Cefazolin Subcutaneous Microdialysis in Morbidly Obese Patients

Peri-and Postoperative Subcutaneous Adipose Tissue Cefazolin Determination Using Microdialysis in Morbidly Obese and Non-obese Patients

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01309152

Acronym

MICK

Enrollment

Registered

2011-03-07

Start date

2011-01-31

Completion date

2012-08-31

Last updated

2013-01-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Morbid Obesity

Keywords

cefazolin, microdialysis, morbid obesity, pharmacokinetics

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

21 Years to 60 Years

Healthy volunteers

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

Countries

Netherlands

Outcome results