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Acute Kidney InjuryPEAKNCT06471621

Precision Medicine in Cardiovascular Surgery Associated Acute Kidney Injury

An observational study of Acute Kidney Injury and Surgery-Complications, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
How many people
100 participants
Where
1 siteSwitzerland
Study dates
16 Jun 2024to 31 Oct 2026
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients undergoing elective cardiovascular surgery at the University Hospital Bern (Inselspital), Switzerland

Who may be able to join

  • 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.

Who cannot join

  • 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).

Trial locations and contacts

1 site in 1 country.

Uyen Huynh-Do, Prof. MD contact

+41316323144

uyen.huynh-do@insel.ch

Stefan Rudloff, PhD contact

+41316329817

stefan.rudloff@unibe.ch

Switzerland1 site, 1 recruiting

  • University Hospital Bern (Inselspital)

    Bern, 3010

    Uyen Huynh-Do, Prof. MD, +41316323141, uyen.huynh-do@insel.ch

    Stefan Rudloff, PhD, +41316329817, stefan.rudloff@unibe.ch

    Recruiting

Other trials in Switzerland

About this study

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

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.

Read the 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.

Keywords
Kidney, Renal, Cardiac, Thoracic, Abdominal, Valvular replacement, CABG, Aneurysm, cardiopulmonary bypass, Ischemia
Medical subject headings
Acute Kidney Injury, Frailty, Aneurysm, Ischemia

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from baseline of serum Fetuin-A values

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

    Measured: Baseline to day 90

Secondary outcomes (15)

  1. BMI

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

    Measured: Baseline and day 90

  2. eGFR

    estimated glomerular filtration rate in (ml/min)

    Measured: Baseline and day 90

  3. 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

    Measured: Baseline and day 90

  4. 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

    Measured: Baseline

  5. Euroscore II

    Euroscore II, predicted mortality in (%)

    Measured: Baseline

  6. STS score (only for cardiac surgery)

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

    Measured: Baseline

  7. Duration of ECC (only for cardiac surgery)

    Time on extracorporeal circuit in (min)

    Measured: Peri-operative

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

    Time of X-clamping in (min)

    Measured: Peri-operative

  9. Lowest body temperature

    Lowest body temperature recorded during surgery in (°C)

    Measured: Peri-operative

  10. 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

    Measured: After Operation to day 7

  11. Urine output

    Daily urine volume in (ml)

    Measured: After Operation to day 7

  12. 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).

    Measured: Baseline to day 7

  13. 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.

    Measured: Baseline to day 90

  14. 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).

    Measured: Baseline and day 90

  15. Grip strength

    Grip strength of dominant hand in kg

    Measured: Baseline and day 90

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jun 2024
  2. Study start16 Jun 2024
  3. Primary completion31 Jan 2026 (estimated)
  4. Study completion31 Oct 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06471621
Sponsor's protocol ID
DLF-Nr: 5658
Other IDs
BASEC-Nr: 2023-02024
Acronym
PEAK
Status last verified
Jul 2024
First submitted
24 Apr 2024
Last updated
19 Jul 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

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-2024-095817.

    PubMed 40744512

Questions about this trial

What is this clinical trial studying?

An observational study of Acute Kidney Injury and Surgery-Complications, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 19 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Uyen Huynh-Do, Prof. MD (+41316323144, uyen.huynh-do@insel.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline of serum Fetuin-A values (time frame: Baseline to day 90). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06471621, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2024.

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