Obesity and Antibiotic Tissue Concentration

This study has been completed.
Sponsor:
Collaborator:
University of California, Irvine
Information provided by:
MemorialCare
ClinicalTrials.gov Identifier:
NCT00980486
First received: September 18, 2009
Last updated: October 7, 2010
Last verified: September 2010
  Purpose

The purpose of this study is to determine whether the dose of prophylactic antibiotics at the time of cesarean delivery requires adjustment in obese and overweight patients in order to achieve optimal antimicrobial activity.


Condition
Obesity

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Effects of Maternal Obesity on Tissue Concentrations of Prophylactic Antibiotics During Cesarean Delivery

Resource links provided by NLM:


Further study details as provided by MemorialCare:

Primary Outcome Measures:
  • To assess the effects of maternal obesity on the concentrations and adequacy of antimicrobial activity of prophylactically administered antibiotics within tissues (subcutaneous adipose and myometrial) at the time of cesarean delivery. [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To assess the concentrations and adequacy of antimicrobial activity of prophylactically administered antibiotics within tissues (subcutaneous adipose and myometrial) at the time of cesarean delivery. [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Adipose, myometrial and blood serum samples


Enrollment: 31
Study Start Date: June 2009
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
BMI <30
BMI <30
BMI 30-39
BMI 30-39
BMI >40
BMI >40

Detailed Description:

The majority of information regarding pharmacokinetics and pharmacodynamics (the action, properties and elimination of a drug in the body) of antibiotics is based on measurements of the serum and plasma concentrations. Current guidelines for surgical antibiotic prophylaxis have clearly demonstrated appropriate therapeutic levels within blood and serum levels, resulting in low incidence of postoperative bacteremia (bacteria in the blood) and sepsis (infection). Despite this, surgical site infections (SSI) remain the most common postoperative complication, affecting up to 20% of patients undergoing intra-abdominal surgery. Inadequate antibiotic penetration into the tissues of the surgical site, in spite of therapeutic serum levels, results in an environment that is susceptible to pathogens and subsequent infections. Antimicrobial tissue levels are influenced by volume of distribution, regional blood flow and biological properties of tissue. The ability of any drug to reach the tissue of interest is dictated by the relative amount of blood flow to that organ. While lungs and kidneys enjoy a robust blood supply, subcutaneous adipose tissue (fat) (the most frequent site of surgical site infections) receives a small fraction of the cardiac output. Obesity creates an increased volume of distribution, thereby resulting in a greater dilution of antibiotics when compared to non-obese subjects. Moreover, this change in volume of distribution is achieved primarily by increasing the relative amount of poorly perfused adipose tissue. Therefore, it should come as no surprise that obesity is a significant risk factor for surgical site infections.

The rate of obesity in the United States has shown a steady increase and more than doubled in the last twenty-five years from 15% in 1980 to 32.9% in 2004. Moreover, nearly one third of women of reproductive age are obese and approximately 6% are extremely obese. In addition to the usual health related concerns, obesity significantly increases the rate of complications associated with pregnancy. In particular, several studies have demonstrated an increased incidence of cesarean delivery associated to maternal obesity. Cesarean delivery rates, much like obesity rates, have witnessed a tremendous surge in the last few decades and now account for approximately 30% of all deliveries or nearly 1.2 million procedures. Surgical site infections associated with cesarean delivery include wound infections and endomyometritis (infection in the uterus), with rates ranging from 7% to 20% depending on the demographic and obstetric variables. Despite these alarming trends there is a paucity of data regarding antimicrobial activity of prophylactic antibiotics in tissues and the effects of maternal obesity on these concentrations at the time of cesarean delivery.

While the rates of cesarean deliveries have reached a plateau at around 30% in recent years, the rates of obesity continue to climb unabated. As the attributes of the population evolve over the course of time so must the guidelines and management adapt to the individuals in our care.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

All patients requiring cesarean delivery under non-emergent circumstances

Criteria

Inclusion Criteria:

  • Patients at term (> 37 weeks) undergoing a cesarean delivery.

Exclusion Criteria:

  • Women younger than 18 years,
  • Pre-gestational diabetes,
  • Chronic hypertension,
  • Collagen vascular disease,
  • Multiple gestation,
  • Contraindications to cefazolin administration (known anaphylactic reaction to penicillins or known cephalosporin allergy),
  • Any exposure to cephalosporins in one week prior to cesarean section, OR
  • Need for emergent cesarean delivery or diagnosis of chorioamnionitis.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00980486

Locations
United States, California
Women's Pavilion at Miller Children's Hospital
Long Beach, California, United States, 90806
University of California Irvine Medical Center
Orange, California, United States, 92868
Sponsors and Collaborators
MemorialCare
University of California, Irvine
Investigators
Principal Investigator: Kenneth Chan, MD Long Beach Memorial Medical Center
  More Information

No publications provided by MemorialCare

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Kenneth Chan MD, Long Beach Memorial Medical Center
ClinicalTrials.gov Identifier: NCT00980486     History of Changes
Other Study ID Numbers: 587-08
Study First Received: September 18, 2009
Last Updated: October 7, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by MemorialCare:
Antibiotic Concentration
Tissue
Obesity
Cesarean

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antitubercular Agents

ClinicalTrials.gov processed this record on July 26, 2014