Loading clinical trials...

Preventing Systemic Inflammation After Cardiac Surgery With Alkaline Phosphatase | Clinical Trials | Clareo Health

RECRUITINGPHASE2/PHASE3

Preventing Systemic Inflammation After Cardiac Surgery With Alkaline Phosphatase

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

NCT03050476•Alloksys Life Sciences B.V.

View on ClinicalTrials.gov

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.

Eligibility

Age

21 - No limit years

Sex

ALL

Healthy Volunteers

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)

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

Vienna, 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

Ghent, 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

Key Dates

Start Date

November 1, 2017

Primary Completion Date

September 30, 2025

Completion Date

March 31, 2026

Last Updated

April 19, 2024

Enrollment

1,250

ESTIMATED participants

Conditions

Systemic InflammationCardiopulmonary-bypass

Interventions

RESCAP®

DRUG

placebo

DRUG

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

A Research Study Looking Into How Ziltivekimab Works Compared to Placebo in Participants With Heart Failure and Inflammation

NCT06200207

Heart FailureSystemic Inflammation

View study

RECRUITING

Effects of Spinal vs General Anesthesia on Systemic Inflammation in PCNL

NCT07326670

Anesthesia TechniquesPercutaneous Nephrolithotomy+1 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 19, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Preventing Systemic Inflammation After Cardiac Surgery With Alkaline Phosphatase

Inclusion Criteria

Exclusion Criteria

A Research Study Looking Into How Ziltivekimab Works Compared to Placebo in Participants With Heart Failure and Inflammation

Effects of Spinal vs General Anesthesia on Systemic Inflammation in PCNL

Assessment of Metformin for Restoration of Immune Homeostasis in HIV+ and HIV- Individuals With a History of Injection Drug Use

Longitudinal Evaluation of Regenerative Treatment of Peri-implantitis Assited by Er,Cr:YSGG Laser: up to 10 Years Follow-up

Cardiopulmonary Inflammation and Multi-System Imaging During the Clinical Course of COVID-19 Infection in Asymptomatic and Symptomatic Persons

A Research Study of How the Medicine Ziltivekimab Works in the Body of Chinese Men and Women With Kidney Disease and Inflammation