- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01845363
Antibiotic Prophylaxis in Bariatric Surgery With Cefazolin: Concentration in Adipose Tissue
Antibiotic Prophylaxis in Bariatric Surgery With Continuous Infusion of Cefazolin: Determination of Concentration in Adipose Tissue
Eighteen patients were given a dose of 2g Cefazolin in anesthetic induction, supplemented with 1g delivered through continuous infusion during surgery. Adipose samples, obtained at the beginning and end of surgery, were analyzed using high performance liquid chromatography.
Some published studies suggest that the dose of 2g does not supply the minimum inhibitory concentration for principal causal agents of surgical site infection.
To determine the concentration of Cefazolin in adipose tissue of patients undergoing bariatric surgery and to evaluate the relationship between concentrations obtained and body mass index (BMI).
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
Pernambuco
-
Recife, Pernambuco, Brazil, 50670901
- Universidade Federal de Pernambuco - Hospital das Clínicas
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- body mass index greater than 35 and less than 50kg/m2
Exclusion Criteria:
- Hypotension during surgery with use of vasoactive drugs
- renal disfunction (creatinine >1.5 mg/dL)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Cefazolin
Cefazolin used in antimicrobial prophylaxis Cefazolin administered a first dose of 2g in anesthetic induction, followed by continuous dosage of 1g diluted in 250mL of saline solution for two hours. Two samples of subcutaneous tissue were collected for analysis: the first soon after the incision, and a second before skin synthesis. The samples were processed by High Pressure Liquid Chromatography (HPLC). |
Cefazolin administered a first dose of 2g in anesthetic induction, followed by continuous dosage of 1g diluted in 250mL of saline solution for two hours. Two samples of subcutaneous tissue were collected for analysis: the first soon after the incision, and a second before skin synthesis. The samples were processed by HPLC. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
dosage of Cefazolin in adipose tissue during bariatric surgery
Time Frame: eight months
|
eight months
|
Collaborators and Investigators
Investigators
- Principal Investigator: Rafael Anlicoara, MD, UFPE
- Study Chair: Alvaro AB Ferraz, PhD, UFPE - Hospital das Clínicas
- Study Director: José L de Lima Filho, PhD, Laboratory of Immunopathology Keiso Asami(LIKA) - UFPE
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Cefa01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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