Precision Medicine in Cardiovascular Surgery Associated Acute Kidney Injury
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Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
- Кому может быть актуально
- Состояния в реестре: Acute Kidney Injury, Surgery-Complications, Frailty. Базовые параметры: от 18 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Швейцария
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
PrEcision Medicine in the Management of Cardiovascular Surgery Associated AKI - PEAK: a Prospective Observational Cohort Study
Обзор
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.
Подробное описание
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.
Первичные конечные точки
- Change from baseline of serum Fetuin-A values [Срок оценки: Baseline to day 90]
Вторичные конечные точки (12)
- BMI [Срок оценки: Baseline and day 90]
- eGFR [Срок оценки: Baseline and day 90]
- Proteinuria [Срок оценки: Baseline and day 90]
- ASA score [Срок оценки: Baseline]
- Euroscore II [Срок оценки: Baseline]
- STS score (only for cardiac surgery) [Срок оценки: Baseline]
- Duration of ECC (only for cardiac surgery) [Срок оценки: Peri-operative]
- Duration of X-clamp (only for aortic surgery) [Срок оценки: Peri-operative]
- Lowest body temperature [Срок оценки: Peri-operative]
- SAPS II score [Срок оценки: After Operation to day 7]
- Urine output [Срок оценки: 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 [Срок оценки: Baseline to day 7]
Критерии участия
Критерии включения
- 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.
Критерии исключения
- 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).
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
Швейцария · 1 центр
- University Hospital Bern (Inselspital) — Bern
Публикации
- 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
Идентификаторы
NCT: NCT06471621 · DLF-Nr: 5658 · BASEC-Nr: 2023-02024