The effect of albumin levels on blood and tissue concentrations of cefazolin in adult cardiac surgery

Phase 1

• Conditions: effect of hypoalbuminemia on pharmacokinetics of cefazolin; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2020-003174-50-AT
• Lead Sponsor: Medical University of Vienna Department of Cardiac Thoracic Vascular Anesthesia and Intensive Care Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-12-21
• Last Update Posted: 5 April 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Written informed consent
Planned use of cardiopulmonary bypass
Age: > 18 and < 90 years
Ejection fraction > 40%

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 5
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 15

Exclusion Criteria

Inability to give informed consent
Known allergy to penicillin/cephalosporins or cefazolin
Preoperative antibiotic therapy
Preoperative serum albumin concentration <40g/L
Emergency procedure
Preoperative renal failure
Chronic severe renal insufficiency including hemodialysis
Chronic severe liver disease
BMI > 35
Long standing diabetes mellitus (> 7 years) and insulin-dependent diabetes
mellitus
Pregnant women
The standardized priming solution (1500ml Ringer’s Lactate, 100ml
Mannit 20% and 10.000IE Heparin) is deemed inappropriate according to
the treating physicians

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified