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

Phase 4

Not yet recruiting

• Conditions: heart disease; hypoalbuminemia

• Registration Number: 2024-518338-10-00
• Lead Sponsor: Medical University Of Vienna

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.

Detailed Description

Not available

Study Timeline

• Study First Posted: 2024-12-10
• Last Update Posted: 2024-12-10

Recruitment & Eligibility

• Status: Authorised, recruitment pending
• Sex: Not specified
• Target Recruitment: 20

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

Chronic severe liver disease

BMI > 35

Study & Design

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

Primary Outcome Measures

Name	Time	Method
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.		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.

Trial Locations

Locations (1)

Medical University Of Vienna; 🇦🇹 Vienna, Austria

Medical University Of Vienna

🇦🇹Vienna, Austria

Doris Hutschala-Kinstner

Site contact

+4369910117565

doris.hutschala-kinstner@meduniwien.ac.at