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临床试验/CTRI/2024/07/070921
CTRI/2024/07/070921已完成不适用

NeuRological outcomE of patients after cardiac arreST in neurOcritical care unit: The RESTORE Study

All India Institute of medical sciences New Delhi1 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2024年7月26日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
75
试验地点
1
主要终点
1.Neurological outcome assessed using Glasgow outcome scale extended at 3 and 6 months

研究概览

简要总结

Cardiac arrest is a major health problem, with a yearly incidence of about 50-110 per 100000 people worldwide.  The brain is prone to injury even during short periods of limited blood flow.  Thus the most frequent cause of morbidity and mortality after cardiac arrest is neurologic injury. This becomes more significant in neurocritical care ICU where there is already patients suffering from brain insult.  Hypoxia and ischemia sustained by the brain during arrest causes an injury cascade that may include excitotoxicity, disrupted calcium homeostasis, free radical formation and pathologic protease pathways,which are associated with cell death and neurological dysfunction. A majority of patients who are resuscitated after cardiac arrest and survive intensive care; have some neurological impairments that can range from mild cognitive deficit to coma.

Sudden cardiac arrest accounts for 15-20 % of all the deaths in the general population and timely cardio-pulmonary resuscitation (CPR) improves survival rate by three to four times. In indian studies in-hospital cardiac arrest survival rate ranges from 6.9 to 27.5%.

There is no definite consensus on what represents a poor neurological outcome after a cardiac arrest. The timing of neurological outcome assessment also affects its measured values, since in initially comatose cardiac arrest survivor’s neurological status can improve for upto 6 months. Optimal time for assessment of neurological outcome after cardiac arrest have yet to be established.

Cardiac arrest is a catastrophic event with higher morbidity and mortality rate. The neurological injury post cardiac arrest is more devastating to the patient as well as to the family. The vast majority of persons successfully resuscitated from cardiac arrest are initially comatose due to hypoxic ischemic encephalopathy. Later  depending on the patient’s condition, it can progress to improvement, worsening neurological outcome or even death. We planned this study to find out the neurological outcome of patients after in-hospital cardiac arrest admitted in our neurocritical care unit.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 99.00 Year(s)(—)
性别
All

入选标准

  • 1.Written informed consent from relative / attendant 2.All neurosurgical and neurological critically ill patients who achieve reversal of spontaneous circulation [ROSC]after in-hospital cardiac arrest.

排除标准

  • Patient does not achieve ROSC after cardiac arrest Out of hospital cardiac arrest with ROSC AGE less than 18 years Non consenting relative or attendant.

结局指标

主要结局

1.Neurological outcome assessed using Glasgow outcome scale extended at 3 and 6 months

时间窗: 1. at 3 and 6 months | 2. Factors assessment at 1st hr, 24hr, and 5th day post ROSC

2. Factors (demographic and disease related) affecting the outcome of patients at 3 and 6 months.

时间窗: 1. at 3 and 6 months | 2. Factors assessment at 1st hr, 24hr, and 5th day post ROSC

次要结局

  • Consciousness assessment at 1 hour, 24 hour and 5th day post ROSC ( assessed using GCS-P)(At 1 hour, 24 hour, 5th day post ROSC)
  • Post cardiac arrest complications(At hospital stay period, 3 months and 6 months post ROSC)
  • ICU length of stay(Duration of ICU stay)
  • Hospital length of stay(Duration of hospital admission)
  • Mortality(Till 6th month post ROSC)

研究者

发起方
All India Institute of medical sciences New Delhi
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Akhil M S

ALL INDIA INSTITUTE OF MEDICAL SCIENCE, NEW DELHI

研究点 (1)

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