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PREMIUM Registry: PRognostic HEModynamIc Profiling in the AcUtely Ill EMergency Department Patient (PREMIUM)

2015年8月3日更新者：Richard M Nowak、Henry Ford Health System

PROGNOSTIC HEMODYNAMIC PROFILING IN THE ACUTELY ILL EMERGENCY DEPARTMENT PATIENT

This multinational registry (3 USA, 2 European centers) will capture in the ED continuous non invasive hemodynamic monitoring (using Nexfin finger cuff technology) of patients presenting with acute heart failure, stroke syndromes and systemic infection. Patients will be observed after their Emergency Department (ED) disposition to determine clinical outcomes (length of stay in the hospital, the development of any organ dysfunction, mortality and need for unscheduled medical care within the ensuing 30 days). It is anticipated that specific ED hemodynamic profiles will be predictive of better clinical outcomes than others. This information will provide the outcome data needed to design future therapeutic trials that will evaluate the effect of ED hemodynamic manipulations on overall patient management and outcomes.

研究概览

地位

完全的

条件

详细说明

The PREMIUM Registry is a multinational, prospective, observational convenience study of the ED hemodynamic profiles of patients presenting with acute CHF, stroke and systemic infections and their potential relationship with patient outcomes. Continuous hemodynamics will be measured by noninvasive means using the Nexfin device and outcomes (in hospital length of stay, the interval development of organ dysfunction and mortality or the need for unscheduled medical care within the ensuing 30 days) will be captured within the registry.

The treating ED physicians will be blinded to the hemodynamic monitoring and there will be no modification of the standard care that each patient receives. Hospital charts will be reviewed and patients/family members will be additionally called at 30 days after the hospital visit in order to collect any additional outcome data.

研究类型

观察性的

注册 (实际的)

514

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

意大利
- - Rome、意大利、00189
    - University LaSapienza Rome Sant'Andrea Hospital
美国
- Michigan
  - Detroit、Michigan、美国、48202
    - Henry Ford Hospital
  - Detroit、Michigan、美国、48201
    - Detroit Receiving Hospital/Wayne State University
荷兰
- - Amsterdam、荷兰
    - VU University Medical Centre

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

是的

有资格学习的性别

全部

取样方法

概率样本

研究人群

Potential subjects will be screened and enrolled from the Emergency Department

描述

Inclusion Criteria:

General Inclusion Criteria

18 years of age or older
Able to provide informed consent
No initiated therapy since arrival to the ED
Must be enrolled within 4 hours of arrival to the ED

Inclusion Criteria for Acute CHF

Recurrent or worsening (within 3 days) shortness of breath as the primary presenting ED complaint
Initial treating ED physician impression that the worsening dyspnea is most likely caused by decompensated CHF
Known history of physician diagnosed CHF
Natriuretic peptide (BNP, MR-pro ANP, NT pro BNP) level will be ordered by the treating physician as part of the patient's work up

Inclusion Criteria for Acute Stroke Syndrome

Onset of abnormal neurological symptoms consistent with possible stroke, within the prior 24 hours, as the primary ED complaint
Initial treating ED physician impression that the abnormal neurological symptoms/signs are most likely caused by an acute stroke syndrome
Non contrast head CT will be ordered by the treating physician as part of the patient's work up

Inclusion Criteria for Acute Systemic Infection

Any combinations of acute (within 3 days) symptoms and signs that the treating ED physician, after initial history and physical examination, attributes to a systemic infection
Blood cultures and/or a blood lactate will be ordered by the treating physician as part of the patient's work up

Exclusion Criteria:

General Exclusion Criteria

ESRD requiring hemo or peritoneal dialysis
Suspected pregnancy
Not able to be followed up in 30 days
Patients with "comfort only" DNR status
Patients with known STEMI
Excessive agitation
Transferred from another treating facility
Known aortic valve disease
On continuous IV home infusions (such as milrinone, primacor)
Known Left Ventricular Assist device (LVAD)
Known prior enrollment in this study
In current therapeutic Investigational study

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

团体/队列数

队列和干预

团体/队列
Acute CHF Recurrent or worsening (within 3 days) shortness of breath as the primary presenting ED complaint Initial treating ED physician impression that the worsening dyspnea is most likely caused by decompensated CHF Known history of physician diagnosed CHF Natriuretic peptide (BNP, MR-pro ANP, NT pro BNP) level will be ordered by the treating physician as part of the patient's work up
Acute Stroke Syndrome Onset of abnormal neurological symptoms consistent with possible stroke, within the prior 24 hours, as the primary ED complaint Initial treating ED physician impression that the abnormal neurological symptoms/signs are most likely caused by an acute stroke syndrome Non contrast head CT will be ordered by the treating physician as part of the patient's work up
Acute Systemic Infection Any combinations of acute (within 3 days) symptoms and signs that the treating ED physician, after initial history and physical examination, attributes to a systemic infection Blood cultures and/or a blood lactate will be ordered by the treating physician as part of the patient's work up

研究衡量的是什么？

主要结果指标

结果测量	措施说明	大体时间
Hemodynamic profile (CO, SVR, SV, DP/DT and Indexed values) 大体时间：4 hours	Describe the 4 hour continuous ED hemodynamic profiles (CO, SVR, SV, DP/DT and Indexed values)of patients treated under current clinical standards with acute CHF, stroke syndromes and systemic infection.	4 hours

次要结果测量

结果测量	措施说明	大体时间
Hemodynamic Profiles in acute CHF, stroke, and systemic infection 大体时间：4 Hours	Describe the hemodynamic profiles within existing risk stratification groupings currently used for these 3 disease states. These include but are not limited to BNP and troponin values for acute CHF, infarct/bleed size in acute stroke syndromes, and WBC and procalcitonin (where applicable) and blood lactate levels in systemic infections. Determine which hemodynamic profiles measured in the ED predict clinical outcomes (mortality, end organ dysfunction, and length of stay)	4 Hours

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

Henry Ford Health System

合作者

Edwards Lifesciences

BMEYE BV the Netherlands

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9月1日

初级完成 (实际的)

2012年9月1日

研究完成 (实际的)

2012年9月1日

研究注册日期

首次提交

2010年9月14日

首先提交符合 QC 标准的

2010年9月22日

首次发布 (估计)

2010年9月23日

研究记录更新

最后更新发布 (估计)

2015年8月4日

上次提交的符合 QC 标准的更新

2015年8月3日

最后验证

2015年8月1日