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NCT Number: NCT06471621

Precision Medicine in Cardiovascular Surgery Associated Acute Kidney Injury

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.

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Key information

Conditions

Acute Kidney Injury Aneurysm Cardiovascular Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Frailty Ischemia Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Surgery-Complications Urogenital Diseases Urologic Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Primary outcomes

  1. Change from baseline of serum Fetuin-A values

    Time frame: Baseline to day 90

    Measurement of serum Fetuin-A at baseline and at the various sampling time-points mentioned above.

Secondary outcomes

  1. BMI

    Time frame: Baseline and day 90

    Body mass index of participants in (kg/m2), integer: min 15 (extreme underweight), max 45 (extreme overweight)

  2. eGFR

    Time frame: Baseline and day 90

    estimated glomerular filtration rate in (ml/min)

  3. Proteinuria

    Time frame: Baseline and day 90

    Albumin in urine normalized to creatinine in categorized into 3 groups:

    • <30 mg/d
    • 30-300 mg/d
    • >300 mg/d

  4. ASA score

    Time frame: Baseline

    American Society of Anesthesiology classification of physical status (1-6)

    • - Normal health
    • - Mild systemic disease
    • - Severe systemic disease
    • - Severe systemic disease that is constant threat to life
    • - Moribund, not expected to survive 24h with or without operation
    • - Declared brain-dead

  5. Euroscore II

    Time frame: Baseline

    Euroscore II, predicted mortality in (%)

  6. STS score (only for cardiac surgery)

    Time frame: Baseline

    Society of Thoracic Surgeons Score in (%), higher values predict higher risk

  7. Duration of ECC (only for cardiac surgery)

    Time frame: Peri-operative

    Time on extracorporeal circuit in (min)

  8. Duration of X-clamp (only for aortic surgery)

    Time frame: Peri-operative

    Time of X-clamping in (min)

  9. Lowest body temperature

    Time frame: Peri-operative

    Lowest body temperature recorded during surgery in (°C)

  10. SAPS II score

    Time frame: After Operation to day 7

    Simplified Acute Physiology Score (SAPS) II°C), in-hospital mortality at ICU admission, integer min 1, max 200, higher values predict higher mortality

  11. Urine output

    Time frame: After Operation to day 7

    Daily urine volume in (ml)

  12. 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

    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).

  13. Assessment of AKI to CKD progression at day 90 in association with change in serum Fetuin-A levels over time

    Time frame: Baseline to day 90

    CKD will be evaluated as a binary outcome (presence/absence) based on renal functional parameters.

  14. Assessment of the patient-reported outcome measure (PROM) frailty in association with progression to CKD and worse clinical outcome

    Time frame: Baseline and day 90

    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).

  15. Grip strength

    Time frame: Baseline and day 90

    Grip strength of dominant hand in kg

Study contacts

Contact information is provided by the study sponsor or research team.

Stefan Rudloff, PhD

CONTACT

[email protected]

+41316329817

Uyen Huynh-Do, Prof. MD

CONTACT

[email protected]

+41316323144

Sponsors and collaborators

Lead sponsor

Insel Gruppe AG, University Hospital Bern

Other

Collaborators

  • CSL Behring

Registry information

Official study title

PrEcision Medicine in the Management of Cardiovascular Surgery Associated AKI - PEAK: a Prospective Observational Cohort Study

Acronym: PEAK

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jun 24, 2024
Registry last updated
Jul 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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