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临床试验/NCT03325452
NCT03325452已完成不适用

A Pilot Study Evaluating the PROgnostic Contribution of Venous Lactate for the Recovery of Spontaneous Cardiac Activity, Following an Extra-hospital Cardiac Arrest "PROLAC Study"

Centre Hospitalier Universitaire de Nice1 个研究点 分布在 1 个国家目标入组 77 人开始时间: 2017年12月19日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
77
试验地点
1
主要终点
venous lactate

研究概览

简要总结

Incidence of non-hospital cardio-respiratory arrest (ACR) in France is around 40 000 cases per year, with mortality remaining very high, with 75% of patients dying before arrival in hospital. The investigators know some validated predictive factors for recovery of spontaneous cardiac activity (RACS) such as age, no flow (time between ACR and onset of CPR), type of initial electrical activity (FV, TVSP), or the value of CO2 expired.

However, the use of these prognostic criteria in the conduct of CPR maneuvering is in practice limited. Lactate is now a well-known prognostic biological marker used in many pathological conditions such as shock states or the severe traumatized patient. Some data have also demonstrated the prognostic value of lactate on morbidity and mortality after ACR after resumption of spontaneous cardiac activity.

The hypothesis of our study is that the evaluation of the initial lactate in the early cardiopulmonary resuscitation could be a prognostic factor of RACS.

详细描述

Incidence of non-hospital cardio-respiratory arrest (ACR) in France is around 40 000 cases per year, with mortality remaining very high, with 75% of patients dying before arrival in hospital. This disease is associated with a high morbidity since today the investigator find less than 5% survival at 1 year with a favorable neurological outcome.

The recommendations of ILCOR 2015 underline in this case the importance of implementing therapeutic measures in the extra-hospital step. Indeed, the survival of ACR patients will depend mainly on the alert delay at the UAS center, the immediate implementation of cardiopulmonary resuscitation (CPR) maneuvers and the early delivery of external electric shock.

The investigators know some validated predictive factors for recovery of spontaneous cardiac activity (RACS) such as age, no flow (time between ACR and onset of CPR), type of initial electrical activity (FV, TVSP), or the value of CO2 expired.

However, the use of these prognostic criteria in the conduct of CPR maneuvering is in practice limited.

Today, none of these prognostic factors allow us to adapt the cardiopulmonary resuscitation maneuvers to the different clinical situations, and it is recognized that a CPR must be carried out for 30 minutes in all cases.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

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

  • Male >18 years of age
  • Women over 50 years of age (ie, with amenorrhea> 1 year).
  • Victim of non-traumatic cardiopulmonary arrest.
  • Medical decision to start or continue cardiopulmonary resuscitation.
  • Consent of family or person of trust if present (and patient as soon as possible).
  • patient affiliated to the social security

排除标准

  • Refusal of family or trusted person to participate in the study
  • Pre-paramedical management with use of adrenaline and protection of the airways
  • Use of the intraosseous line from the outset or after failure of the peripheral venous pathway by the medical team outside hospital
  • Minor Patient
  • vulnerable patient under legal protection (guardianship or curators)

结局指标

主要结局

venous lactate

时间窗: at baseline

The main evaluation criteria will be the value of the venous lactate that was measured during insertion of the peripheral venous line at the arrival of the medical team (= T0) in patients in cardiac arrest

次要结局

  • The kinetics of capillary lactate(at time = 30 minutes)
  • The no-flow(at baseline)
  • Initial value of capillary lactate(at baseline)
  • The kinetics of capillary lactate(at time = 10 minutes)
  • The kinetics of capillary lactate(at time = 20 minutes)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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