Preventing Systemic Inflammation After Cardiac Surgery With Alkaline Phosphatase

NCT03050476 | Recruiting Phase 2 DMC

• 1 other identifier: NUH-ALS-2015-04
• Study Type: interventional
• Target: 1,250
• Locations: 10 countries
• Sites: 19

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.

Conditions

Systemic Inflammation; Cardiopulmonary-bypass

Keywords

side-effects; heart-lung machine; alkaline phosphatase

Outcome Measures

Primary Outcomes (2)

• Number of patients with acute kidney injury

  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

  90 days

• reach haemodynamic stability

  Demonstrate that RESCAP® intervention reduces the time at ICU to reach haemodynamic stability

  7 days

Secondary Outcomes (2)

• cost-related outcome

  30 days

• levels of a set of inflammatory markers

  4 days

Study Arms (2)

RESCAP®

EXPERIMENTAL

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.

Drug: RESCAP®

Placebo

PLACEBO COMPARATOR

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

Drug: placebo

Interventions

RESCAP® DRUG

intravenous application before, during, and for 24 or 96 hours after heart surgery

RESCAP®

placebo DRUG

intravenous application before, during, and for 24 or 96 hours after heart surgery

Placebo

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Alloksys Life Sciences B.V.: lead
• Aix Scientifics: collaborator

Study Sites (21)

Dept. Cardiothoracic Surgery , Monash Medical Centre

Clayton, Melbourne, VIC 3168, Australia

TERMINATED

Division of Cardiac Surgery, Department of Surgery, LKH Medical University of Graz

Graz, 8036, Austria

NOT YET RECRUITING

MedUniWien / AKH-Wien

Vienna, 1090, Austria

RECRUITING

Department of Intensive Care, CHU Saint-Pierre, Université Libre de Bruxelles (ULB)

Brussels, 1000, Belgium

NOT YET RECRUITING

Department of Intensive Care, Hôpital Universitaire de Bruxelles (HUB)

Brussels, 1070, Belgium

NOT YET RECRUITING

Hospital ZOL

Genk, 3600, Belgium

SUSPENDED

Dept. of Anesthesia and Intensive Care, AZ Maria Middelares

Ghent, 9000, Belgium

RECRUITING

Jessa Ziekenhuis,Campus Virga Jesse

Hasselt, 3500, Belgium

RECRUITING

German Heart Centre Munich, Dept.Cardio-Vascular Surgery

Munich, Bavaria, 80636, Germany

NOT YET RECRUITING

Klinik für Herzchirurgie, Universitätsklinik

Leipzig, 04289, Germany

SUSPENDED

U.O.C. Cardiochirurgia e Trapianti di Cuore, Azienda Ospedaliera San Camillo Forlanini

Roma, 00152, Italy

NOT YET RECRUITING

Policlinico Gemelli, Institute Cardiology

Roma, 00168, Italy

NOT YET RECRUITING

Institut Jantung Negara (IJN , Natl. Heart Inst.)

Kuala Lumpur, 50400, Malaysia

TERMINATED

Dept. Cardiothoracic Surgery, Maastricht University Medical Centre

Maastricht, Limburg, 6229 HX, Netherlands

SUSPENDED

Catharina Ziekenhuis, Cathreine R&D, Heartcentre

Eindhoven, 5623 EJ, Netherlands

TERMINATED

Hospital de Santa Marta

Lisbon, 1169-024, Portugal

NOT YET RECRUITING

State Autonomous Healthcare Institution "Interregional Clinical Diagnostic Center"

Kazan', 420101, Russia

TERMINATED

Federal State Budgetary Military Educational Institution of the Higher Education

Saint Petersburg, 194044, Russia

TERMINATED

Almazov Heart Center

Saint Petersburg, 197341, Russia

TERMINATED

National University Hospital (NUH),

Singapore, 119228, Singapore

TERMINATED

Jefe de Servicio de Cirugía Cardiovascular, Hospital Universitario La Princesa

Madrid, 28006, Spain

NOT YET RECRUITING

Study Officials

• Ruud Brands, PhD

  Alloksys Life Sciences BV . President

  STUDY CHAIR

• Dominik Wiedemann, Prof.Dr.

  Universitätsklinikum St. Pölten, Austria

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ruud Brands, PhD

CONTACT

+31 647 228 395; ruud@alloksys.com

Eike G Fischer, PhD

CONTACT

+49 241 4500 358; eike@aix-scientifics.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2017
• First Posted: February 13, 2017
• Study Start: November 1, 2017
• Primary Completion: September 30, 2025
• Study Completion: March 31, 2026
• Last Updated: April 19, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

RU (3); AU (1); ES (1); DE (2); SG (1); PT (1); NL (2); IT (2); MY (1); BE (5)