Cefazolin Subcutaneous Microdialysis in Morbidly Obese Patients

Morbid Obesity Clinical Trial

— MICK  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01309152
• Other study ID #: MICK R-10.29A/MICK
• Secondary ID: LTME/VL-10.14/MI
• Status: Completed
• Phase: N/A
• First received: March 4, 2011
• Last updated: January 2, 2013
• Start date: January 2011
• Est. completion date: August 2012

Study information

• Verified date: January 2013
• Source: St. Antonius Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: August 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 60 Years

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Morbid Obesity
• Obesity, Morbid

Locations

Country	Name	City	State
Netherlands	St Antonius Hospital	Nieuwegein	Utrecht
Netherlands	St Antonius Hospital	Nieuwegein
Netherlands	St. antonius hospital	Nieuwegein

Sponsors (1)

Lead Sponsor	Collaborator
St. Antonius Hospital

Country where clinical trial is conducted

Netherlands,