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Cefazolin Subcutaneous Microdialysis in Morbidly Obese Patients (MICK)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01309152
First Posted: March 7, 2011
Last Update Posted: January 3, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
St. Antonius Hospital
  Purpose
The investigators hypothesize that cefazolin perfusion to subcutaneous adipose tissue is reduced in morbidly obese patients. The primary objective of this exploratory pilot study is therefore to investigate target site (subcutaneous adipose tissue) penetration of cefazolin in morbidly obese patients and non-obese patients. The investigators aim to examine whether and how cefazolin plasma concentrations are predictive of subcutaneous (target) cefazolin concentrations. Possible factors of influence on the distribution of cefazolin (tissue perfusion, body weight, distribution of adipose tissue, other) will be identified.

Condition
Morbid Obesity

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Peri-and Postoperative Subcutaneous Adipose Tissue Cefazolin Determination Using Microdialysis in Morbidly Obese and Non-obese Patients

Resource links provided by NLM:


Further study details as provided by St. Antonius Hospital:

Biospecimen Retention:   Samples With DNA
serum and microdialysis filtrate of subcutenous tissue

Enrollment: 16
Study Start Date: January 2011
Study Completion Date: August 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
8 morbidly obese patients undergoing weight reducing surgery And 8 non-obese patients undergoing surgery which will require an arterial line, nadroparin and cefazolin administration perioperatively and postoperative stay at the Post-Anesthesia Care Unit.
Criteria

Inclusion Criteria:

  • Body Mass Index > 40 kg/m2
  • BMI between 20-25
  • undergoing laparoscopic gastric banding, or bypass surgery or sleeve gastrectomy (See population description for surgery type of the non-obese group)
  • 21-60 years old
  • American Society of Anaesthesiologists (ASA) physical status II to III

Exclusion Criteria:

  • pregnancy
  • breastfeeding
  • known allergy for cefazolin/nadroparin
  • known ejection fraction of < 35%
  • renal insufficiency
  Contacts and Locations
Information from the National Library of Medicine

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): NCT01309152


Locations
Netherlands
St Antonius Hospital
Nieuwegein, Utrecht, Netherlands, 2500
St Antonius Hospital
Nieuwegein, Netherlands
St. antonius hospital
Nieuwegein, Netherlands
Sponsors and Collaborators
St. Antonius Hospital
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: CAJ Knibbe, St. Antonius Hospital
ClinicalTrials.gov Identifier: NCT01309152     History of Changes
Other Study ID Numbers: MICK R-10.29A/MICK
LTME/VL-10.14/MICK
First Submitted: March 4, 2011
First Posted: March 7, 2011
Last Update Posted: January 3, 2013
Last Verified: January 2013

Keywords provided by St. Antonius Hospital:
cefazolin
microdialysis
morbid obesity
pharmacokinetics

Additional relevant MeSH terms:
Obesity, Morbid
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Cefazolin
Anti-Bacterial Agents
Anti-Infective Agents