Preventing Systemic Inflammation After Cardiac Surgery With Alkaline Phosphatase

  • End date
    Sep 25, 2022
  • participants needed
  • sponsor
    Alloksys Life Sciences B.V.
Updated on 25 January 2021
Ruud Brands, PhD
Primary Contact
Institut Jantung Negara (IJN , Natl. Heart Inst.) (4.8 mi away) Contact
+15 other location


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.


After cardiac surgery under cardiopulmonary bypass (CPB) patients often show impairments of the immune system. Compared to placebo, CPB patients given alkaline phosphatase will have reduced composite endpoint of acute kidney injury, late extubation, gastrointestinal or neurological complications or death within 30 days.

Condition Cardiopulmonary Bypass, Systemic Inflammation, heart/lung bypass
Treatment Placebo, bRESCAP
Clinical Study IdentifierNCT03050476
SponsorAlloksys Life Sciences B.V.
Last Modified on25 January 2021


Yes No Not Sure

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
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