Establishment and Validation of an Early Warning Model for Acute Kidney Injury During the Perioperative Period of Cardiovascular Diseases.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 436
- 试验地点
- 1
- 主要终点
- CSA-AKI and severe CSA-AKI
研究概览
简要总结
brief summary：The goal of this observational study is to evaluate the value of perioperative transcutaneous fluorescence glomerular filtration rate (GFR) monitoring for the early prediction and diagnosis of cardiac surgery-associated acute kidney injury (CSA-AKI) and contrast-associated acute kidney injury(CA-AKI) in adult patients. The main questions it aims to answer are: Can perioperative GFR or peri-contast trajectories measured by a transcutaneous fluorescence monitoring system predict the development of CSA-AKI or CA-AKI before conventional diagnostic criteria are met? What changes in perioperative or peri-contast GFR trajectories are associated with the occurrence and severity of CSA-AKI or CA-AKI? Participants scheduled for cardiovascular surgery or contast-enhanced CT scan or PCI will undergo continuous perioperative transcutaneous GFR monitoring following intravenous administration of a fluorescent tracer. Clinical characteristics, perioperative or peri-contast hemodynamic data, laboratory measurements, imaging findings, and postoperative or post-contast outcomes will be collected to evaluate the predictive and diagnostic performance of perioperative or peri-contrast GFR trajectories for CSA-AKI or PC-AKI.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years old;
- •Specific inclusion criteria for the cohort:
- •GFR trajectory characterization after cardiovascular surgery or Iodine contrast agent exposure: Patients scheduled for elective cardiovascular surgery or interventional cardiovascular surgery or CTA; ② GFR trajectory characterization of AKI: Patients with confirmed CSA-AKI or contrast-associated acute kidney injury (CA-AKI).
排除标准
- •Received renal replacement therapy before surgery or before contrast imaging, including kidney transplantation and regular dialysis;
- •Serum creatinine > 353 μmol/L before surgery or before contrast imaging;
- •Patients with AKI who did not recover before surgery or before contrast imaging;
- •Patients with malignant tumors.
研究组 & 干预措施
Determination of GFR trajectories after cardiovascular surgery or contrast agent exposure
Perform GFR testing on patients who are scheduled for cardiovascular surgery or who are going to receive contrast agents to determine the GFR trajectory after the cardiovascular surgery or the contrast agent exposure.
The determination of the GFR trajectory for CSA-AKI or CA-AKI
Perform GFR testing on patients with AKI related to cardiovascular surgery or contrast agents to determine their trajectory
Perioperative changes in GFR for the early prediction and diagnosis of CSA-AKI
Incorporate adult patients who meet the inclusion and exclusion criteria and are scheduled for cardiovascular surgery, and monitor their perioperative changes in GFR through GFR testing to achieve early prediction and diagnosis of CSA-AKI.
结局指标
主要结局
CSA-AKI and severe CSA-AKI
时间窗: Within 7 days after cardiovascular surgery
Incidence of cardiac surgery-associated acute kidney injury (CSA-AKI), defined according to the KDIGO criteria based on postoperative changes in serum creatinine and incidence of severe cardiac surgery-associated acute kidney injury, defined as KDIGO Stage 2 or Stage 3 acute kidney injury.
Contrast-associated acute kidney injury
时间窗: Within 72 hours after contrast media administration
Incidence of contrast-associated acute kidney injury, defined according to the Kidney Disease: Improving Global Outcomes (KDIGO) criteria based on changes in serum creatinine following contrast media administration.
次要结局
- All-cause and Cardiovascular Mortality(Within 1 year after cardiac surgery or contrast media administration)
- Severe Acute Kidney Injury(Within 7 days after cardiac surgery or within 72 hours after contrast media administration)
- Progression of AKI Stage(From AKI diagnosis to 7 days after cardiac surgery or 72 hours after contrast media administration)
- Acute Kidney Disease (AKD)(From 7 days to 90 days after AKI onset)
- Renal Replacement Therapy (RRT)(Within 90 days after cardiac surgery or contrast media administration)
- Major Adverse Cardiovascular Events (MACE)(Within 1 year after cardiac surgery or contrast media administration)
- New-onset Chronic Kidney Disease or CKD Progression(Within 1 year after cardiac surgery or contrast media administration)
- Rate of Decline in Glomerular Filtration Rate(From baseline to 1 year after cardiac surgery or contrast media administration)
- Change in Glomerular Filtration Rate(From baseline to 90 days after cardiac surgery or contrast media administration)