ObesityPhase 4NCT01845363
Antibiotic Prophylaxis in Bariatric Surgery With Cefazolin: Concentration in Adipose Tissue
A Phase 4 study testing Cefazolin used in antimicrobial prophylaxis in people with Obesity, run by Universidade Federal de Pernambuco at 1 site in Brazil.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Obesity
- What is being tested?
- Cefazolin used in antimicrobial prophylaxis
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteBrazil
- Study dates
- Jun 2011to May 2012
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- body mass index greater than 35 and less than 50kg/m2
Who cannot join
- Hypotension during surgery with use of vasoactive drugs
- renal disfunction (creatinine >1.5 mg/dL)
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Universidade Federal de Pernambuco - Hospital das Clínicas
Recife, Pernambuco, 50670901
About this study
Official title: 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).
- Conditions
- Obesity
- Being tested
- Cefazolin used in antimicrobial prophylaxis
- Keywords
- Obesity, Bariatric surgery, Cefazolin, antimicrobial prophylaxis, administration and dosage
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cefazolin used in antimicrobial prophylaxisDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Cefazolin | Other | 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). Receives: Drug: Cefazolin used in antimicrobial prophylaxis |
What is being measured
The primary outcome is the main question the study is designed to answer.
dosage of Cefazolin in adipose tissue during bariatric surgery
Measured: eight months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2013 (estimated)
- Study startJun 2011
- Primary completionOct 2011
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal de Pernambuco
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rafael Anlicoara, Universidade Federal de Pernambuco
- Investigators
- Rafael Anlicoara, MD, Principal investigator, UFPEAlvaro AB Ferraz, PhD, Study chair, UFPE - Hospital das ClínicasJosé L de Lima Filho, PhD, Study director, Laboratory of Immunopathology Keiso Asami(LIKA) - UFPE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01845363
- Sponsor's protocol ID
- Cefa01
- Status last verified
- Apr 2013
- First submitted
- 29 Apr 2013
- Last updated
- 3 May 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antibiotic Prophylaxis in Bariatric Surgery With Continuous Infusion of Cefazolin: Determination of Concentration in Adipose Tissue
- ClinicalTrials.gov ID
- NCT01845363
- Acronym / sponsor ID
- Cefa01
- Conditions
- Obesity
- Keywords
- Obesity, Bariatric surgery, Cefazolin, antimicrobial prophylaxis, administration and dosage
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Universidade Federal de PernambucoUniversity, hospital or other
- Study start
- Jun 2011
- Primary completion
- Oct 2011 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 3 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cefazolin | Other | Drug: Cefazolin used in antimicrobial prophylaxisCefazolin 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). |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- body mass index greater than 35 and less than 50kg/m2
Key exclusion criteria (2 listed)
- Hypotension during surgery with use of vasoactive drugs
- renal disfunction (creatinine >1.5 mg/dL)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cefazolin used in antimicrobial prophylaxisCefazolin 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. | Drug | Cefazolin |
Primary outcome
dosage of Cefazolin in adipose tissue during bariatric surgery
Time frame: eight months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rafael Anlicoara, MD principal investigator
UFPE
Alvaro AB Ferraz, PhD study chair
UFPE - Hospital das Clínicas
José L de Lima Filho, PhD study director
Laboratory of Immunopathology Keiso Asami(LIKA) - UFPE
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Cefazolin used in antimicrobial prophylaxis in people with Obesity, run by Universidade Federal de Pernambuco at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
dosage of Cefazolin in adipose tissue during bariatric surgery (time frame: eight months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2013.