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临床试验/NCT01173393
NCT01173393已完成3 期

The RINSE Trial: Rapid Infusion of Cold Saline During CPR for Patients With Cardiac Arrest

Ambulance Victoria1 个研究点 分布在 1 个国家目标入组 1,220 人开始时间: 2010年7月最近更新:
适应症

试验速览

阶段
3 期
状态
已完成
入组人数
1,220
试验地点
1
主要终点
Survival at hospital discharge

研究概览

简要总结

That paramedic core cooling during CPR using a rapid infusion of ice-cold (4 degrees C) large-volume (30mL/kg) normal saline improves outcome at hospital discharge compared with standard care in patients with out-of-hospital cardiac arrest.

详细描述

INTRODUCTION:

Pre-hospital cardiac arrest is common and associated with a poor prognosis and only about 8% of patients have a good outcome. For patients who are initially successfully resuscitated by ambulance paramedics and transported to hospital, there is considerable mortality and morbidity. This is largely due to the anoxic brain injury sustained during the cardiac arrest.

One current therapy for the severe anoxic brain injury following out-of-hospital cardiac arrest is therapeutic hypothermia (TH) induced after resuscitation. This treatment was shown to improve outcomes in two clinical trials. The International Liaison Committee on Resuscitation now recommend TH (33°C for 12-24 hours) for patients who remain comatose after resuscitation from cardiac arrest.

However, the optimal timing of TH is still uncertain. The above clinical studies used surface cooling and this delayed TH until after arrival at the hospital. On the other hand, laboratory data has suggested that there is significantly decreased neurological injury if cooling is initiated during CPR.

The current ideal technique for induction of TH during CPR is a rapid intravenous infusion of a large volume of ice-cold fluid. This technique has become established as the cooling method of choice in the pre-hospital setting, the Emergency Department (14) and the Intensive Care Unit.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
Single (Participant)

入排标准

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

入选标准

  • Patients in cardiac arrest on arrival of paramedics and who:
  • Are adults > 18 years/ are in cardiac arrest (pulseless) on arrival of paramedics

排除标准

  • Patients who are:
  • In cardiac arrest following trauma or suspected intra-cranial bleeding/ obviously pregnant/ Dependant on others for activities of daily living (ie any assistance with activities of daily living, in supported care or nursing home residents) or have pre-existing significant neurological injury,Likely to be "Not for Resuscitation" and/or admission to the Intensive Care Unit because of terminal disease or advanced age, Patients who are hypothermic already and are confirmed to be on temperature measurement/ in-hospital cardiac arrest.

结局指标

主要结局

Survival at hospital discharge

时间窗: At hospital discharge or 28 days

次要结局

  • Quality of Life(6 months)
  • Return of Spontaneous Circulation(within 60 minutes of arrest)

研究者

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

Stephen Bernard

Medical Advisor

Ambulance Victoria

研究点 (1)

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