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OpenTrials
Completed

NCT Number: NCT01309152

Cefazolin Subcutaneous Microdialysis in Morbidly Obese Patients

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.

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Key information

Conditions

Morbid Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Obesity, Morbid Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

21 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

St Antonius Hospital, Nieuwegein, Utrecht, Netherlands

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

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Sponsors and collaborators

Lead sponsor

St. Antonius Hospital

Other

Registry information

Official study title

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

Acronym: MICK

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Mar 7, 2011
Registry last updated
Jan 3, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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