Preventing Systemic Inflammation After Cardiac Surgery With Alkaline Phosphatase

• Status: Recruiting
• Trial end date: 2022-09-01
• Target enrollment: 0
• Participant gender: All

Summary

Study should demonstrate that alkaline phosphatase reduces the incidence and extent of acute kidney injury after cardiopulmonary bypass (CPB) as defined by the AKIN criteria.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Alloksys Life Sciences B.V.
• Collaborator: Aix Scientifics

Criteria

Inclusion Criteria:

• Undergoing cardiac surgery with planned cardiopulmonary bypass

• Additive Euroscore II ≥ 3 OR at least 3 surgical cardiac interventions are planned

• Ability to provide informed consent (not incapacitated)

Exclusion Criteria:

• Already on renal replacement therapy

• Patients with chronic kidney disease defined as estimated glomerular filtration rate [eGFR] < 30 mL/min/1.73 m2 [ CKD stage > 3 ]

• Patients who are pregnant

• Concurrent enrollment in another clinical trial

• Known allergic reaction to bovine alkaline phosphatase or patient is vegetarian or vegan

• Patients with ongoing infections or current use of steroids