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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03050476
Recruitment Status : Recruiting
First Posted : February 13, 2017
Last Update Posted : July 9, 2020
Sponsor:
Collaborator:
Aix Scientifics
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Systemic Inflammation Cardiopulmonary-bypass Drug: bRESCAP Drug: placebo Phase 2 Phase 3

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, late extubation, gastrointestinal or neurological complications or death within 30 days.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Preventing Oxidative Stress-induced Ischemic Injury- and Systemic Inflammation Complications During and After Invasive Cardiac Surgery With Alkaline Phosphatase (APPIRED III)
Actual Study Start Date : November 1, 2017
Estimated Primary Completion Date : July 13, 2021
Estimated Study Completion Date : September 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Surgery

Arm Intervention/treatment
Experimental: bRESCAP
Bolus of 1000 IU of bovine intestinal alkaline phosphatase on induction of anaesthesia, followed by an infusion of 9000 IU over the next 24 hours.
Drug: bRESCAP
intravenous application before, during, and for 24 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 hours.
Drug: placebo
intravenous application before, during, and for 24 hours after heart surgery




Primary Outcome Measures :
  1. Number of patients with acute kidney injury [ Time Frame: 30 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


Secondary Outcome Measures :
  1. cost-related outcome [ Time Frame: 30 days ]
    Cost (SGD) incurred on renal replacement therapy, ICU and hospital stay

  2. levels of a set of inflammatory markers [ Time Frame: 24 hours ]
    IL-6, IL-8, IL-10, TNF-alpha



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03050476


Contacts
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Contact: Ruud Brands, PhD +31 30 253 3615 ruud@alloksys.com
Contact: Eike G Fischer, PhD +49 241 4500 358 eike@aix-scientifics.com

Locations
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Australia, Melbourne
Dept. Cardiothoracic Surgery , Monash Medical Centre Recruiting
Clayton, Melbourne, Australia, VIC 3168
Contact: Julian A Smith, Prof.    +61 3 8572 2563    Julian.Smith@monash.edu   
Austria
MedUniWien / AKH-Wien Recruiting
Wien, Austria, 1090
Contact: Dominik Wiedemann, Prof. Dr.    +43-1-40400-6966    dominik.wiedemann@meduniwien.ac.at   
Contact: Günther Laufer, Univ. Prof. Dr       guenther.laufer@meduniwien.ac.at   
Belgium
Hospital ZOL Suspended
Genk, Belgium, 3600
Dept. of Anesthesia and Intensive Care, AZ Maria Middelares Recruiting
Gent, Belgium, 9000
Contact: Jan Heerman, Dr.    +32 9 246 17 21    Jan.Heerman@AZMMSJ.be   
Jessa Ziekenhuis,Campus Virga Jesse Recruiting
Hasselt, Belgium, 3500
Contact: Urbain Mees, Dr.    +32 11 -33 71 00    urbain.mees@cardiothoracalechirurgie.be   
Germany
German Heart Centre Munich, Dept.Cardio-Vascular Surgery Not yet recruiting
Munich, Bavaria, Germany, 80636
Contact: Rüdiger Lange, Prof. Dr.    +49 89 1218 2973      
Klinik für Herzchirurgie, Universitätsklinik Suspended
Leipzig, Germany, 04289
Italy
Policlinico Gemelli, Institute Cardiology Not yet recruiting
Roma, Italy, 00168
Contact: Massimo Massetti, Prof.MD    +39 06 - 3015 - 8762    Massimo.Massetti@unicatt.it   
Malaysia
Institut Jantung Negara (IJN , Natl. Heart Inst.) Recruiting
Kuala Lumpur, Malaysia, 50400
Contact: Pau Kiew Kong, Dr.    +603 2617 8200    paukk@ijn.com.my   
Contact: Jeffrey Jeswant Dillon, Prof Dr.       jeswant@ijn.com.my   
Netherlands
Dept. Cardiothoracic Surgery, Maastricht University Medical Centre Recruiting
Maastricht, Limburg, Netherlands, 6229 HX
Contact: Roberto Lorusso, Prof. Dr.    +31 43 387 1125    roberto.lorusso@mumc.nl   
Catharina Ziekenhuis, Cathreine R&D, Heartcentre Recruiting
Eindhoven, Netherlands, 5623 EJ
Contact: M.E.S.H. Tan, MD    +31 40 - 239 8360    erwin.tan@catharinaziekenhuis.nl   
Contact: Esther van Dooren       Esther.v.Dooren@catharinaziekenhuis.nl   
Portugal
Hospital de Santa Marta Not yet recruiting
Lisboa, Portugal, 1169-024
Contact: José Fragata, Prof. MD, PhD    +351 21 359 41 06    jigFragata@gmail.com   
Contact: Pedro Coelho, MD       pedropirescoelho@gmail.com   
Russian Federation
Almazov Heart Center Recruiting
St Petersburg, Russian Federation, 197341
Contact: Alexandra Konradi, Prof dr    +7 812 702-68-16    konradi@almazovcentre.ru   
Contact: Olga Bolsakova, Prof    +7 (812) 702-37-41    oobolshakova@yahoo.com   
Singapore
National University Hospital (NUH), Recruiting
Singapore, Singapore, 119228
Contact: Theodoros Kofidis, Prof.Dr.    +65 677 - 22059    Theodoros@nuhs.edu.sg   
Contact: Ram Ramanathan       Ram_Ramanathan@nuhs.edu.sg   
Sponsors and Collaborators
Alloksys Life Sciences B.V.
Aix Scientifics
Investigators
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Study Chair: Ruud Brands, PhD Alloksys Life Sciences BV . President
Principal Investigator: Theodoros Kofidis, Prof.Dr. National University Hospital (NUH), Singapore
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Responsible Party: Alloksys Life Sciences B.V.
ClinicalTrials.gov Identifier: NCT03050476    
Other Study ID Numbers: NUH-ALS-2015-04
First Posted: February 13, 2017    Key Record Dates
Last Update Posted: July 9, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Alloksys Life Sciences B.V.:
side-effects
heart-lung machine
alkaline phosphatase
Additional relevant MeSH terms:
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Inflammation
Pathologic Processes