Cefazolin Subcutaneous Microdialysis in Morbidly Obese Patients

NCT ID: NCT01309152

Last Updated: 2013-01-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

16 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-01-31

Study Completion Date

2012-08-31

Brief Summary

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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

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Conditions

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Morbid Obesity

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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St. Antonius Hospital

OTHER

Sponsor Role lead

Responsible Party

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St. Antonius Hospital

Locations

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St Antonius Hospital

Nieuwegein, Utrecht, Netherlands

Site Status

St Antonius Hospital

Nieuwegein, , Netherlands

Site Status

St. antonius hospital

Nieuwegein, , Netherlands

Site Status

Countries

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Netherlands

References

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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.

Reference Type DERIVED
PMID: 25304008 (View on PubMed)

Brill 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.

Reference Type DERIVED
PMID: 24214905 (View on PubMed)

Other Identifiers

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LTME/VL-10.14/MICK

Identifier Type: -

Identifier Source: secondary_id

MICK R-10.29A/MICK

Identifier Type: -

Identifier Source: org_study_id

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