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临床试验/NCT05222074
NCT05222074已完成不适用

Venous Congestion Rather Than Intraoperative Hypotension is Associated With Acute Adverse Kidney Events After Cardiac Surgery

Nanjing First Hospital, Nanjing Medical University1 个研究点 分布在 1 个国家目标入组 5,127 人开始时间: 2016年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
5,127
试验地点
1
主要终点
AKD

研究概览

简要总结

This study was aimed to explore the effect of intraoperative venous congestion and intraoperative hypotension (IOH) on acute adverse kidney events, defined as acute kidney injury (AKI) and acute kidney disease (AKD), after cardiac surgery

详细描述

Venous congestion and IOH were primary exposures and quantified as area under the curve (AUC) of central venous pressure ≥12, 16 or 20 mmHg or mean arterial pressure ≤55, 65, 75 mmHg. The primary outcome was AKI or AKD defined as renal dysfunction persisting > 7 days after surgery. Multivariable logistic regression and Cox proportional hazard models were used to determine the association between intraoperative venous congestion/hypotension and postoperative acute adverse kidney events, respectively, adjusted for relevant confounding factors and multiple comparisons.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

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 aged 18 years and older,
  • Patients underwent cardiac surgery (coronary artery bypass grafting, heart valve surgery, heart transplant or surgical excision of intracardiac myxoma)
  • Patients receiving invasive intraoperative BP monitoring during surgery
  • Patients underwent cardiopulmonary bypass (CPB) during surgery

排除标准

  • Pre-existing renal insufficiency defined by presence of abnormal preoperative serum creatinine ≥ 133 μmol/L and/or preoperative diagnosis of renal insufficiency within 6 months'preoperative period.
  • Patients with preoperative dialysis dependence within 60 days before the index surgical procedure,
  • Surgical duration less than 30 minutes
  • Surgery on the aorta
  • Insufficient hemodynamic and laboratory data for outcomes and/or exposure ascertainment

结局指标

主要结局

AKD

时间窗: 8 to 90 days post operation

Acute Kidney Disease, which was defined according to the criteria recommended by the Acute Disease Quality Initiative (ADQI) workgroup.4 AKI was quantified within the 7 days' postoperative period, while AKD was defined as serum creatinine value elevated to 1.5 times the baseline value between 8- and 90-day post-operation period.

CSA-AKI

时间窗: 7 days post operation

Cardiovascular surgery associated acute kidney injury. AKI was defined using the Kidney Disease: Improving Global Outcome (KDIGO) Clinical Practice Guideline for Acute Kidney Injury as an absolute increase in serum creatinine of ≥ 26 μmol/L within 48 hours or an increase in serum creatinine beyond 1.5 times the baseline value within 7 days

次要结局

  • inpatient mortality(30 days after inhospital)
  • Incidence of AKD of stage 2 and above(8 to 90 days post operation)
  • length of hospital stay(from the end of operation to the discharge from hospital, up to 90 days.)
  • RRT initiation(from the end of operation to the discharge from hospital, up to 90 days.)
  • value of eGFR(7 days after operation)
  • ICU length of stay(from the end of operation to the discharge from ICU, up to 90 days.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

HONG LIANG

Doctor

Nanjing First Hospital, Nanjing Medical University

研究点 (1)

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