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临床试验/NCT04962412
NCT04962412已完成不适用

Predicting Poor Outcomes of Cardiac Surgery-Associated Acute Kidney Injury Using Novel Biomarkers

Guowei Tu2 个研究点 分布在 1 个国家目标入组 3,152 人开始时间: 2021年7月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
3,152
试验地点
2
主要终点
AKI progression

研究概览

简要总结

The aim of this study was to identify and validate novel biomarkers including functional tests for detecting AKI, AKI progression and other poor outcomes.

详细描述

Cardiac surgery-associated acute kidney injury (CSA-AKI) is the second most common type of AKI after septic AKI and is associated with increased mortality and morbidity. The progression of AKI with multiple organ failure can result in poor outcomes. Several novel biomarkers for earlier detection of AKI, discrimination of etiologies, and prediction of outcomes were developed. However, the availability of these novel biomarkers may be limited by its expense or reimbursement issues in different countries. In present study, we conduct a large cohort to identify and validate novel biomarkers including functional tests for detecting AKI, AKI progression and other poor outcomes.

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 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients undergoing cardiac surgery were prospectively screened, and those who developed AKI within 48 hours post-surgery were included in the study.

排除标准

  • History of End Stage Renal Disease or on Dialysis;
  • prior kidney transplantation;
  • patients with a DNR order;
  • patients without written informed consent;
  • pregnancy;
  • moribund patients with expected death within 24 h or whose survival to 28 days was unlikely due to an uncontrollable comorbidity (i.e., end-stage liver or heart disease, untreatable malignancy)

结局指标

主要结局

AKI progression

时间窗: 7 days

worsening of KDIGO stage within 1 week (progressing from stage 1 to either stage 2 or stage 3, or from stage 2 to stage 3). Patients diagnosed with progressive or persisting stage 3 AKI (stage 3 AKI for \>3 consecutive days) were classified as having AKI progression. If patients who presented with stage 3 AKI but not requiring RRT subsequently required dialysis or developing persist severe AKI or death within 7 days, this was considered progression.

次要结局

  • AKI occurrence at 7 days(7 days)
  • Persistent AKI(90 days)
  • Mortality(365 days)
  • AKI progression to stage 3(7 days)
  • AKI occurrence at 3 days(3 days)
  • Length of stay in the ICU(90 days)
  • Receipt of renal replacement treatment(365 days)
  • Major adverse kidney events(365 days)
  • Persist severe AKI(90 days)
  • Length of stay in the hospital(90 days)

研究者

发起方
Guowei Tu
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Guowei Tu

Scientific Secretary for Department of Critical Care Medcine

Shanghai Zhongshan Hospital

研究点 (2)

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