Predicting Adverse Kidney Events of Cardiac Surgery-Associated Acute Kidney Injury Using Novel Biomarkers--A Multicenter Observational Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Acute Kidney Injury
- Sponsor
- Shanghai Zhongshan Hospital
- Enrollment
- 358
- Locations
- 1
- Primary Endpoint
- AKI nonresolving subphenotype
- Status
- Not yet recruiting
- Last Updated
- last year
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Guowei Tu
Professor
Shanghai Zhongshan Hospital
Eligibility Criteria
Inclusion Criteria
- •Patients undergoing cardiac surgery who experienced AKI within 48 hours of cardiac surgery were screened.
Exclusion Criteria
- •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)
Outcomes
Primary Outcomes
AKI nonresolving subphenotype
Time Frame: 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
Secondary Outcomes
- 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)