A randomized open pharmacokinetic pilot study on bIAP, an anti-inflammatory moiety, in patients undergoing coronary artery bypass grafting with cardiopulmonary bypass.

A randomized open pharmacokinetic pilot study on bIAP, an anti-inflammatory moiety, in patients undergoing coronary artery bypass grafting with cardiopulmonary bypass. - Pilot APPIRED II study

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON32994

Enrollment

Registered

2009-04-02

Start date

2009-03-15

Completion date

Unknown

Last updated

2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

farmacokinetic behavior of bIAP

Interventions

Patients receive either bIAP (alkaline phosphatase, 1000 IU) just prior to surgery as a bolus (n=3) or receive a bolus bIAP (1000 IU) followed by a 40 IU/kg bIAP infusion during the first 8 hours po

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Patients planned for elective CABG surgery with EUROscore 2-6

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Main study primary endpoint is establishment of pharmacokinetic AP profiles in plasma during the first 8 hours post surgery.	—

Secondary

Measure	Time frame
N.a.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)