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Adequacy of Perioperative Cefazolin for Surgery Antibiotic Prophylaxis in Obese Patients

NCT ID: NCT01886742

Last Updated: 2017-12-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-01

Study Completion Date

2018-10-31

Brief Summary

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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

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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

Conditions

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Obesity

Keywords

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Perioperative antibiotic prophylaxis Morbidly Obese

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Control group

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

Group Type ACTIVE_COMPARATOR

Standard Dose Group

Intervention Type DRUG

The standard dose of Cefazolin will be administered intravenously.

Treatment group

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

Group Type EXPERIMENTAL

Weight Based Group

Intervention Type DRUG

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

Interventions

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Standard Dose Group

The standard dose of Cefazolin will be administered intravenously.

Intervention Type DRUG

Weight Based Group

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Colorado, Denver

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pierre Moine, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Locations

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University of Colorado Hospital

Aurora, Colorado, United States

Site Status

Countries

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United States

Other Identifiers

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12-1653

Identifier Type: -

Identifier Source: org_study_id