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临床试验/NCT01419106
NCT01419106已完成不适用

SHoC-ED: Sonography in Hypotension and Cardiac Arrest in the Emergency Department.

Horizon Health Network9 个研究点 分布在 2 个国家目标入组 273 人开始时间: 2011年8月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
273
试验地点
9
主要终点
Patient Mortality Rates (7-day, 30 Day or Hospital Discharge)

研究概览

简要总结

This study is designed to determine if there is any relationship between performing an abdominal ultrasound on patients who present with hypotension and their clinical outcomes (as measured by 7, 30 day and discharge mortality).

详细描述

STRUCTURED RESEARCH ABSTRACT

Introduction

Patients who present to the ED (emergency department) with undifferentiated, non-trauma associated hypotension are often affected by conditions with a prognosis largely dependent on the time taken from presentation to correct diagnosis and intervention. The ACES protocol (Abdominal and Cardiothoracic Evaluation with Sonography in Shock) provides a rapid focused ultrasound protocol for making or refining diagnoses in patients who present to the ED with this type of hypotension. This will be the first study to compare the clinical outcomes of patients who are assessed with the ACES protocol as part of their initial workup to those of patients who are assessed without any intervention by ultrasound. The goal of this study is to determine if ACES enhances the patient's clinical outcomes, as measured by: 1) Time to restoration (or improvement) of CVS (cardiovascular system) parameters, 2) Rate of normalization of acid-base balance, as well as venous lactate 3) Significant change in diagnosis or recommended intervention 4) Frequency of unexpected diagnosis, and 5) Patient 7 and 30-day, and discharge mortality rate.

Methods

SHoC-ED 1 is a stratified randomized control trial that will run in multiple centers across Canada and internationally. The data will be stratified in that each center involved will recruit equal amounts of control and intervention patients. While different centers will recruit different numbers of participants, each individual center will recruit near-equal amounts for each arm of the study.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
19 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 19 years of age or older
  • Systolic Blood Pressure under 100 OR Systolic BP under pulse (up to 120)

排除标准

  • Patients known to be pregnant at time of presentation
  • Necessity of CPR or other advanced life support interventions before enrolment
  • History of significant trauma in past 24 hours
  • A 12 lead diagnostic of acute myocardial infarction
  • Mechanism of shock is clear (i.e. not undifferentiated shock)
  • Previously known diagnosis from other hospital
  • Vagal episode (as cause of hypotension)
  • Low blood pressure not actually being pathologic hypotension (Normal Variant or other)

结局指标

主要结局

Patient Mortality Rates (7-day, 30 Day or Hospital Discharge)

时间窗: 7-day, 30 Day or Hospital Discharge

Determine the proportion of patients living at 7-day, 30 Day or Hospital Discharge

次要结局

  • Unexpected change in diagnosis(First hour)
  • Time taken to appropriate intervention(Within 8 hours)

研究者

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

Paul Atkinson

Dr. Paul Atkinson, Professor, Department of Emergency Medicine

Horizon Health Network

研究点 (9)

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