Predicting Adverse Kidney Events of Cardiac Surgery-Associated Acute Kidney Injury Using Novel Biomarkers
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Acute Kidney Injury, Critical Illness, Kidney Failure. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Predicting Adverse Kidney Events of Cardiac Surgery-Associated Acute Kidney Injury Using Novel Biomarkers--A Multicenter Observational Study
Overview
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.
Primary outcome measures
- AKI nonresolving subphenotype [Time frame: 7 days]
Secondary outcome measures (8)
- Major adverse kidney events at 30 days [Time frame: 30 days]
- Major adverse kidney events at 90 days [Time frame: 90 days]
- Major adverse kidney events at 365 days [Time frame: 365 days]
- Mortality [Time frame: 365 days]
- Receipt of renal replacement treatment [Time frame: 365 days]
- Moderate and severe AKI [Time frame: 7 days]
- AKI progression [Time frame: 7 days]
- Composite Outcome [Time frame: 30 days]
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Shanghai Zhongshan Hospital — Shanghai
Identifiers
NCT: NCT06351813 · B2024-029R