Adequacy of Perioperative Cefazolin for Surgery Antibiotic Prophylaxis in Obese Patients
| Status: | Withdrawn |
|---|---|
| Conditions: | Obesity Weight Loss |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 18 - 75 |
| Updated: | 12/8/2017 |
| Start Date: | September 1, 2017 |
| End Date: | October 2018 |
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.
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.
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
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
Inclusion Criteria:
1. 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 <18 years of age or >89 Years of age
2. Pregnant women, prisoners and decisionally challenged subjects will be excluded
We found this trial at
1
site
12605 East 16th Avenue
Aurora, Colorado 80045
Aurora, Colorado 80045
720-848-0000
Principal Investigator: Pierre Moine, M.D.
University of Colorado Hospital, Site Top medical professionals, superior medicine and progressive change make University...
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