Obesity and Antibiotic Tissue Concentration
|ClinicalTrials.gov Identifier: NCT00980486|
Recruitment Status : Completed
First Posted : September 21, 2009
Last Update Posted : October 8, 2010
|Condition or disease|
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.
|Study Type :||Observational|
|Actual Enrollment :||31 participants|
|Official Title:||Effects of Maternal Obesity on Tissue Concentrations of Prophylactic Antibiotics During Cesarean Delivery|
|Study Start Date :||June 2009|
|Actual Primary Completion Date :||June 2010|
|Actual Study Completion Date :||June 2010|
- 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 ]
- 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 ]
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00980486
|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|
|Principal Investigator:||Kenneth Chan, MD||Long Beach Memorial Medical Center|