Preventing Systemic Inflammation after Cardiac surgery with Alkaline Phosphatase (APPIRED III)

Phase 1

• Conditions: systemic inflammation as side-effect of heart-lung machine during cardiac surgery; MedDRA version: 20.0Level: LLTClassification code 10017501Term: Functional disturbances following cardiac surgerySystem Organ Class: 10022117 - Injury, poisoning and procedural complications; Therapeutic area: Body processes [G] - Immune system processes [G12]

• Registration Number: EUCTR2016-002663-33-AT
• Lead Sponsor: Alloksys Life Sciences BV

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-09-19
• Last Update Posted: 13 May 2024

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 1250

Inclusion Criteria

A potential subject must meet all of the following criteria to participate in the study:
1.> 21 years of age (legal adult in Singapore)
2.Undergoing cardiac surgery with planned cardiopulmonary bypass
3.EuroSCORE II >= 3
4.Ability to provide informed consent (not incapacitated)
5. Patient has given written informed consent prior to participation in the trial and
undertakes to comply with the protocol.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 625
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 625

Exclusion Criteria

Any subjects meeting the following criteria at baseline will be excluded:
1.Already on renal replacement therapy
2.Patients with chronic kidney disease defined as urinary albumin excretion of =30 mg/day, or equivalent or estimated glomerular filtration rate [eGFR] <60 mL/min/1.73 m2 for > 3 months.
3.Patients who are pregnant or lactating.
4.Concurrent enrolment in another clinical trial
5.Known allergic reaction to bovine alkaline phosphatase
6. Patient with ongoing infections or current use of steroids
7. Patient with high-risk emergency surgery or with follow-up procedures already
planned at admission (like e.g., TEVAR)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified