Prognostic Value of Novel Biomarkers on Adverse Renal Outcomes in High-Risk Cardiac Surgery Patients
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-90
SponsorGuowei Tu
About this trial
This project aims to detect novel biomarkers from preoperative and early postoperative serum and urine samples of patients to screen and analyze the risk factors for predicting adverse postoperative renal outcomes in high-risk patients in cardiac surgery.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
age >70 years;
30 < estimated glomerular filtration rate (eGFR) <60 mL·min-1·1.73 m-2;
diabetes mellitus, proteinuria;
a history of congestive heart failure within the previous year;
Disqualifiers
pre-existing chronic kidney disease (preoperative estimated glomerular filtration rate [eGFR] < 30 mL/min/1.73 m2);
previous RRT before cardiac surgery;
present AKI at screening;
a history of kidney transplant or other kidney diseases;
Trial population
All high-risk AKI patients who underwent cardiac surgery at Zhongshan Hospital Affiliated to Fudan University.CSA-AKI is the second most common cause of AKI in the intensive care setting (after sepsis) and is independently associated with increased morbidity and mortality. The incidence of cardiac surgery-associated AKI (CSA-AKI) varies from 5% to 42%.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Standard care "bundle"
Other interventionThe management for AKI patients were performed by implementing a standard care "bundle" suggested by the Kidney Disease Improving Global Outcome (KDIGO) guideline.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
AKI occurrence within 7 days
AKI was defined based on the Kidney Disease Improving Global Outcomes (KDIGO) criteria.
Time frame
7 daysSecondary outcomes
1
Moderate and severe AKI occurrence within 7 days
Stage 2 and stage 3 AKI based on KDIGO criteria.
Time frame
7 days2
AKI occurrence within 48 hours
AKI was defined based on the Kidney Disease Improving Global Outcomes (KDIGO) criteria.
Time frame
48 hours3
AKI occurrence within 3 days
AKI was defined based on the Kidney Disease Improving Global Outcomes (KDIGO) criteria.
Time frame
3 days4
Major adverse kidney events
MAKE at discharge 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
PerioperativeSponsors and contacts
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Guowei Tu
Lead sponsor
Shanghai Zhongshan Hospital
Sponsor institution
Source ClinicalTrials.gov