Pharmacokinetics of Cefuroxim (CXM) and tranexamic acid (TXA) in children less than one year of age undergoing pediatric cardiac surgery.

• Conditions: antibiotic concentrations (cefuroxime)antifibriniolytics (tranexamic acid); D68.9; Coagulation defect, unspecified

• Registration Number: DRKS00004538
• Lead Sponsor: Deutsches Herzzentrum München

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01-04
• Study Completion: 2015-12-31
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 43

Inclusion Criteria

Pediatric cardiac patients less than one year of age undergoing cardiac surgery with and without cardiopulmonary bypass.

Exclusion Criteria

Participation in any interventional study. Pretreatment with antibiotics and tranexamic acid.

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Chromatographic determination of serum concentrations of cefuroxime and tranexamic acid with and without the use of cardiopulmonary bypass.

Secondary Outcome Measures

Name	Time	Method
Determination of elimination half life, Clearance, AUC, maximaler Serumkonzentration Cmax and mean residence time (MRT) for both substances.