Adequacy of Perioperative Cefazolin for Surgery Antibiotic Prophylaxis in Obese Patients

NCT01886742 | Withdrawn Phase 4 FDA Drug

• 1 other identifier: 12-1653
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity

Keywords

Perioperative antibiotic prophylaxis; Morbidly Obese

Outcome Measures

Primary Outcomes (1)

• Assessment of the Pharmacokinetics of Cefazolin in the Morbidly Obese

  Since the goal of perioperative antimicrobial prophylaxis is to achieve free (unbound) serum and tissue drug levels that exceed the MIC for likely pathogens across the duration of the surgical procedure, and since redosing of cefazolin is recommended every 3-4 hours, PK/PD performance of cefazolin over that time frame will be analyzed. For the purposes of this study, pharmacodynamic targets are defined as fT\>MIC (time during which free drug concentrations exceed pathogen MICs) of 100% over periods of up to 4 hours in duration. The PK/PD probability of target attainment (PTA) for pharmacodynamic goals and the cumulative fraction of response (CFR) for both cefazolin regimens will be compared. A PTA of ≥90% and a CFR of ≥ 90% for a dosage regimen (i.e., predicted to meet pharmacodynamic targets in ≥ 90% of the total bacterial population across the full range of MICs) are considered optimum.

  Before cefazolin admin., then at 10, 30, 60, 120, 180 minutes after injection and at wound closure.

Secondary Outcomes (4)

• Incidence of surgical site infection

  Within 1 month postoperatively

• Hospital length of stay

  Hospital discharge

• Hospital readmission

  Witihn 1 month after hospital discharge

• Incidence of adverse outcomes

  Within 1 month postoperatively

Study Arms (2)

Control group

ACTIVE COMPARATOR

Standard dose group (2 g intravenous (IV) cefazolin dose for patients \<120 kg, and 3 g IV cefazolin for patients \>120 kg)

Drug: Standard Dose Group

Treatment group

EXPERIMENTAL

Weight-based dose group (30 mg/kg cefazolin IV)

Drug: Weight Based Group

Interventions

Standard Dose Group DRUG

The standard dose of Cefazolin will be administered intravenously.

Control group

Weight Based Group DRUG

The weight-based dose group will receive 30 mg/kg cefazolin dose intravenously.

Treatment group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• BMI greater than 40
• No known history of allergy to cephalosporins
• Scheduled for elective gastric bypass or laparoscopic Roux-en-y gastric bypass procedures
• Able to read and understand English

You may not qualify if:

• Patients \<18 years of age or \>89 Years of age
• Pregnant women, prisoners and decisionally challenged subjects will be excluded

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

University of Colorado Hospital

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Obesity

Interventions

Population Groups

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Demography; Population Characteristics

Study Officials

• Pierre Moine, M.D.

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2013
• First Posted: June 26, 2013
• Study Start: September 1, 2017
• Primary Completion: October 1, 2018
• Study Completion: October 1, 2018
• Last Updated: December 6, 2017

Record last verified: 2017-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)