Discovery and Validation of Biomarkers for CSA-AKI Risk Prediction
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorChina National Center for Cardiovascular Diseases
About this trial
This study aims to discover and validate new biomarkers for predicting CSA-AKI before cardiovascular surgery.
Nested case-control studies embedded in prospective cohorts. Adult patients scheduled for cardiovascular surgery were continuously included. Blood/urine/stool samples and clinical data before and after contrast agent exposure and before and after cardiovascular surgery were collected, and the occurrence, progression and outcome of CSA-AKI events were dynamically monitored. Based on the exposure to contrast agents and the occurrence of CSA-AKI, two case-controls were constructed in the prospective cohort. In the construction of two case-controls, biomarkers were identified and validated by using multi-omics analysis techniques and machine learning techniques, etc.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
1. Age no less than 18 years old;
2. Scheduled cardiovascular surgery is proposed;
3. Pre-angiography and preoperative serum creatinine <354 μ mol/L;
4. Informed consent.
Disqualifiers
1. Women who have a pregnancy plan within one year, are pregnant, or are breastfeeding;
2. Patients who have severe side effects such as allergies to iodine contrast agents;
3. Patients with hyperthyroidism;
4. Those who had AKI before the contrast agent or within 2 weeks before the operation, or whose AKI has not been relieved after the operation;
Trial population
Adult patients scheduled for elective cardiovascular surgery were continuously included in the study.
Trial design
Design model
Other
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
The occurrence of CSA-AKI
CSA-AKI is defined as: serum creatinine (SCr) within 48 hours after cardiovascular surgery increases by ≥26.5 µmol/L compared with the baseline, or SCr increases by ≥ 50% times the baseline value within 7 days after surgery, or urine output is less than 0.5 mL/kg/h and persists for more than 6 hours.
Time frame
The assessment will be conducted from the end of the surgery until the 7th day after the operation.Secondary outcomes
1
The occurrence of severe CSA-AKI(i.e. AKI stage 2 or 3)
Acute kidney injury at stage 2 or stage 3 as defined by the KDIGO 2012 guidelines.AKI stage 2 is defined as:meet any of the following conditions: 1. Serum creatinine index: Serum creatinine rises to 2.0-2.9 times the baseline value. 2. Urine volume index: Urine volume remains consistently below 0.5 mL/kg/h for more than 12 hours. AKI stage 3 is defined as: meeting any of the following conditions: 1. Serum creatinine index: Serum creatinine increases to 3.0 times or more of the baseline value; Or the serum creatinine level rises to ≥ 4.0 mg/dL (≥ 353.6 μmol/L); Or start renal replacement therapy (such as hemodialysis, peritoneal dialysis). 2. Urine volume index: Urine volume remains consistently below 0.3 mL/kg/h for more than 24 hours; Or anuria (urine output \< 100 mL/ day) persists for 12 hours or more.
Time frame
The assessment will be conducted from the end of the surgery until the 7th day after the operation.2
CSA-AKI as defined by the AKIN standard
CSA-AKI as defined by AKIN: that is, the increase of serum creatinine within 48 hours is \>26.5umol/L or \> 50% of the baseline.
Time frame
From the preoperative period to 48 hours after the operation3
The occurrence of persistent acute kidney injury
Persistent acute kidney injury is defined as acute kidney injury that persists for more than 48 hours after its initial diagnosis, based on serum creatinine and/or urine output according to KDIGO criteria.
Time frame
From the end of surgery through postoperative day 74
Renal replacement therapy or in-hospital death
Receiving any form of renal replacement therapy (such as continuous renal replacement therapy, intermittent hemodialysis, etc.) or any in-hospital death caused by any reason.
Time frame
From the end of cardiac surgery until the date of first occurrence of renal replacement therapy or in-hospital death, whichever came first, assessed up to 1 year after cardiac surgery.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov