Peri- and postoperative subcutaneous adipose tissue cefazolin determination using microdialysis in morbidly obese and non-obese patients

Peri- and postoperative subcutaneous adipose tissue cefazolin determination using microdialysis in morbidly obese and non-obese patients - MICK (Microdialysis study for the Investigation of Cefazolin Kinetics)

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON36673

Enrollment

Registered

2010-11-09

Start date

2010-12-28

Completion date

Unknown

Last updated

2024-05-06

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

Conditions

Obesitas prevention of wound infection in obese patients wound infection after surgery in obese patients

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 8 morbidly obese patients Body Mass Index > 40 kg/m2 undergoing bariatric surgery, 21-60 years old. We will stratify subjects to 4 weight groups: 100-125 kg; 125-150 kg; 150-180 kg; >180 kg. 8 non-obese adults (BMI >19

Exclusion criteria

Exclusion criteria: Pregnancy, breastfeeding, known allergy for cefazolin/nadroparin, known ejection fraction of

Design outcomes

Primary

Measure	Time frame
Primary endpoints: 1. Cefazolin concentrations in subcutaneous adipose tissue 2. Total and unbound cefazolin concentration in plasma 3. Cefazolin unbound subcutaneous tissue/unbound plasma concentration ratio differences between morbidly obese and non-obese patients	—

Secondary

Measure	Time frame
Secondary endpoints: 1. Anti-factor Xa concentrations: 11 samples in non-obese patients, 3 in morbidly obese patients) in blood following nadroparin Tertiary endpoints: 1. Pharmacokinetic parameters of cefazolin 2. Pharmacodynamic parameters of nadroparin 3. The occurrence of postoperative SSI 4. The occurrence of deep vein thrombosis /pulmonary embolism	—

Countries

Netherlands

Outcome results