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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1250

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

17 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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Alloksys Life Sciences B.V.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Aix Scientifics

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2017

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 30, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 31, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 24, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 8, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 13, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 19, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 18, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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