Preventing Systemic Inflammation After Cardiac Surgery With Alkaline Phosphatase (APPIRED-III)

Alloksys Life Sciences

Status and phase: Enrolling; Phase 3; Phase 2

Conditions: Systemic Inflammation; Cardiopulmonary-bypass

Treatments: Drug: placebo; Drug: RESCAP®

Study type: Interventional

Funder types: Industry

Identifiers

NCT03050476

NUH-ALS-2015-04

Details and patient eligibility

About

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.

Full description

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 (AKI), late extubation, gastrointestinal or neurological complications within 7 days and AKI within 90 days.

Enrollment: 1,250 estimated patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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 or lactating
• 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
• Patients with high-risk emergency surgery or with follow-up procedures already planned at admission (like e.g. TEVAR)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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1,250 participants in 2 patient groups, including a placebo group

RESCAP®

Experimental group

Description:

Bolus of 1000 IU of bovine intestinal alkaline phosphatase on induction of anaesthesia, followed by an infusion with a sum of 10,000 IU/day over the next 24 or 96 hours.

Treatment:

Drug: RESCAP®

Placebo

Placebo Comparator group

Description:

Bolus of of media on induction of anaesthesia, followed by an infusion of media over the next 24 or 96 hours.

Treatment:

Drug: placebo