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)

Status

Recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03050476

Acronym

APPIRED-III

Enrollment

1250

Registered

2017-02-13

Start date

2017-11-01

Completion date

2026-03-31

Last updated

2024-04-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiopulmonary-bypass, Systemic Inflammation

Keywords

side-effects, heart-lung machine, alkaline phosphatase

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.

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.

Interventions

DRUGRESCAP®

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

DRUGplacebo

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

21 Years to No maximum

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)

Design outcomes

Primary

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

Secondary

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

Countries

Australia, Austria, Belgium, Germany, Italy, Malaysia, Netherlands, Portugal, Russia, Singapore, Spain

Contacts

Primary ContactRuud Brands, PhD

ruud@alloksys.com+31 647 228 395

Backup ContactEike G Fischer, PhD

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026