Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:32 AM
Ignite Modification Date:
2025-12-25 @ 2:32 AM
NCT ID:
NCT07108634
Eligibility Criteria:
Inclusion Criteria:
1. Patients undergoing cardiac surgery (elective or in-house urgent) from Jan 1st, 2013, to December 31st, 2023 (excluding patients during 2020 \& 2021 - due to confounding Covid-19 impact on AKI)
2. Cardiopulmonary bypass machine was used during cardiac surgery
3. Patient's data available in the databases (Minimum dataset required for propensity matching: age, gender, diabetes history, LVEF, priority of surgery, pre-op haemoglobin \& SCr levels, cardiac surgery performed, CPB duration, Euroscore or LogEuroscore, RRT use, post-op D1\&/or D2 \&/or D3 SCr)
Exclusion Criteria:
1. Emergency surgery
2. Patient with incomplete dataset\*
3. Surgery performed without CPB
4. Patients already dialysis dependent
5. Patient with eGFR \<20 mL/min/1.73 m²
6. Cardiac surgery requiring deep hypothermic circulatory arrest (DHCA)
7. Patients previously treated with RenalGuard® Therapy
8. Patient has opted-out of research (data opt-out) \* Data completeness - These variables need to be complete for the propensity matching: age, gender, diabetes history, LVEF, priority of surgery, pre-op haemoglobin \& SCr levels, cardiac surgery performed, CPB duration, Euroscore or LogEuroscore, RRT use, post-op D1\&/or D2 \&/or D3 SCr
Sex:
ALL
Study:
NCT07108634
Study Brief:
Protocol Section:
NCT07108634