Preventing Systemic Inflammation After Cardiac Surgery With Alkaline Phosphatase

Phase 2

Recruiting

• Conditions: Systemic Inflammation; Cardiopulmonary-bypass
• Interventions: Drug: RESCAP®; Drug: placebo

• Registration Number: NCT03050476
• Lead Sponsor: Alloksys Life Sciences B.V.

Brief 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.

Study Timeline

• Study First Submitted: 2017-01-24
• Study First Submitted QC: 2017-02-08
• Study First Posted: 2017-02-13
• Study Start: 2017-11-01
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-18
• Last Update Posted: 2024-04-19
• Primary Completion: 2025-09-30
• Study Completion: 2026-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1250

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
RESCAP®	RESCAP®	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.
Placebo	placebo	Bolus of of media on induction of anaesthesia, followed by an infusion of media over the next 24 or 96 hours.

Primary Outcome Measures

Name	Time	Method
Number of patients with acute kidney injury	90 days	AKIN criteria: Rise in serum creatinine of by 0.3 mg/dl or 26 µmol/L in 48 hours/ a percentage increase in the serum creatinine concentration of more than 50 percent or a drop in urine output to 0.5 ml/kg/hour for 6 hours
reach haemodynamic stability	7 days	Demonstrate that RESCAP® intervention reduces the time at ICU to reach haemodynamic stability

Secondary Outcome Measures

Name	Time	Method
cost-related outcome	30 days	Cost (SGD) incurred on renal replacement therapy, ICU and hospital stay
levels of a set of inflammatory markers	4 days	IL-6, IL-8, IL-10, IL-17, TNF-alpha

Trial Locations

Locations (21)

Dept. Cardiothoracic Surgery , Monash Medical Centre; 🇦🇺 Clayton, Melbourne, Australia

Division of Cardiac Surgery, Department of Surgery, LKH Medical University of Graz; 🇦🇹 Graz, Austria

MedUniWien / AKH-Wien; 🇦🇹 Wien, Austria

Department of Intensive Care, CHU Saint-Pierre, Université Libre de Bruxelles (ULB); 🇧🇪 Brussels, Belgium

Department of Intensive Care, Hôpital Universitaire de Bruxelles (HUB); 🇧🇪 Brussels, Belgium

Hospital ZOL; 🇧🇪 Genk, Belgium

Dept. of Anesthesia and Intensive Care, AZ Maria Middelares; 🇧🇪 Gent, Belgium

Jessa Ziekenhuis,Campus Virga Jesse; 🇧🇪 Hasselt, Belgium

German Heart Centre Munich, Dept.Cardio-Vascular Surgery; 🇩🇪 Munich, Bavaria, Germany

Klinik für Herzchirurgie, Universitätsklinik; 🇩🇪 Leipzig, Germany

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