Preventing Systemic Inflammation After Cardiac Surgery With Alkaline Phosphatase

Launched by ALLOKSYS LIFE SCIENCES B.V. · Feb 8, 2017

Keywords

ClinConnect Summary

This clinical trial is studying whether a treatment called alkaline phosphatase can help prevent inflammation and reduce the risk of kidney injury in patients undergoing heart surgery that requires a procedure called cardiopulmonary bypass. The goal is to see if this treatment can make a difference in recovery after surgery.

To be eligible for this trial, participants should be planning to have heart surgery with cardiopulmonary bypass and have certain health conditions, like a specific score that indicates higher surgical risk. It’s important that patients can understand and give their consent to participate. However, individuals who already need kidney treatment, have severe kidney disease, are pregnant or breastfeeding, or have certain other health issues won't be able to join. For those who do participate, they will receive the treatment and be monitored closely during their recovery to see how well it works.

Gender

ALL

Eligibility criteria

• 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)