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The Effect of Albumin Levels on Pharmacokinetics of Cefazolin in Adult Cardiac Surgery: A Prospective, Randomized, Open-label, Parallel-group Pharmacokinetic Study
EU CTIS ID: 2024-518338-10-00
What this study is testing
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.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- written informed consent
- Planned use of cardiopulmonary bypass
- Age: > 18 and < 90 years
- Ejection fraction > 40%
You likely can't join if
- 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
See the full eligibility criteria
- written informed consent
- Planned use of cardiopulmonary bypass
- Age: > 18 and < 90 years
- Ejection fraction > 40%
- 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.