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Cefazolin Subcutaneous Microdialysis in Morbidly Obese Patients (MICK)

This study has been completed.
Sponsor:
Information provided by:
St. Antonius Hospital
ClinicalTrials.gov Identifier:
NCT01309152
First received: March 4, 2011
Last updated: January 2, 2013
Last verified: January 2013
History of Changes
  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:

MedlinePlus related topics: Obesity
U.S. FDA Resources

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

Ages Eligible for Study:   21 Years to 60 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: March 4, 2011
Last Updated: January 2, 2013
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

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

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

ClinicalTrials.gov processed this record on May 22, 2013