Clinical trial NCT01886742: Adequacy of Perioperative Cefazolin for Surgery Antibiotic Prophylaxis in Obese Patients
Official title: Adequacy of Perioperative Cefazolin for Surgery Antibiotic Prophylaxis in Obese Patients
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Obesity
Keywords: Perioperative antibiotic prophylaxis
Morbidly Obese
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2013-06-26
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

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 criteria: 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

Primary outcomes:
measure: Assessment of the Pharmacokinetics of Cefazolin in the Morbidly Obese
timeFrame: Before cefazolin admin., then at 10, 30, 60, 120, 180 minutes after injection and at wound closure.
Secondary outcomes:
measure: Incidence of surgical site infection
timeFrame: Within 1 month postoperatively
measure: Hospital length of stay
timeFrame: Hospital discharge
measure: Hospital readmission
timeFrame: Witihn 1 month after hospital discharge
measure: Incidence of adverse outcomes
timeFrame: Within 1 month postoperatively
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Hospital
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Pierre Moine, M.D.
role: PRINCIPAL_INVESTIGATOR
References: