Predicting Poor Outcomes of Cardiac Surgery-Associated Acute Kidney Injury Using Novel Biomarkers
- Conditions
- Acute Kidney InjuryCritical Illness
- Registration Number
- NCT04962412
- Lead Sponsor
- Guowei Tu
- Brief Summary
The aim of this study was to identify and validate novel biomarkers including functional tests for detecting AKI, AKI progression and other poor outcomes.
- Detailed Description
Cardiac surgery-associated acute kidney injury (CSA-AKI) is the second most common type of AKI after septic AKI and is associated with increased mortality and morbidity. The progression of AKI with multiple organ failure can result in poor outcomes. Several novel biomarkers for earlier detection of AKI, discrimination of etiologies, and prediction of outcomes were developed. However, the availability of these novel biomarkers may be limited by its expense or reimbursement issues in different countries. In present study, we conduct a large cohort to identify and validate novel biomarkers including functional tests for detecting AKI, AKI progression and other poor outcomes.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 5010
- Patients undergoing cardiac surgery were prospectively enrolled.
- 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)
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method AKI progression 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.
- Secondary Outcome Measures
Name Time Method AKI occurrence at 7 days 7 days AKI was defined based on the Kidney Disease Improving Global Outcomes (KDIGO) criteria.
Persistent AKI 90 days Persistent AKI is characterized by the continuance of AKI by serum creatinine or urine output criteria (as defined by KDIGO) beyond 48h from AKI onset.
Mortality 365 days Mortality at 30 days, 90 days and 365 days
AKI progression to stage 3 7 days worsening of KDIGO stage to stage 3 within 1 week (progressing from stage 1 or stage 2 to stage 3).
AKI occurrence at 3 days 3 days AKI was defined based on the Kidney Disease Improving Global Outcomes (KDIGO) criteria.
Length of stay in the ICU 90 days Length of stay in the ICU
Receipt of renal replacement treatment 365 days Patients received renal replacement treatment during hospital stay
Major adverse kidney events 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 MDRD equation
Persist severe AKI 90 days Persistent severe AKI was defined as follows: Patients with stage 3 AKI at enrollment required a persistence of 72 hours or more to meet the end point.
Patients enrolled at stage 2 AKI required a progression to stage 3 within 48 hours and a persistence at stage 3 for 72 consecutive hours to be considered end point positive.
Additionally, patients with severe AKI who failed to achieve 72 hours due to death or the initiation of RRT were considered end point positive.Length of stay in the hospital 90 days Length of stay in the hospital
Trial Locations
- Locations (1)
Zhongshan hospital, Fudan university
🇨🇳Shanghai, China