The Effect of Albumin Levels on Pharmacokinetics of Cefazolin in Adult Cardiac Surgery: A Prospective, Randomized, Open-label, Parallel-group Pharmacokinetic Study

Medical University Of Vienna1 site in 1 country20 target enrollmentDecember 10, 2024

DrugsHuman Albumin „CSL Behring“ ® 20 % Infusionslösung Kefzol 2 g – Trockensubstanz zur Infusionsbereitung

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Not specified
Sponsor: Medical University Of Vienna
Enrollment: 20
Locations: 1
Primary Endpoint: The area under the concentration-time curve from 0 - 10h (AUC0-10 ) for free + total drug will be compared between the control and intervention group.
Status: Not yet recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

Primary objective: The area under the concentration-time curve from 0 - 10h (AUC0-10 ) for free and total drug will be compared between the control and intervention group.

Registry

euclinicaltrials.eu

Start Date

December 10, 2024

End Date

TBD

Last Updated

last year

Study Type

Interventional clinical trial of medicinal product

Investigators

Sponsor

Medical University Of Vienna

Responsible Party

Principal Investigator

Division of Cardiac Thoracic Vascular Anaesthesia and Intensive Care Medicine

Scientific

Medical University Of Vienna

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

•Inability to give informed consent
•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
•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

Outcomes

Primary Outcomes

The area under the concentration-time curve from 0 - 10h (AUC0-10 ) for free + total drug will be compared between the control and intervention group.