Increased Cefazolin During Cesarean Delivery in Obese Population
| Status: | Completed |
|---|---|
| Conditions: | Obesity Weight Loss, Infectious Disease, Women's Studies |
| Therapuetic Areas: | Endocrinology, Immunology / Infectious Diseases, Reproductive |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 2/7/2015 |
| Start Date: | August 2013 |
| End Date: | June 2015 |
| Contact: | Morgan Swank, MD |
| Email: | mswank@uci.edu |
| Phone: | 714-456-2217 |
Increased Cefazolin (Ancef) Dosing for Prophylaxis During Cesarean Delivery in the Obese Population
The purpose of this study is to determine whether an increased prophylactic dose (3 grams)
of cefazolin at the time of cesarean delivery has superior coverage in adipose tissue than
the current established dosing of 2 grams. The tissue and serum concentration values, when
using an increased prophylactic dose, can then be compared to our pilot study assays in
hopes of determining an optimal dosing for the obese and morbidly obese populations
undergoing cesarean delivery.
A previous study performed at University of California, Irvine (UCI) and Long Beach Memorial
Medical Center/Miller Children's Hospital (LBMMC) showed that the standard dose of
antibiotics (2 grams of cefazolin) did not provide adequate coverage for all organisms in
the obese and extremely obese populations. The purpose of this research study is to evaluate
whether in increased dose of antibiotics given before cesarean delivery (3 grams of
cefazolin) will reach adequate levels in adipose (fat cells underneath the skin) and serum
(blood) samples. In addition, researchers hope to evaluate if/how the mother's weight has an
effect on the levels of antibiotics in the tissues (a group of similar cells).
This follow up study (prior study HS# 2009-7015 at UCI) will enroll obese (Body Mass Index
(BMI) of 30-40) and morbidly obese (BMI >40) women to receive an increased dose of
prophylactic cefazolin at time of scheduled cesarean delivery at both UCI and LBMMC.
Researchers hope to enroll a total of 35 women overall.
of cefazolin at the time of cesarean delivery has superior coverage in adipose tissue than
the current established dosing of 2 grams. The tissue and serum concentration values, when
using an increased prophylactic dose, can then be compared to our pilot study assays in
hopes of determining an optimal dosing for the obese and morbidly obese populations
undergoing cesarean delivery.
A previous study performed at University of California, Irvine (UCI) and Long Beach Memorial
Medical Center/Miller Children's Hospital (LBMMC) showed that the standard dose of
antibiotics (2 grams of cefazolin) did not provide adequate coverage for all organisms in
the obese and extremely obese populations. The purpose of this research study is to evaluate
whether in increased dose of antibiotics given before cesarean delivery (3 grams of
cefazolin) will reach adequate levels in adipose (fat cells underneath the skin) and serum
(blood) samples. In addition, researchers hope to evaluate if/how the mother's weight has an
effect on the levels of antibiotics in the tissues (a group of similar cells).
This follow up study (prior study HS# 2009-7015 at UCI) will enroll obese (Body Mass Index
(BMI) of 30-40) and morbidly obese (BMI >40) women to receive an increased dose of
prophylactic cefazolin at time of scheduled cesarean delivery at both UCI and LBMMC.
Researchers hope to enroll a total of 35 women overall.
Study Design:
This is a follow-up to the original pilot study (HS# 2009-7015 at UCI/587-08 at LBMMC). This
study is also designed to be a prospective, non-randomized, non-blinded trial of the effects
of obesity on adequacy of antimicrobial (cefazolin) concentrations with increased doses
(from 2 grams to 3 grams) of preoperative prophylactic antibiotics within adipose tissues at
the time of cesarean delivery.
Inclusion Criteria:
• Patients at term (>37 weeks) undergoing a cesarean delivery at LBMMC and UCI.
Exclusion criteria:
- pre-gestational diabetes
- chronic hypertension
- collagen vascular disease
- renal impairment
- multiple gestation
- contraindications to cefazolin administration (known anaphylactic reaction to
penicillin's or known cephalosporin allergy)
- any exposure to cephalosporins in one week prior to cesarean section
- need for emergent cesarean delivery or diagnosis of chorioamnionitis
Study Procedure:
All patients requiring cesarean delivery under non-emergent circumstances, as determined by
their physician, will be approached for participation in study by co-investigators. They
will be approached on Labor and Delivery during their intake evaluation on the day of their
scheduled procedure. Based on published literature and preliminary power analysis we expect
that each of the 2 study groups will need 1414 subjects to demonstrate statistically
significant difference in antibiotic concentrations within adipose tissue. The two groups
will consist of:
1. OBESE GROUP (BMI 30-40)
2. MORBIDLY OBESE GROUP (BMI >40)
1. All subjects will receive cefazolin at least 30, but no more than 60 minutes prior
to skin incision.
2. At the time of cesarean delivery, the following tissue samples will be collected:
- adipose tissue immediately following skin incision (prior to incision of the
fascia) and
- adipose tissue prior to skin closure
- serum sample after skin incision but prior to completion of the operative
procedure
Approximately 2 grams of tissue sampled from each site and 5 cc of blood will be required
for analysis.
All samples will be collected by Dr. Swank, Dr. Wing or a physician who had previously been
proctored in the proper tissue collecting techniques by either of the above mentioned
investigators. Upon collection, tissue specimens will be blotted to remove residual blood
and debris, weighed, and placed in a freezer (-80`C) until analysis. Serum samples will be
drawn into red top tubes and immediately placed on wet ice. Immediately following completion
of the surgery, they will then be centrifuged for 10 minutes at 3G (3200 rpm) and placed in
a locked -80`C freezer until analysis.
Tissue and serum samples will then be sent to David P. Nicolau, PhD, FCCP, FIDSA, at the
Center for Anti-Infective Research and Development, Hartford Hospital, Hartford,
Connecticut. Samples will be batched and sent all together at the completion of study
enrollment. Dr. Swank and the study nurse will be responsible for securely packing samples
on dry ice and overnight shipping them to Dr. Nicolau. Once with Dr. Nicolau, the tissue
samples will be homogenized and analyzed to determine zones of inhibition. The Cefazolin
concentrations will be determined in the serum samples using a previously validated
high-performance liquid chromatography method. 16 Tissues and serum will be sent without
direct identifiers. Dr. Nicolau will not have access to the identity of the research
subjects providing the samples.
This is a follow-up to the original pilot study (HS# 2009-7015 at UCI/587-08 at LBMMC). This
study is also designed to be a prospective, non-randomized, non-blinded trial of the effects
of obesity on adequacy of antimicrobial (cefazolin) concentrations with increased doses
(from 2 grams to 3 grams) of preoperative prophylactic antibiotics within adipose tissues at
the time of cesarean delivery.
Inclusion Criteria:
• Patients at term (>37 weeks) undergoing a cesarean delivery at LBMMC and UCI.
Exclusion criteria:
- pre-gestational diabetes
- chronic hypertension
- collagen vascular disease
- renal impairment
- multiple gestation
- contraindications to cefazolin administration (known anaphylactic reaction to
penicillin's or known cephalosporin allergy)
- any exposure to cephalosporins in one week prior to cesarean section
- need for emergent cesarean delivery or diagnosis of chorioamnionitis
Study Procedure:
All patients requiring cesarean delivery under non-emergent circumstances, as determined by
their physician, will be approached for participation in study by co-investigators. They
will be approached on Labor and Delivery during their intake evaluation on the day of their
scheduled procedure. Based on published literature and preliminary power analysis we expect
that each of the 2 study groups will need 1414 subjects to demonstrate statistically
significant difference in antibiotic concentrations within adipose tissue. The two groups
will consist of:
1. OBESE GROUP (BMI 30-40)
2. MORBIDLY OBESE GROUP (BMI >40)
1. All subjects will receive cefazolin at least 30, but no more than 60 minutes prior
to skin incision.
2. At the time of cesarean delivery, the following tissue samples will be collected:
- adipose tissue immediately following skin incision (prior to incision of the
fascia) and
- adipose tissue prior to skin closure
- serum sample after skin incision but prior to completion of the operative
procedure
Approximately 2 grams of tissue sampled from each site and 5 cc of blood will be required
for analysis.
All samples will be collected by Dr. Swank, Dr. Wing or a physician who had previously been
proctored in the proper tissue collecting techniques by either of the above mentioned
investigators. Upon collection, tissue specimens will be blotted to remove residual blood
and debris, weighed, and placed in a freezer (-80`C) until analysis. Serum samples will be
drawn into red top tubes and immediately placed on wet ice. Immediately following completion
of the surgery, they will then be centrifuged for 10 minutes at 3G (3200 rpm) and placed in
a locked -80`C freezer until analysis.
Tissue and serum samples will then be sent to David P. Nicolau, PhD, FCCP, FIDSA, at the
Center for Anti-Infective Research and Development, Hartford Hospital, Hartford,
Connecticut. Samples will be batched and sent all together at the completion of study
enrollment. Dr. Swank and the study nurse will be responsible for securely packing samples
on dry ice and overnight shipping them to Dr. Nicolau. Once with Dr. Nicolau, the tissue
samples will be homogenized and analyzed to determine zones of inhibition. The Cefazolin
concentrations will be determined in the serum samples using a previously validated
high-performance liquid chromatography method. 16 Tissues and serum will be sent without
direct identifiers. Dr. Nicolau will not have access to the identity of the research
subjects providing the samples.
Inclusion Criteria:
- Patients at term (>37 weeks) undergoing a cesarean delivery at Women's Pavilion at
Miller Children's Hospital and University of California, Irvine.
Exclusion Criteria:
- pre-gestational diabetes
- chronic hypertension
- collagen vascular disease
- renal impairment
- multiple gestation
- contraindications to Cefazolin administration (known anaphylactic reaction to
penicillin's or known cephalosporin allergy)
- any exposure to cephalosporins in one week prior to cesarean section
- need for emergent cesarean delivery or diagnosis of chorioamnionitis
We found this trial at
2
sites
Long Beach, California 90806
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