Identifying risk factors for kidney injury after heart surgery
PrEcision Medicine in the Management of Cardiovascular Surgery Associated AKI - PEAK: a Prospective Observational Cohort Study
This study is trying to find out what factors can help predict kidney problems after heart surgery in adults so that doctors can better understand who might be at risk.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Insel Gruppe AG, University Hospital Bern Academic / other |
| Locations | 1 site (Bern) |
| Trial ID | NCT06471621 on ClinicalTrials.gov |
What this trial studies
This observational study aims to define a risk profile for acute kidney injury (AKI) associated with cardiovascular surgery by analyzing clinical characteristics, operation parameters, and laboratory values. It seeks to determine if a combination of these factors can better predict patient outcomes compared to traditional risk factors. Participants include adults scheduled for elective heart or major artery surgery, and data will be collected before, during, and after the surgery to identify potential biomarkers and predictors of AKI. The study emphasizes the importance of frailty as a risk factor, alongside classical predictors like age and pre-existing kidney conditions.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and above scheduled for elective cardiovascular surgery.
Not a fit: Patients with a kidney transplant or those on renal replacement therapy will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved prediction and management of acute kidney injury in patients undergoing cardiovascular surgery.
How similar studies have performed: Previous observational studies have indicated the significance of frailty and other biomarkers in predicting AKI, suggesting that this approach may yield valuable insights.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients undergoing elective cardiovascular surgery, such as valvular replacement surgery, with or without combined coronary artery bypass graft (CABG), or thoracic or abdominal aortic surgery. * Written informed consent obtained prior to surgery. Exclusion Criteria: * Patients with a kidney transplant or on renal replacement therapy * Severe liver failure, defined by the presence of encephalopathy, Factor V \< 50% and INR \>1.5 on preoperative blood sample (within 4 weeks).
Where this trial is running
Bern
- University Hospital Bern (Inselspital) — Bern, Switzerland (Recruiting)
Study contacts
- Principal investigator: Uyen Huynh-Do, Prof. MD — University Hospital Bern (Inselspital)
- Study coordinator: Uyen Huynh-Do, Prof. MD
- Email: uyen.huynh-do@insel.ch
- Phone: +41316323144
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.