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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

Page last updated: August 20, 2015

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