Predicting Adverse Kidney Events of Cardiac Surgery-Associated Acute Kidney Injury Using Novel Biomarkers
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorShanghai Zhongshan Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients undergoing cardiac surgery who experienced AKI within 48 hours of cardiac surgery were screened.
Disqualifiers
History of End Stage Renal Disease or on Dialysis;
prior kidney transplantation;
patients with a DNR order;
patients without written informed consent;
Trial population
Adult patients with age ≥ 18 years who experienced AKI within 48 hours of cardiac surgery were included in this study.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
AKI nonresolving subphenotype
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
7 daysSecondary outcomes
1
Major adverse kidney events at 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
30 days2
Major adverse kidney events at 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
90 days3
Major adverse kidney events at 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 days4
Mortality
Mortality at 30 days, 90 days and 365 days
Time frame
365 daysSponsors and contacts
Click on the lead sponsor to view all of their trials.
Shanghai Zhongshan Hospital
Lead sponsor
Zhongshan Hospital (Xiamen), Fudan University
Collaborator
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Collaborator
Source ClinicalTrials.gov
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