drugset / Trial / NCT01886742

Adequacy of Perioperative Cefazolin for Surgery Antibiotic Prophylaxis in Obese Patients

NCT01886742

Phase 4 Withdrawn University of Colorado, Denver
RandomizedParallel-groupOpen-labelPrevention

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.

Timeline

Start
2017-09-01
Primary completion
2018-10
Completion
2018-10

Drugs

EvaluationDrugModalityDoseRoute
Comparator Cefazolin Small molecule 30 mg/kg Intravenous
Comparator Cefazolin Small molecule 2 g Intravenous
Comparator Cefazolin Small molecule 3 g Intravenous

Indications