Preventing Oxidative stress-induced ischemic injury and systemic inflammation complications during and after invasive cardiac surgery with Alkaline Phosphatase (APPIRED III)

Phase 3

Recruiting

• Conditions: renal failure; systemic inflammatory response; 10046973; 10029149

• Registration Number: NL-OMON49105
• Lead Sponsor: Alloksys Life Sciences BV

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 150

Inclusion Criteria

A potential subject must meet all of the following criteria to participate in the study:
1. greater than 21 years of age (legal adult in Singapore)
2. Undergoing cardiac surgery with planned cardiopulmonary bypass
3. EUROSCORE II greater than or equal 3
4. Ability to provide informed consent (not incapacitated)

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 lower than 60 ml/min/1.73 m2 ( CKD stage > 2)
3. Patients who are pregnant
4. Concurrent enrolment in another clinical trial
5. Known allergic reaction to bovine alkaline phosphatase

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified