Precision Medicine in Cardiovascular Surgery Associated Acute Kidney Injury
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Acute Kidney Injury, Surgery-Complications, Frailty. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Switzerland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
PrEcision Medicine in the Management of Cardiovascular Surgery Associated AKI - PEAK: a Prospective Observational Cohort Study
Overview
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.
Detailed description
The difficulty of precisely predicting AKI following major surgery is a clinical challenge and unmet need as treatment should be introduced within 24-48 hours. In addition there is no available treatment to date apart from supportive therapy such as renal replacement therapy.
Therefore, early identification of patient-specific biomarkers and other clinical predictors could help to better understand the association with AKI and other patient outcomes. In addition to the "classical" risk factors (age, diabetes, pre-existing CKD), frailty might represent another important variable, as shown in previous observational studies. Importantly frailty is not unique to age, although it occurs in approximately 25% of those over 65 and affects more than half of the population aged 85 and older, as it has been shown to be highly prevalent in hospitalized patients and/or patients with CKD. Furthermore, in preclinical studies the serum protein Fetuin-A was identified as potential biomarker for vascular surgery associated AKI.
PEAK is a single center, prospective observational study involving several clinics at the University Hospital Bern. Besides from demographic data and perioperative parameters, blood and urine are collected with high granularity during and immediately after surgery (15min after the first cut, start and end of cardiopulmonary bypass (CBP) or aortic clamping (X-clamp), 4 hours after surgery) and at day 1, 2, 3, and 7 (or discharge) post-surgery. In addition renal function will be assessed at day 90. Furthermore, study participants will answer the Edmonton frailty questionnaire at baseline and at day 90.
Primary outcome measures
- Change from baseline of serum Fetuin-A values [Time frame: Baseline to day 90]
Secondary outcome measures (12)
- BMI [Time frame: Baseline and day 90]
- eGFR [Time frame: Baseline and day 90]
- Proteinuria [Time frame: Baseline and day 90]
- ASA score [Time frame: Baseline]
- Euroscore II [Time frame: Baseline]
- STS score (only for cardiac surgery) [Time frame: Baseline]
- Duration of ECC (only for cardiac surgery) [Time frame: Peri-operative]
- Duration of X-clamp (only for aortic surgery) [Time frame: Peri-operative]
- Lowest body temperature [Time frame: Peri-operative]
- SAPS II score [Time frame: After Operation to day 7]
- Urine output [Time frame: 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 [Time frame: Baseline to day 7]
Eligibility 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).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Switzerland · 1 center
- University Hospital Bern (Inselspital) — Bern
Publications
- Hammer N, Rudloff S, Waskowski J, Pfortmuller C, Pingpoh C, Chaikhouni B, Herzig S, Rheinberger M, Pedersen E, Luder G, Kotelis D, Siepe M, Erdoes G, Schefold J, Huynh-Do U. Protocol of the exploratory prospective observational PEAK study: PrEcision medicine in the management of cardiovascular surgery associated Acute Kidney Injury (AKI). BMJ Open. 2025 Jul 30;15(7):e095817. doi: 10.1136/bmjopen-2 PMID 40744512
Identifiers
NCT: NCT06471621 · DLF-Nr: 5658 · BASEC-Nr: 2023-02024