Adequacy of Perioperative Cefazolin for Surgery Antibiotic Prophylaxis in Obese Patients
Information source: University of Colorado, Denver
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Obesity
Intervention: Cefazolin (Drug); Cefazolin (Drug)
Phase: Phase 4
Status: Not yet recruiting
Sponsored by: University of Colorado, Denver Official(s) and/or principal investigator(s): Pierre Moine, M.D., Principal Investigator, Affiliation: University of Colorado, Denver
Overall contact: Colleen K Dingmann, R.N., Ph.D., Phone: 303-724-7494, Email: colleen.dingmann@ucdenver.edu
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. 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.
Clinical Details
Official title: Adequacy of Perioperative Cefazolin for Surgery Antibiotic Prophylaxis in Obese Patients
Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Primary outcome: To assess the Pharmacokinetics Cefazolin in Morbidly Obese
Secondary outcome: Secondarily, the surgical site infection incidence within 1 month postoperatively, the hospital length of stay, an hospital readmission within 1 month postoperatively, or any adverse outcomes in these patients will be monitored and compared.
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
Eligibility
Minimum age: 18 Years.
Maximum age: 75 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
1. Patient must have a BMI greater than 40
2. No known history of allergy to cephalosporins
3. Scheduled for elective gastric bypass or laparoscopic Roux-en-y gastric bypass
procedures
4. Able to read and understand English
Exclusion Criteria:
1. Patients less than a BMI of 40
2. Known history of cephalosporin allergy
3. Unable to read and understand English.
4. Patients <18 years of age or >89 Years of age
5. Pregnant women, prisoners and decisionally challenged subjects will be excluded
Locations and Contacts
Colleen K Dingmann, R.N., Ph.D., Phone: 303-724-7494, Email: colleen.dingmann@ucdenver.edu
University of Colorado Hospital, Aurora, Colorado 80045, United States; Not yet recruiting Pierre Moine, M.D., Principal Investigator
Additional Information
Starting date: June 2015
Last updated: June 9, 2015
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