Acute Kidney Injury, Biomarkers, Cardiovascular Surgery, CSA-AKI
Conditions
Brief summary
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.
Interventions
None listed
Sponsors
China National Center for Cardiovascular Diseases
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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; * 5\. Patients undergoing kidney transplantation, peritoneal dialysis, or hemodialysis treatment; * 6\. Patients with malignant tumors or those with an expected lifespan of less than 12 months; * 7\. Angiography or preoperative acute heart failure; * 8\. Patients who have a history of massive hemorrhage in the past 30 days or have contraindications to anticoagulant therapy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The occurrence of CSA-AKI | The assessment will be conducted from the end of the surgery until the 7th day after the operation. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The occurrence of severe CSA-AKI(i.e. AKI stage 2 or 3) | The assessment will be conducted from the end of the surgery until the 7th day after the operation. | 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. |
| CSA-AKI as defined by the AKIN standard | From the preoperative period to 48 hours after the operation | 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. |
| The occurrence of persistent acute kidney injury | From the end of surgery through postoperative day 7 | 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. |
| Renal replacement therapy or in-hospital death | 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. | 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. |
| The length of stay in the ICU and the total length of stay | The length of stay in the ICU:From ICU admission until ICU discharge, up to 3 months after surgery The total length of stay:From hospital admission until hospital discharge, up to 1 year after surgery | Record the total number of days the patient was admitted to the ICU and the total number of days of this hospitalization |
| New-onset acute kidney disease (AKD） | Postoperative day 8 to 90 days | According to the KDIGO guidelines, a state where renal function remains persistently abnormal (serum creatinine or urine output does not return to baseline) for more than 7 days but less than 90 days after the occurrence of acute kidney injury |
| Major adverse cardiovascular events (MACE) within 1 year after surgery | From the end of surgery to 1 year after surgery | The composite endpoints that occurred within 1 year after surgery included cardiovascular death, myocardial infarction, heart failure and stroke. |
| Change in Estimated Glomerular Filtration Rate (eGFR) | From baseline to 1 year after cardiac surgery | The change in eGFR will be calculated as the difference between eGFR at 1 year after the index cardiovascular surgery and baseline eGFR, expressed in mL/min/1.73 m². |
| New CKD or progression of existing CKD | Within 1 year after cardiac surgery | Incidence of newly diagnosed chronic kidney disease or progression of pre-existing chronic kidney disease, based on KDIGO CKD criteria. |
| MAKE | Follow-up assessment was conducted from the end of the surgery until one year after the operation. | Composite endpoints that occurred within one year after surgery, including: a \> 50% decrease in eGFR from baseline, entry into end-stage renal disease (initiating maintenance dialysis or receiving kidney transplantation), or death related to kidney disease. |
| MACE | Follow-up assessment was conducted from the end of the surgery until one year after the operation. | The composite endpoints that occurred within one year after the operation, including cardiovascular death, myocardial infarction, heart failure and stroke. |
Countries
China
Contacts
CONTACTJianfang Cai
Outcome results
None listed