NCT03050476

Preventing Systemic Inflammation After Cardiac Surgery With Alkaline Phosphatase

Preventing Oxidative Stress-induced Ischemic Injury- and Systemic Inflammation Complications During and After Invasive Cardiac Surgery With Alkaline Phosphatase (APPIRED III)

• Status: Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 1,250 (estimated)
• Sponsor: Alloksys Life Sciences B.V. · Industry
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Systemic Inflammation
• Cardiopulmonary-bypass

Interventions

Type	Name	Description
DRUG	RESCAP®	intravenous application before, during, and for 24 or 96 hours after heart surgery
DRUG	placebo	intravenous application before, during, and for 24 or 96 hours after heart surgery

Timeline

• Start date: 2017-11-01
• Primary completion: 2025-09-30
• Completion: 2026-03-31
• First posted: 2017-02-13
• Last updated: 2024-04-19

Locations

21 sites across 11 countries: Australia, Austria, Belgium, Germany, Italy, Malaysia, Netherlands, Portugal, Russia, Singapore, Spain