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Management Practices and the Risk of Infection Following Cardiac Surgery

2014年4月4日 更新者：Icahn School of Medicine at Mount Sinai
The purpose of the study is to determine the best ways to prevent infections after heart surgery. Participation in the study will last at most 3 months after heart surgery. The study will only collect information about the care patients receive during the planned surgery. No new testing or procedures will be done. Patients will receive only the tests or procedures the doctor already has planned. This kind of study is an observational study, because all that is planned to do is observe the care patients receive and how well they do during treatment. The information collected should help to improve the quality of surgical care in the future.

研究概览

地位

完全的

条件

详细说明

Hospital-acquired infections represent the main non-cardiac complication after heart surgery. They are associated with substantial morbidity and higher mortality, as they often require prolonged hospitalization and additional surgery. The proportion of cardiac surgery patients at high-risk for infection is increasing because of the increased prevalence of co-morbid conditions such as obesity and diabetes mellitus in the general (and especially the elderly) population.

In addition to increased morbidity and mortality, infectious complications also result in greater economic burden. A past study estimated that the incremental cost of treating Medicare beneficiaries who suffered from septicemia after coronary artery bypass grafting (CABG) to be $59,204. These patients stayed in the hospital 21.3 days longer than those who did not experience any serious adverse events. Of great relevance to treating hospitals, the Centers for Medicare and Medicaid Services (CMS) announced in the fall of 2007 that they would no longer pay for care related to preventable complications. CMS specifically mentioned excluding reimbursements for mediastinitis after CABG, and catheter associated infections. Thus, there is a crucial need to identify variables that mitigate infections post cardiac surgery and to develop effective preventative treatment strategies.

Prior studies have examined the relationship between patient baseline (preoperative) characteristics (e.g., co-morbid conditions) and hospital-acquired infections post cardiac surgery. The STS database, for example, has led to the identification of predictive factors of post-operative CABG infections. Much of the variations in outcomes seen at different institutions, however, cannot be explained by differences in preoperative patient characteristics alone. How care is delivered also plays an essential role in determining infection rates and is therefore likely to explain some of the differences in these rates observed at different institutions. The literature has not sufficiently examined the relationship between treatment/management practices (e.g., line management, ventilator management, etc) and postoperative infection risk. In this study we seek to better understand management practices that put patients at high risk for infections post-cardiac surgery.

研究类型

观察性的

注册 (实际的)

5158

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 加拿大
    • Quebec
      • Montreal、Quebec、加拿大、H1T 1C8
        • Montreal Heart Institute
  • 美国
    • Georgia
      • Atlanta、Georgia、美国、30383
        • Emory University
    • Maryland
      • Bethesda、Maryland、美国、20892
        • NIH Heart Center at Suburban Hospital
    • New York
      • Bronx、New York、美国、10467
        • Montefiore Einstein Heart Center
      • New York、New York、美国、10032
        • Columbia University Medical Center
    • North Carolina
      • Durham、North Carolina、美国、27710
        • Duke University
      • Greenville、North Carolina、美国、27834
        • East Carolina Heart Institute
    • Ohio
      • Cleveland、Ohio、美国、44195
        • Cleveland Clinic Foundation
    • Pennsylvania
      • Philadelphia、Pennsylvania、美国、19104
        • University of Pennsylvania
    • Virginia
      • Charlottesville、Virginia、美国、22908
        • University of Virginia

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

取样方法

非概率样本

研究人群

All patients undergoing cardiac surgical interventions at the 10 CT Surgery Network institutions

描述

Inclusion Criteria:

  • Clinical indication for cardiac surgical interventions
  • Age ≥ 18 years

Exclusion Criteria:

  • Active systemic infection at the time of enrollment

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

队列和干预

团体/队列
Patients undergoing cardiac surgery
The patient population for this study consists of all patients undergoing cardiac surgical interventions. All patients who meet the eligibility criteria may be included in the study regardless of gender, race or ethnicity.

研究衡量的是什么？

主要结果指标

结果测量
大体时间
The primary endpoint will be major infection within 60 days of index cardiac surgical intervention.
大体时间：60 Days
60 Days

次要结果测量

结果测量
大体时间
Major infection after surgery during the operative admission or within 30 days after discharge when associated with readmission.
大体时间：30 Days
30 Days
Other infections within 60 days of index cardiac surgical intervention; Superficial incisional surgical site infection (primary/secondary); Symptomatic urinary tract infection; Asymptomatic bacteriuria
大体时间：60 Days
60 Days
Non-infection adverse events within 60 days of index cardiac surgical intervention; Neurologic Dysfunction; Transient ischemic attack; cerebrovascular accident (ischemic or hemorrhagic stroke); Myocardial infarction
大体时间：60 Days
60 Days
Re-operation within 60 days of index cardiac surgical intervention
大体时间：60 Days
60 Days
Survival, All-cause mortality, Hospitalizations, Economic Measures
大体时间：60 Days
60 Days

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Icahn School of Medicine at Mount Sinai

合作者

National Heart, Lung, and Blood Institute (NHLBI)
Canadian Institutes of Health Research (CIHR)
National Institute of Neurological Disorders and Stroke (NINDS)

调查人员

  • 学习椅：Timothy Gardner, MD、Christiana Care Health Services
  • 学习椅：Patrick O'Gara, MD、Brigham and Women's Hospital
  • 首席研究员：Annetine Gelijns, Ph.D.、Icahn School of Medicine at Mount Sinai

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

有用的网址

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2010年1月1日

初级完成 (实际的)

2011年9月1日

研究完成 (实际的)

2013年3月1日

研究注册日期

首次提交

2010年3月17日

首先提交符合 QC 标准的

2010年3月17日

首次发布 (估计)

2010年3月18日

研究记录更新

最后更新发布 (估计)

2014年4月8日

上次提交的符合 QC 标准的更新

2014年4月4日

最后验证

2014年4月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • GCO 08-1078-00005
  • 5U01HL088942 (美国 NIH 拨款/合同)
  • 5U1HL088942-02
  • 694 (其他标识符：Ct Surgery Network Research Group)

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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