotic prophylaxis CEFOXITIN"

Drug: Serum dosage of antibiotic prophylaxis CEFOXITIN

Interventions

Serum dosage of antibiotic prophylaxis CEFOXITIN DRUG

Three blood samples will be collected. These samples are specific for the research, and will be performed on the forearm opposite to the one used for Cefoxitin infusion. 1. Blood sample at the start of surgery (t0): at the end of the Cefoxitin infusion (\~30 min), 1 tube (5 ml) of blood will be withdrawn 2. Blood sample at half way surgery (t1): 1 tube (5 ml) of blood will be withdrawn (if applicable) 3. Blood sample at skin closure (t2): 1 tube (5 ml) of blood will be withdrawn

Also known as: Drug dosage

Bariatric surgery candidate

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead

Study Sites (1)

Central Hospital

Vandœuvre-lès-Nancy, 54500, France

Location

Related Publications (1)

• Novy E, Liu X, Hernandez-Mitre MP, Belveyre T, Scala-Bertola J, Roberts JA, Parker SL. Population pharmacokinetics of prophylactic cefoxitin in elective bariatric surgery patients: a prospective monocentric study. Anaesth Crit Care Pain Med. 2024 Jun;43(3):101376. doi: 10.1016/j.accpm.2024.101376. Epub 2024 Mar 15.

  PMID: 38494157 DERIVED

MeSH Terms

Conditions

Obesity

Interventions

Drug Dosage Calculations

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics

Study Officials

• El Mehdi SIAGHY

  Central Hospital, Nancy, France

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2017
• First Posted: October 11, 2017
• Study Start: October 30, 2017
• Primary Completion: June 30, 2018
• Study Completion: August 9, 2018
• Last Updated: August 28, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)