Precision Medicine in Cardiovascular Surgery Associated Acute Kidney Injury
NCT Number: NCT06471621
Acronym: PEAK
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Acute Kidney Injury|Surgery-Complications|Frailty
Sponsor: Insel Gruppe AG, University Hospital Bern
Collaborators: CSL Behring
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-06-16
Completion Date: 2026-10-31
Locations: University Hospital Bern (Inselspital), Bern, 3010, Switzerland

Summary:
The goal of this prospective observational study is to define a risk profile for cardiovascular surgery associated acute kidney injury (AKI), using clinical patient characteristics, operation parameters as well as blood and urine laboratory values.

The main question it aims to answer is:

• Does a combination of the factors mentioned above better predict patient outcome than classical factors used to date in clinical practice?

Participants of this study are adults aged 18 and above who are scheduled for elective heart or main artery surgery, and who have given written informed consent.

Primary Outcome Measures: Change from baseline of serum Fetuin-A values, Measurement of serum Fetuin-A at baseline and at the various sampling time-points mentioned above., Baseline to day 90
Secondary Outcome Measures: BMI, Body mass index of participants in (kg/m2), integer: min 15 (extreme underweight), max 45 (extreme overweight), Baseline and day 90|eGFR, estimated glomerular filtration rate in (ml/min), Baseline and day 90|Proteinuria, Albumin in urine normalized to creatinine in categorized into 3 groups:

1. \<30 mg/d
2. 30-300 mg/d
3. \>300 mg/d, Baseline and day 90|ASA score, American Society of Anesthesiology classification of physical status (1-6)

1. - Normal health
2. - Mild systemic disease
3. - Severe systemic disease
4. - Severe systemic disease that is constant threat to life
5. - Moribund, not expected to survive 24h with or without operation
6. - Declared brain-dead, Baseline|Euroscore II, Euroscore II, predicted mortality in (%), Baseline|STS score (only for cardiac surgery), Society of Thoracic Surgeons Score in (%), higher values predict higher risk, Baseline|Duration of ECC (only for cardiac surgery), Time on extracorporeal circuit in (min), Peri-operative|Duration of X-clamp (only for aortic surgery), Time of X-clamping in (min), Peri-operative|Lowest body temperature, Lowest body temperature recorded during surgery in (°C), Peri-operative|SAPS II score, Simplified Acute Physiology Score (SAPS) II°C), in-hospital mortality at ICU admission, integer min 1, max 200, higher values predict higher mortality, After Operation to day 7|Urine output, Daily urine volume in (ml), After Operation to day 7|Assessment of AKI incidence and severity at day 7 in association with change in serum Fetuin-A levels over time, AKI will be assessed as a binary outcome (presence/absence)

Biomarkers for AKI severity include levels of direct Fetuin-A targets, kidney function parameters, predictors of AKI or CKD (NGAL, suPAR, Nephrocheck®, or YKL-40), hemolysis (hemoglobin, transferrin), inflammatory mediators (cytokines, chemokines or growth factors), and exploratory assessments (proteomics, metabolomics)., Baseline to day 7|Assessment of AKI to CKD progression at day 90 in association with change in serum Fetuin-A levels over time, CKD will be evaluated as a binary outcome (presence/absence) based on renal functional parameters., Baseline to day 90|Assessment of the patient-reported outcome measure (PROM) frailty in association with progression to CKD and worse clinical outcome, Frailty in terms of patient-related outcome will be reported as a paired difference of mean frailty score (Edmonton Frail Scale) between baseline and 90-days visit. The scale ranges from 0 (not frail) to 17 (severe frailty)., Baseline and day 90|Grip strength, Grip strength of dominant hand in kg, Baseline and day 90