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临床试验/NCT05248451
NCT05248451Unknown不适用

The Impact of Chronic Kidney Disease on Risk of Myocardial Injury After Non Cardiac Surgery (MINS). A Retrospective Chart Review.

University of British Columbia1 个研究点 分布在 1 个国家目标入组 600 人开始时间: 2021年6月22日最近更新:
适应症

试验速览

阶段
不适用
入组人数
600
试验地点
1
主要终点
Myocardial injury after non cardiac surgery (MINS)

研究概览

简要总结

Investigators will conduct a retrospective chart review, examining the impact of chronic kidney disease on risk of myocardial injury after non cardiac surgery (MINS). The objective of this study is to examine interactions between preoperative Estimated Glomerular Filtration Rate (eGFR) and the association between preoperative N-Terminal Pro B-Type Natriuretic Peptide (NT-proBNP) and post operative cardiac events in patients undergoing major non cardiac surgery.

详细描述

In recent years some authors have shown a correlation between increased post operative troponin and increased 30 day mortality in patients with kidney disease that mirrors the known correlation in those with normal renal function. In patients undergoing non cardiac surgery, Walsh et al demonstrated a 4 to 6 fold increased risk of death associated with elevated post operative troponin in patients with reduced (<60 ml/min, but >30ml/min) preoperative estimated glomerular filtration rate (eGFR). A second, more recent study by Liem et al, also found post operative troponin elevations were associated with higher morbidity and mortality risk in patients with chronic kidney disease undergoing non cardiac surgery. Investigators aim to build upon the findings of these authors by examining the relationship between pre operative eGFR, post operative troponin and risk of post operative cardiac events in patients undergoing non cardiac surgery at St Paul's hospital. Investigators will conduct a retrospective chart review of electronic records for all patients undergoing non cardiac, inpatient surgery at St Paul's Hospital from June 1, 2020 to December 31, 2021). Investigators will include all patients for whom preoperative eGFR values are available, and patients on chronic dialysis. Patients are to be stratified by preoperative eGFR and primary outcomes compared between patients with normal vs abnormal preoperative eGFR. Primary outcomes to be reviewed are myocardial injury after non cardiac surgery (MINS) and troponin elevations.

研究设计

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

入排标准

性别
All
接受健康志愿者

入选标准

  • Patients undergoing non cardiac surgery, at St Paul's Hospital, during the period spanning June 1 2020 to November 30 2020
  • Preoperative eGFR data is available, or chronic dialysis status is known (these patients will not reliably have eGFR measured, and it is not relevant)
  • Inpatient surgeries (elective, urgent, and emergent)

排除标准

  • Patients undergoing cardiac surgery.
  • Patients undergoing day surgery
  • Patients for whom Estimated Glomerular Filtration Rate (eGFR) results are not available

结局指标

主要结局

Myocardial injury after non cardiac surgery (MINS)

时间窗: Within 30 days post-operatively

Myocardial injury after non-cardiac surgery (MINS), based on the American Heart Association (AHA) definitions

Troponin Elevation

时间窗: Postoperative day 1 - 3

Post-operative high sensitivity Troponin T (hs-TnT) of 20 ng/L to 65 ng/L with an absolute increase of at least 5 ng/L or any concentration \> 65 ng/L

次要结局

  • Cancellations of elective surgical cases for non-clinical reasons(From June 1, 2020 to December 31, 2021)

研究者

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

Su-Yin MacDonell

Clinical Assistant Professor

University of British Columbia

研究点 (1)

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