Predictors for Survival and Good Neurological Outcome in E-CPR and Non CPR Treated Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 700
- 试验地点
- 1
- 主要终点
- Physicians Global Assessment to measure quality of life
研究概览
简要总结
In ECPR, where CPR times often range from 30 to 120 minutes, only patients with good circulation during CPR survive, while non-survivors commonly suffer from anoxic brain injury. The selection process during CPR is challenging causing a general survival rate of just 2 out of 10, and the urgent need for better selection criteria has been emphasized. It it crucial to keep cardiac arrest times as short as possible, pre primed-ECMO can facilitate this.
The ECMO treatment and the long CPR times of ECPR can also affect the measurements of the neurologic prognostication guidelines after cardiac arrest, making its validity uncertain in this specific cohort. Further, the long-term neuropsychological follow-up is limited to a few patients, making it uncertain if ECPR gives the survivors good long-term life satisfaction or just a prolonged life.
Our overall aim is to optimize and improve the care pathway for ECPR patients by refining patient selection, assessing pre-primed ECMO, validating neurological prognostication guidelines, and understanding long-term outcomes and challenges faced by survivors.
Specific Aim 1: Evaluating predictors for good neurological outcomes in ECPR and to develop and validate (internally and externally) an evidence-based selection tool for ECPR.
Specific aim 2: To assess the sterility and function of pre-primed ECMO.
Specific aim 3: To evaluate the applicability of current guidelines for neurological prognostication after cardiac arrest in ECPR patients, and to assess the predictive value of individual and combined neurological tests in this specific patient population.
Specific aim 4: To determine the long-term neuropsychological outcomes, identify the problems survivors experience in daily life, and assess life satisfaction - by comprehensive follow-up visits with validated questionnaires and neuropsychology testing up to 12 years after the ECMO-treated cardiac arrest.
详细描述
Specific aim 1: The aim is to develop an ECPR prognostication tool and validate its performance. In development, possible predictors for good neurological outcomes are prospectively gathered. The predictive ability of the predictors is tested in univariate and multivariable analysis, with the aim of improving patient selection for ECPR. Patients from the Gothenburg ECPR cohort are included in the development study. External validation with the ECMO patients from the Prague OHCA trial, following guidelines for validation studies, will follow, as well as external validation with further patients from Gothenburg.
Specific aim 2: Cardiohelp ECMO circuits are set up dry, followed by wet-priming and used in the ECMO treatments of the centre. The circuits are cultured at ECMO-initiation and the incidence of positive cultures is assessed. The effect of the pre-primed time on ECMO function is also assessed.
Specific aim 3: The predictive ability of the current guideline for neurological prognostication of comatose patients in the ICU after cardiac arrest, from the European Resuscitation Council, is assessed in the ECPR cohort of Gothenburg. The diagnostic performance of individual predictors as well as the total accuracy of the prediction will be assessed.
Specific aim 4: A Long-term (1-12 years) follow-up of the ECPR patients will be performed, to determine the long-term neuropsychological outcomes.
4 A: Life satisfaction after ECPR will be assessed along with anxiety, depression, fatigue, cognitive function, and physical activity. The impact of these factors on life satisfaction will also be evaluated. QUALY will be calculated.
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
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ECMO-treated patients.
排除标准
- 未提供
结局指标
主要结局
Physicians Global Assessment to measure quality of life
时间窗: 1-15 years
Quality of Life in survivors after ECPR and ECMO without cardiac arrest, Measured with in depth interviews
Survival with Cerebral Performance Category 1 or 2.
时间窗: 1 year
Good neurological outcome in ECPR-patients
Positive blood Cultures
时间窗: 1 month
Infection rates in ECMO-patients
Cerebral Performance Scale (CPC)
时间窗: 1-7 years
Assessment of cerebral performance. 1-5, where 1-2 is considered good outcome
Trailmaking test
时间窗: 1-7 years
Assessmenty of cognitive function. Shorter time is better.
Modified Rankin scale (MRs)
时间窗: 1-7 years
Assessmenty of cognitive function. 0-6, where 0 is best.
Positive cultures of pre-primed ECMO circuits
时间窗: 0-90 days
ECMO circuits is pre-primed and cultures taken at the start of ECMO treatment
Performance of ECMO oxygenator function
时间窗: 0-60 days
Oxygenator resistance, and the needed FiO2 and sweep gas flow will be assessed
Euro Qualy - 5 dimension (EQ-5D)
时间窗: 1-7 years
Assesment of quality of life
New York heart association class (NYHA class)
时间窗: 1-7 years
Assessment of physical function.1-4, where 1 is best
Predictive ability of ERC neuro prognostication guidelines on ECPR patients
时间窗: 1 year
Diagnostic performance and ROC analysis of individual and total ERC predictors on outcome in ECPR
Short Form -36 (SF-36)
时间窗: 1-7 years
Quality of life. 8 scaled scores from 0-100, where 100 is best.
次要结局
未报告次要终点
研究者
Bengt Redfors
MD, PhD, Associate Professor
Sahlgrenska University Hospital