Cefazolin Subcutaneous Microdialysis in Morbidly Obese Patients
MICK
Peri-and Postoperative Subcutaneous Adipose Tissue Cefazolin Determination Using Microdialysis in Morbidly Obese and Non-obese Patients
2 other identifiers
observational
16
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jan 2011
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2011
CompletedFirst Submitted
Initial submission to the registry
March 4, 2011
CompletedFirst Posted
Study publicly available on registry
March 7, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2012
CompletedJanuary 3, 2013
January 1, 2013
1.3 years
March 4, 2011
January 2, 2013
Conditions
Keywords
Eligibility Criteria
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.
You may qualify if:
- 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)
- years old
- American Society of Anaesthesiologists (ASA) physical status II to III
You may not qualify if:
- pregnancy
- breastfeeding
- known allergy for cefazolin/nadroparin
- known ejection fraction of \< 35%
- renal insufficiency
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
St Antonius Hospital
Nieuwegein, Utrecht, 2500, Netherlands
St Antonius Hospital
Nieuwegein, Netherlands
St. antonius hospital
Nieuwegein, Netherlands
Related Publications (2)
Diepstraten J, Janssen EJ, Hackeng CM, van Dongen EP, Wiezer RJ, van Ramshorst B, Knibbe CA. Population pharmacodynamic model for low molecular weight heparin nadroparin in morbidly obese and non-obese patients using anti-Xa levels as endpoint. Eur J Clin Pharmacol. 2015 Jan;71(1):25-34. doi: 10.1007/s00228-014-1760-4. Epub 2014 Oct 12.
PMID: 25304008DERIVEDBrill MJ, Houwink AP, Schmidt S, Van Dongen EP, Hazebroek EJ, van Ramshorst B, Deneer VH, Mouton JW, Knibbe CA. Reduced subcutaneous tissue distribution of cefazolin in morbidly obese versus non-obese patients determined using clinical microdialysis. J Antimicrob Chemother. 2014 Mar;69(3):715-23. doi: 10.1093/jac/dkt444. Epub 2013 Nov 8.
PMID: 24214905DERIVED
Biospecimen
serum and microdialysis filtrate of subcutenous tissue
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
March 4, 2011
First Posted
March 7, 2011
Study Start
January 1, 2011
Primary Completion
May 1, 2012
Study Completion
August 1, 2012
Last Updated
January 3, 2013
Record last verified: 2013-01