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

Tracking Information
First Received Date ^ICMJE	March 4, 2011
Last Updated Date	January 2, 2013
Start Date ^ICMJE	January 2011
Primary Completion Date	May 2012 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE	Not Provided
Original Primary Outcome Measures ^ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT01309152 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Cefazolin Subcutaneous Microdialysis in Morbidly Obese Patients
Official Title ^ICMJE	Peri-and Postoperative Subcutaneous Adipose Tissue Cefazolin Determination Using Microdialysis in Morbidly Obese and Non-obese Patients
Brief Summary	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.
Detailed Description	Not Provided
Study Type ^ICMJE	Observational
Study Design ^ICMJE	Observational Model: Case Control Time Perspective: Prospective
Target Follow-Up Duration	Not Provided
Biospecimen	Retention: Samples With DNA Description: serum and microdialysis filtrate of subcutenous tissue
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.
Condition ^ICMJE	Morbid Obesity
Intervention ^ICMJE	Not Provided
Study Group/Cohort (s)	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	16
Completion Date	August 2012
Primary Completion Date	May 2012 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	21 Years to 60 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Netherlands

Administrative Information
NCT Number ^ICMJE	NCT01309152
Other Study ID Numbers ^ICMJE	MICK R-10.29A/MICK, LTME/VL-10.14/MICK
Has Data Monitoring Committee	No
Responsible Party	CAJ Knibbe, St. Antonius Hospital
Study Sponsor ^ICMJE	St. Antonius Hospital
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	St. Antonius Hospital
Verification Date	January 2013
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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