ObesityPhase 4NCT01886742
Adequacy of Perioperative Cefazolin for Surgery Antibiotic Prophylaxis in Obese Patients
A Phase 4 study testing Standard Dose Group and Weight Based Group in people with Obesity, run by University of Colorado, Denver at 1 site in United States.
Trial summary
The population continues to increase in weight. Currently there are no guidelines in the dosing of cefazolin for the obese population. Standard dosing of cefazolin 2 grams for patients <120 kg and 3 grams for patients >120 kg is used as the dose for surgical prophylaxis. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Obesity
- What is being tested?
- Standard Dose Group and Weight Based Group
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2017to Oct 2018
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- BMI greater than 40
- No known history of allergy to cephalosporins
- Scheduled for elective gastric bypass or laparoscopic Roux-en-y gastric bypass procedures
- Able to read and understand English
Who cannot join
- Patients <18 years of age or >89 Years of age
- Pregnant women, prisoners and decisionally challenged subjects will be excluded
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Hospital
Aurora, Colorado, 80045
About this study
The population continues to increase in weight. Currently there are no guidelines in the dosing of cefazolin for the obese population. Standard dosing of cefazolin 2 grams for patients <120 kg and 3 grams for patients >120 kg is used as the dose for surgical prophylaxis. This makes no provisions for weight based dosing. There has been some recent data which states this might not be enough for the obese patients. The primary objective of this study is to determine if weight based dosing (30 mg/kg) of cefazolin as surgical prophylaxis for patients undergoing elective gastric bypass/laparoscopic Roux-en-y gastric bypass provides appropriate serum concentrations for a larger percentage of time than the current method of giving the standard 2 or 3 gram doses of cefazolin peri-operatively. The concentration of cefazolin in tissue will also be measured to help assess this question.
Read the detailed description
The hypothesis of this study is that customary doses of antibiotics, when administered for perioperative surgical prophylaxis, are insufficient to achieve adequate antibiotic concentrations in blood and tissues of morbidly obese patients (defined as a BMI greater than 40 kg/m2) and that these patients are therefore placed at high risk of surgical wound infections and poor clinical outcomes. Cefazolin is a first-generation cephalosporin commonly used for perioperative surgical prophylaxis in colorectal, abdominal, bariatric, gynecologic and obstetric, or orthopedic total joint arthroplasty surgical procedures. Previous cefazolin pharmacokinetic (PK) analysis in obese patients led to conflicting results and recommendations. It is not clearly know to what extent the pharmacokinetics of cefazolin in morbidly obese patients differ from those of non-obese patients. Specific dosing guidelines are then lacking. The main objective of this study is to assess the pharmacokinetics of cefazolin in morbidly obese after administrations of a standard recommended 2-3 g dose or a weight-base 30-mg/kg dose
- Conditions
- Obesity
- Being tested
- Standard Dose Group, Weight Based Group
- Keywords
- Perioperative antibiotic prophylaxis, Morbidly Obese
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Dose GroupDrug
The standard dose of Cefazolin will be administered intravenously.
Weight Based GroupDrug
The weight-based dose group will receive 30 mg/kg cefazolin dose intravenously.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | Standard dose group (2 g intravenous (IV) cefazolin dose for patients <120 kg, and 3 g IV cefazolin for patients >120 kg) Receives: Drug: Standard Dose Group |
| Treatment group | Experimental | Weight-based dose group (30 mg/kg cefazolin IV) Receives: Drug: Weight Based Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of the Pharmacokinetics of Cefazolin in the Morbidly Obese
Since the goal of perioperative antimicrobial prophylaxis is to achieve free (unbound) serum and tissue drug levels that exceed the MIC for likely pathogens across the duration of the surgical procedure, and since redosing of cefazolin is recommended every 3-4 hours, PK/PD performance of cefazolin over that time frame will be analyzed. For the purposes of this study, pharmacodynamic targets are defined as fT>MIC (time during which free drug concentrations exceed pathogen MICs) of 100% over periods of up to 4 hours in duration. The PK/PD probability of target attainment (PTA) for pharmacodynamic goals and the cumulative fraction of response (CFR) for both cefazolin regimens will be compared. A PTA of ≥90% and a CFR of ≥ 90% for a dosage regimen (i.e., predicted to meet pharmacodynamic targets in ≥ 90% of the total bacterial population across the full range of MICs) are considered optimum.
Measured: Before cefazolin admin., then at 10, 30, 60, 120, 180 minutes after injection and at wound closure.
Secondary outcomes (4)
Incidence of surgical site infection
The incidence of surgical site infection will be monitored and compared.
Measured: Within 1 month postoperatively
Hospital length of stay
The length of time the subject is hospitalized will be monitored and compared.
Measured: Hospital discharge
Hospital readmission
Hospital readmission within 1 month postoperatively.
Measured: Witihn 1 month after hospital discharge
Incidence of adverse outcomes
Adverse outcomes in these patients will be monitored and compared.
Measured: Within 1 month postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2013 (estimated)
- Study start1 Sep 2017 (estimated)
- Primary completionOct 2018 (estimated)
- Study completionOct 2018 (estimated)
Why it stopped: Lack of funding
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.
- More trials run by University of Colorado, DenverThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pierre Moine, M.D., Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01886742
- Sponsor's protocol ID
- 12-1653
- Status last verified
- Dec 2017
- First submitted
- 28 Feb 2013
- Last updated
- 6 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adequacy of Perioperative Cefazolin for Surgery Antibiotic Prophylaxis in Obese Patients
- ClinicalTrials.gov ID
- NCT01886742
- Acronym / sponsor ID
- 12-1653
- Conditions
- Obesity
- Keywords
- Perioperative antibiotic prophylaxis, Morbidly Obese
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lack of funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- 1 Sep 2017 (estimated)
- Primary completion
- Oct 2018 (estimated)
- Study completion
- Oct 2018 (estimated)
- First posted
- 26 Jun 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.
The population continues to increase in weight. Currently there are no guidelines in the dosing of cefazolin for the obese population. Standard dosing of cefazolin 2 grams for patients <120 kg and 3 grams for patients >120 kg is used as the dose for surgical prophylaxis. This makes no provisions for weight based dosing. There has been some recent data which states this might not be enough for the obese patients. The primary objective of this study is to determine if weight based dosing (30 mg/kg) of cefazolin as surgical prophylaxis for patients undergoing elective gastric bypass/laparoscopic Roux-en-y gastric bypass provides appropriate serum concentrations for a larger percentage of time than the current method of giving the standard 2 or 3 gram doses of cefazolin peri-operatively. The concentration of cefazolin in tissue will also be measured to help assess this question.
Detailed description
The hypothesis of this study is that customary doses of antibiotics, when administered for perioperative surgical prophylaxis, are insufficient to achieve adequate antibiotic concentrations in blood and tissues of morbidly obese patients (defined as a BMI greater than 40 kg/m2) and that these patients are therefore placed at high risk of surgical wound infections and poor clinical outcomes. Cefazolin is a first-generation cephalosporin commonly used for perioperative surgical prophylaxis in colorectal, abdominal, bariatric, gynecologic and obstetric, or orthopedic total joint arthroplasty surgical procedures. Previous cefazolin pharmacokinetic (PK) analysis in obese patients led to conflicting results and recommendations. It is not clearly know to what extent the pharmacokinetics of cefazolin in morbidly obese patients differ from those of non-obese patients. Specific dosing guidelines are then lacking. The main objective of this study is to assess the pharmacokinetics of cefazolin in morbidly obese after administrations of a standard recommended 2-3 g dose or a weight-base 30-mg/kg dose
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Drug: Standard Dose GroupStandard dose group (2 g intravenous (IV) cefazolin dose for patients <120 kg, and 3 g IV cefazolin for patients >120 kg) |
| Treatment group | Experimental | Drug: Weight Based GroupWeight-based dose group (30 mg/kg cefazolin IV) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- BMI greater than 40
- No known history of allergy to cephalosporins
- Scheduled for elective gastric bypass or laparoscopic Roux-en-y gastric bypass procedures
- Able to read and understand English
Key exclusion criteria (2 listed)
- Patients <18 years of age or >89 Years of age
- Pregnant women, prisoners and decisionally challenged subjects will be excluded
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 |
|---|---|---|
| Standard Dose GroupThe standard dose of Cefazolin will be administered intravenously. | Drug | Control group |
| Weight Based GroupThe weight-based dose group will receive 30 mg/kg cefazolin dose intravenously. | Drug | Treatment group |
Primary outcome
Assessment of the Pharmacokinetics of Cefazolin in the Morbidly Obese
Time frame: Before cefazolin admin., then at 10, 30, 60, 120, 180 minutes after injection and at wound closure.
Since the goal of perioperative antimicrobial prophylaxis is to achieve free (unbound) serum and tissue drug levels that exceed the MIC for likely pathogens across the duration of the surgical procedure, and since redosing of cefazolin is recommended every 3-4 hours, PK/PD performance of cefazolin over that time frame will be analyzed. For the purposes of this study, pharmacodynamic targets are defined as fT>MIC (time during which free drug concentrations exceed pathogen MICs) of 100% over periods of up to 4 hours in duration. The PK/PD probability of target attainment (PTA) for pharmacodynamic goals and the cumulative fraction of response (CFR) for both cefazolin regimens will be compared. A PTA of ≥90% and a CFR of ≥ 90% for a dosage regimen (i.e., predicted to meet pharmacodynamic targets in ≥ 90% of the total bacterial population across the full range of MICs) are considered optimum.
4 secondary outcomes
Incidence of surgical site infection
Time frame: Within 1 month postoperatively
Hospital length of stay
Time frame: Hospital discharge
Hospital readmission
Time frame: Witihn 1 month after hospital discharge
Incidence of adverse outcomes
Time frame: Within 1 month postoperatively
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2017.
- Individual participant dataSharing planned: No
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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.
Pierre Moine, M.D. principal investigator
University of Colorado, Denver
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 Standard Dose Group and Weight Based Group in people with Obesity, run by University of Colorado, Denver at 1 site in United States.
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 4 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: withdrawn, as of the sponsor's last update on 6 Dec 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 United States. 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 was withdrawn before enrolling participants, so there are no results.
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?
Assessment of the Pharmacokinetics of Cefazolin in the Morbidly Obese (time frame: Before cefazolin admin., then at 10, 30, 60, 120, 180 minutes after injection and at wound closure.). 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 6 Dec 2017.