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

April 18, 2024 updated by: Alloksys Life Sciences B.V.

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

1250

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Australia
    • Melbourne
      • Clayton, Melbourne, Australia, VIC 3168
        • Terminated
        • Dept. Cardiothoracic Surgery , Monash Medical Centre
  • Austria
  • Belgium
      • Brussels, Belgium, 1000
        • Not yet recruiting
        • Department of Intensive Care, CHU Saint-Pierre, Université Libre de Bruxelles (ULB)
        • Contact:
      • Brussels, Belgium, 1070
        • Not yet recruiting
        • Department of Intensive Care, Hôpital Universitaire de Bruxelles (HUB)
        • Contact:
      • Genk, Belgium, 3600
        • Suspended
        • Hospital ZOL
      • Gent, Belgium, 9000
        • Recruiting
        • Dept. of Anesthesia and Intensive Care, AZ Maria Middelares
        • Contact:
      • Hasselt, Belgium, 3500
        • Recruiting
        • Jessa Ziekenhuis,Campus Virga Jesse
        • Contact:
  • Germany
      • Leipzig, Germany, 04289
        • Suspended
        • Klinik für Herzchirurgie, Universitätsklinik
    • Bavaria
      • Munich, Bavaria, Germany, 80636
        • Not yet recruiting
        • German Heart Centre Munich, Dept.Cardio-Vascular Surgery
        • Contact:
  • Italy
      • Roma, Italy, 00168
        • Not yet recruiting
        • Policlinico Gemelli, Institute Cardiology
        • Contact:
      • Roma, Italy, 00152
        • Not yet recruiting
        • U.O.C. Cardiochirurgia e Trapianti di Cuore, Azienda Ospedaliera San Camillo Forlanini
        • Contact:
  • Malaysia
      • Kuala Lumpur, Malaysia, 50400
        • Terminated
        • Institut Jantung Negara (IJN , Natl. Heart Inst.)
  • Netherlands
      • Eindhoven, Netherlands, 5623 EJ
        • Terminated
        • Catharina Ziekenhuis, Cathreine R&D, Heartcentre
    • Limburg
      • Maastricht, Limburg, Netherlands, 6229 HX
        • Suspended
        • Dept. Cardiothoracic Surgery, Maastricht University Medical Centre
  • Portugal
  • Russian Federation
      • Kazan, Russian Federation, 420101
        • Terminated
        • State Autonomous Healthcare Institution "Interregional Clinical Diagnostic Center"
      • Saint Petersburg, Russian Federation, 194044
        • Terminated
        • Federal State Budgetary Military Educational Institution of the Higher Education
      • St Petersburg, Russian Federation, 197341
        • Terminated
        • Almazov Heart Center
  • Singapore
      • Singapore, Singapore, 119228
        • Terminated
        • National University Hospital (NUH),
  • Spain
      • Madrid, Spain, 28006
        • Not yet recruiting
        • Jefe de Servicio de Cirugía Cardiovascular, Hospital Universitario La Princesa
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Drug: RESCAP®
intravenous application before, during, and for 24 or 96 hours after heart surgery
Placebo Comparator: Placebo
Bolus of of media on induction of anaesthesia, followed by an infusion of media over the next 24 or 96 hours.
Drug: placebo
intravenous application before, during, and for 24 or 96 hours after heart surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients with acute kidney injury
Time Frame: 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
90 days
reach haemodynamic stability
Time Frame: 7 days
Demonstrate that RESCAP® intervention reduces the time at ICU to reach haemodynamic stability
7 days

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alloksys Life Sciences B.V.

Collaborators

Aix Scientifics

Investigators

  • Study Chair: Ruud Brands, PhD, Alloksys Life Sciences BV . President
  • Principal Investigator: Dominik Wiedemann, Prof.Dr., Universitätsklinikum St. Pölten, Austria

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2017

Primary Completion (Estimated)

September 30, 2025

Study Completion (Estimated)

March 31, 2026

Study Registration Dates

First Submitted

January 24, 2017

First Submitted That Met QC Criteria

February 8, 2017

First Posted (Actual)

February 13, 2017

Study Record Updates

Last Update Posted (Actual)

April 19, 2024

Last Update Submitted That Met QC Criteria

April 18, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NUH-ALS-2015-04

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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