Predicting Adverse Kidney Events of Cardiac Surgery-Associated Acute Kidney Injury Using Novel Biomarkers--A Multicenter Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 358
- 试验地点
- 1
- 主要终点
- AKI nonresolving subphenotype
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing cardiac surgery who experienced AKI within 48 hours of cardiac surgery were screened.
排除标准
- •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)
结局指标
主要结局
AKI nonresolving subphenotype
时间窗: 7 days
The resolving subphenotype was defined by a decrease of 0.3 mg/dl or 25% in SCr from its maximum during the first 3 days of study enrollment. All subjects with AKI who did not meet this criterion were classified as having a nonresolving subphenotype
次要结局
- Major adverse kidney events at 90 days(90 days)
- Major adverse kidney events at 365 days(365 days)
- Composite Outcome(30 days)
- Major adverse kidney events at 30 days(30 days)
- Mortality(365 days)
- Receipt of renal replacement treatment(365 days)
- AKI progression(7 days)
- Moderate and severe AKI(7 days)
研究者
Guowei Tu
Professor
Shanghai Zhongshan Hospital