A randomized open pharmacokinetic pilot study on bIAP, an anti-inflammatory moiety, in patients undergoing coronary artery bypass grafting with cardiopulmonary bypass.
Phase 2
- Conditions
- farmacokinetic behavior of bIAP10007593
- Registration Number
- NL-OMON32994
- Lead Sponsor
- Catharina-ziekenhuis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 9
Inclusion Criteria
Patients planned for elective CABG surgery with EUROscore 2-6
Exclusion Criteria
base alkaline phosphatase levels >125 IU/L
significant hepatic disease
renal insufficiency
scheduled to receive stress doses of glucocorticoids
vegetarians or intolerant for bovine products
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Main study primary endpoint is establishment of pharmacokinetic AP profiles in<br /><br>plasma during the first 8 hours post surgery.</p><br>
- Secondary Outcome Measures
Name Time Method <p>N.a.</p><br>