Shanghai Zhongshan Hospital
Shanghai, Shanghai Municipality, 200032, China
NCT Number: NCT06351813
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.
Trial opening soon.
Get Notified18 year and older
All sexes
Observational
Shanghai, Shanghai Municipality, 200032, China
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.
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Time frame: 30 days
Major adverse kidney events (MAKE) was defined as the composite of≥25% loss in estimated glomerular filtration rate (eGFR), dialysis, or death. Estimated GFR was calculated from serum creatinine using the MDRD equation.
Time frame: 90 days
MAKE was defined as the composite of≥25% loss in estimated glomerular filtration rate (eGFR), dialysis, or death. Estimated GFR was calculated from serum creatinine using the MDRD equation.
Time frame: 365 days
MAKE was defined as the composite of≥25% loss in estimated glomerular filtration rate (eGFR), dialysis, or death. Estimated GFR was calculated from serum creatinine using the modification of diet in renal disease (MDRD) equation.
Time frame: 365 days
Mortality at 30 days, 90 days and 365 days
Time frame: 365 days
Patients received renal replacement treatment during hospital stay
Time frame: 7 days
Kidney Disease Improving Global Outcomes (KDIGO) stage 2 or stage 3
Time frame: 7 days
worsening of KDIGO stage within 1 week (progressing from stage 1 to either stage 2 or stage 3, or from stage 2 to stage 3).
Patients diagnosed with progressive or persisting stage 3 AKI (stage 3 AKI for >3 consecutive days) were classified as having AKI progression.
If patients who presented with stage 3 AKI but not requiring RRT subsequently required dialysis or developing persist severe AKI or death within 7 days, this was considered progression.
Time frame: 30 days
Stage 3 AKI, renal replacement therapy or death through outpatient or telephone follow-up
Contact information is provided by the study sponsor or research team.
Shanghai Zhongshan Hospital
Other
Predicting Adverse Kidney Events of Cardiac Surgery-Associated Acute Kidney Injury Using Novel Biomarkers--A Multicenter Observational Study
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07365111
Acute Kidney Injury, Continuous Renal Replacement Therapy (CRRT)
Edmonton, Alberta, Canada
View Trial DetailsNCT07464431
Acid-Base Imbalance, Acidosis
View Trial DetailsNCT07472452
Acute Kidney Injury, Critical Illness
View Trial DetailsNCT07293078
Acute Kidney Injury, Acute Respiratory Failure (ARF)
Framingham, Massachusetts, United States
View Trial Details