Preventing oxidative stress-induced ischemic injury and systemic inflammation complications during and after invasive cardiac surgery with alkaline phosphatase (APPIRED III)

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2025-520551-84-00

Acronym

NUH-ALS-2015-04

Enrollment

500

Registered

2025-01-30

Start date

Unknown

Completion date

Unknown

Last updated

2025-08-28

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

Conditions

systemic inflammation as side-effect of heart-lung machine during cardiac surgery

Brief summary

• Stop administering placebo but continue with experimental drug if AKI (defined by AKIN) is significantly lower in the experimental group or mortality is significantly lower in the experimental group., • Stop if all cause mortality, cardiac mortality, acute kidney injury, or the primary compound outcome is significantly higher in the experimental group, • Stop if more than 5% of patients have a serious adverse/allergic reaction to the administration of the drug

Interventions

DRUGRESCAP iv

DRUGThe placebo is identical with the IMP

DRUGbut without active substance

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
• Stop administering placebo but continue with experimental drug if AKI (defined by AKIN) is significantly lower in the experimental group or mortality is significantly lower in the experimental group., • Stop if all cause mortality, cardiac mortality, acute kidney injury, or the primary compound outcome is significantly higher in the experimental group, • Stop if more than 5% of patients have a serious adverse/allergic reaction to the administration of the drug	—

Measure

Time frame

—

Countries

Austria, Belgium

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026