Bariatric SurgeryPhase 4CefasleeveNCT01537380
Tissue and Plasma Pharmacokinetics of Cefazolin in Antibiotic Prophylaxis in Bariatric Surgery
A Phase 4 study testing Cefazoline in people with Bariatric Surgery, run by Nantes University Hospital at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Bariatric Surgery
- What is being tested?
- Cefazoline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 117 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2012to Apr 2015
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female, aged > 18 years.
- BMI ≥ 40 and ≤ 65 kg/m2.
- The patient has given informed consent in writing.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Bariatric Surgery
- Being tested
- Cefazoline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CefazolineDrug
Injection of CEFAZOLINE (4 grams) 30-60 min before skin incision. A second injection will performed every 4 hours during the surgery
| Study group | Role | What they receive |
|---|---|---|
| Cefazoline | Experimental | Not described Receives: Drug: Cefazoline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tissue concentration of cefazolin in the superficial subcutaneous fat during the surgical procedure
Measured: At the time of incision (T0), 1 hour of operation (T1), and at the closure (T2)
Secondary outcomes (6)
Cefazolin tissue concentrations in fatty deep peri gastric tissue throughout the intervention
Measured: 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
Measured: 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
Measured: 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
Measured: At the time of incision, at 15, 30, 60 minutes of operation, and at the closure
Number of SSI following the surgery.
Measured: Within 30 days post-surgery
Area Under Curve (AUC) of cefazolin plasma kinetics for each group
Measured: Surgical incision,15,30,60 minutes post-incision, surgical closure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2012 (estimated)
- Study startMar 2012
- Primary completionApr 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bariatric SurgeryStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 117 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Romain Dumont, MD, Principal investigator, Nantes Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01537380
- Sponsor's protocol ID
- BRD/11/06-R
- Acronym
- Cefasleeve
- Status last verified
- Jul 2017
- First submitted
- 17 Feb 2012
- Last updated
- 19 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 29793587
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tissue and Plasma Pharmacokinetics of Cefazolin in Antibiotic Prophylaxis in Bariatric Surgery, an Open Label, Prospective, Single Center Trial
- ClinicalTrials.gov ID
- NCT01537380
- Acronym / sponsor ID
- Cefasleeve / BRD/11/06-R
- Conditions
- Bariatric Surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 117 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 23 Feb 2012 (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.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cefazoline | Experimental | Drug: Cefazoline |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or female, aged > 18 years.
- BMI ≥ 40 and ≤ 65 kg/m2.
- The patient has given informed consent in writing.
Key exclusion criteria (5 listed)
- 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.
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 |
|---|---|---|
| CefazolineInjection of CEFAZOLINE (4 grams) 30-60 min before skin incision. A second injection will performed every 4 hours during the surgery | Drug | Cefazoline |
Primary outcome
Tissue concentration of cefazolin in the superficial subcutaneous fat during the surgical procedure
Time frame: At the time of incision (T0), 1 hour of operation (T1), and at the closure (T2)
6 secondary outcomes
Cefazolin tissue concentrations in fatty deep peri gastric tissue throughout the intervention
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: At the time of incision, at 15, 30, 60 minutes of operation, and at the closure
Number of SSI following the surgery.
Time frame: Within 30 days post-surgery
Area Under Curve (AUC) of cefazolin plasma kinetics for each group
Time frame: Surgical incision,15,30,60 minutes post-incision, surgical closure
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 19 Jul 2017.
- Derived from this study: PubMed 29793587Cinotti 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.
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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.
Romain Dumont, MD principal investigator
Nantes Hospital
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 Cefazoline in people with Bariatric Surgery, run by Nantes University Hospital at 1 site in France.
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 3 inclusion and 5 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 19 Jul 2017. 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 France. 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?
Tissue concentration of cefazolin in the superficial subcutaneous fat during the surgical procedure (time frame: At the time of incision (T0), 1 hour of operation (T1), and at the closure (T2)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01537380, which also lists 1 linked publication.
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 19 Jul 2017.