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临床试验/NCT02648061
NCT02648061已完成不适用

Transitions Between Clinical Circulatory States After Out-of-hospital Cardiac Arrest

Norwegian University of Science and Technology1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2016年1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
50
试验地点
1
主要终点
Time in clinical circulatory state (stable, unstable, severe unstable)

研究概览

简要总结

Extensive research exists for cardio-pulmonary resuscitation (CPR) and the chance of successful return of spontaneous circulation (ROSC) is improved. Unfortunately, the overall prognosis after ROSC has not improved much and the in-hospital mortality is still reported to be 50 to 70 %. The "post-resuscitation disease" is now called the "post-cardiac arrest syndrome" (PCAS) and comprises 1) brain injury, 2) myocardial dysfunction and 3) systemic ischemia and reperfusion.

Treatment of patients after cardiac arrest has often followed guidelines that were primarily developed for treatment of septic shock. It is still uncertain whether this is the optimal way to deliver circulatory support after cardiac arrest.

There is a lack of studies assessing the relationship between the inflammatory response measured by inflammatory biomarkers and circulatory failure in PCAS.

In this study a detailed description will be given of the clinical trajectory of the circulation and the inflammatory response during the first 5 days after cardiac arrest, and it will be investigated whether patterns of circulatory and inflammatory response may be predictive of deterioration of clinical state.

详细描述

This study will obtain longitudinally advanced hemodynamic observations with high resolution during the acute phase of post cardiac arrest syndrome (PCAS), and analyze the details in clinical transitions related to circulatory failure. The study will also analyze the relationship between inflammatory biomarkers and circulatory failure in PCAS and kinetics of hemodynamics associated with standard interventions in the intensive care unit (ICU).

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

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

  • Return of spontaneous circulation (ROSC) after out-of-hospital cardiac arrest (OHCA)
  • Admitted to Coronary Care Unit (CCU) or Intensive Care Unit (ICU), St. Olav's University Hospital

排除标准

  • Sepsis within 24 hours before cardiac arrest
  • Pregnancy
  • Decision of withdrawal or withholding of life prolonging therapy (i.e. due to advanced malignancy)

结局指标

主要结局

Time in clinical circulatory state (stable, unstable, severe unstable)

时间窗: 5 days

These clinical circulatory states are defined as follows: 1) Stable circulation (Mean blood pressure \> 65 mmHg, heart rate 51-100, lactate serum concentrations \< 2 mmol/l, ScvO2 \> 65, fluid administration \< 0.5 l/h, norepinephrine dose \< 0.1 microgram/kg/min, no other vasoactive drugs. 2) Unstable circulation (mean blood pressure 45-64 mmHg , heart rate 41-50, 101-130, lactate serum concentrations 2-4 mmol/l, ScvO2 \> 50-64, fluid administration 0.5-1,9 l/h, norepinephrine dose 0.1-0.29 microgram/kg/min, Dobutamin \> 10 microgram/kg/min, no other vasoactive drugs) 3) Severe unstable circulation (mean blood pressure \< 45 mmHg , heart rate \< 40, \> 130, lactate serum concentrations \>4 mmol/l, ScvO2 \< 50, fluid administration \> 2.0 l/h, norepinephrine dose 0.3 or above microgram/kg/min, dobutamin \> 10 microgram/kg/min, other vasoactive drugs, use of aortic balloon pump).

次要结局

  • Interleukin-6 in relation to dose of Norepinephrine used to correct vasoplegia after cardiac arrest(5 days)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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