Predicting Adverse Kidney Events of Cardiac Surgery-Associated Acute Kidney Injury Using Novel Biomarkers
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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, Critical Illness, Kidney Failure. 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
- Китай
- 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
Predicting Adverse Kidney Events of Cardiac Surgery-Associated Acute Kidney Injury Using Novel Biomarkers--A Multicenter Observational Study
Обзор
The aim of this study was to identify and validate novel biomarkers for predict acute kidney injury (AKI) subphenotype, major adverse kidney events and other poor outcomes.
Подробное описание
Cardiac surgery-associated acute kidney injury (CSA-AKI) is a serious condition that is associated with increased mortality and morbidity. However, the current criteria for assessing the severity of AKI may not adequately capture the heterogeneity of this condition. This can lead to difficulties in identifying treatment effects in specific patient subgroups, which may contribute to the growing number of negative interventional trials in AKI. To address this issue, researchers have developed and validated two subphenotypes of AKI: resolving and nonresolving. These subphenotypes are based on the trajectory of serum creatinine (SCr) levels in the first 3 days after hospital presentation. By stratifying AKI patients based on these subphenotypes, we can better assess their risk and predict outcomes.
Several novel biomarkers have been developed to aid in the early detection of AKI, discrimination of its underlying causes, and prediction of outcomes. However, it remains unclear whether these biomarkers can accurately predict the development of a nonresolving AKI subphenotype. In our present study, we aim to address this gap in knowledge by conducting a large cohort study. Our goal is to identify and validate novel biomarkers that can effectively detect the resolving subphenotype of AKI, as well as predict major adverse kidney events and other poor outcomes.
Первичные конечные точки
- AKI nonresolving subphenotype [Срок оценки: 7 days]
Вторичные конечные точки (8)
- Major adverse kidney events at 30 days [Срок оценки: 30 days]
- Major adverse kidney events at 90 days [Срок оценки: 90 days]
- Major adverse kidney events at 365 days [Срок оценки: 365 days]
- Mortality [Срок оценки: 365 days]
- Receipt of renal replacement treatment [Срок оценки: 365 days]
- Moderate and severe AKI [Срок оценки: 7 days]
- AKI progression [Срок оценки: 7 days]
- Composite Outcome [Срок оценки: 30 days]
Критерии участия
Критерии включения
- Patients undergoing cardiac surgery who experienced AKI within 48 hours of cardiac surgery were screened.
Критерии исключения
- History of End Stage Renal Disease or on Dialysis;
- prior kidney transplantation;
- patients with a DNR order;
- patients without written informed consent;
- pregnancy;
- moribund patients with expected death within 24 h or whose survival to 28 days was unlikely due to an uncontrollable comorbidity (i.e., end-stage liver or heart disease, untreatable malignancy)
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
Китай · 1 центр
- Shanghai Zhongshan Hospital — Шанхай
Идентификаторы
NCT: NCT06351813 · B2024-029R