Kinetics and Prognostic Value of NeuroFilament Light in Post-cardiac Arrest: A Prospective Multicenter Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 270
- 试验地点
- 1
- 主要终点
- modified Rankin Scale (mRS)
研究概览
简要总结
The purpose of this study is to assess the prognostic value of absolute value and kinetic of neurofilament light chain (NFL) collected at different time points (at admission, 12h, 24h, 48h, 72h, 96h, and day 7 after ICU admission) in predicting poor and good neurological outcome in comatose patients after cardiac arrest.
详细描述
A large majority of patients resuscitated after cardiac arrest (CA) are comatose following the return of spontaneous circulation and require admission to the intensive care unit (ICU). Unfortunately, many of them die during their ICU stay, mainly following the decision to withdraw life-sustaining therapies due to ischemic and hypoxic brain injuries considered irreversible. Early identification of these neurological injury is therefore one of the major challenges for intensivists, in order to tailor the intensity of care.
Currently, the recommended strategy consists of applying a multimodal prognostic approach. This algorithm allows prediction of poor neurological outcome in approximately 50% of cases, according to various studies. This highlights the need for new early prognostic markers to predict both unfavorable and favorable outcomes.
Regarding biomarkers of brain injury, European guidelines recommend the measurement of serum NSE, a biomarker of neuronal injury that is now commonly used. An NSE level > 60 µg/L at 48 and/or 72 hours after cardiac arrest predicts poor neurological outcome with good accuracy (AUC between 0.80 and 0.92 depending on the study), high specificity but limited sensitivity. Moreover, uncertainty remains regarding the optimal threshold value to use, and variable results have been reported across clinical studies. Finally, early serum NSE levels (within the first 24-48 hours) have limited prognostic value, which restricts their usefulness for the early identification of patients likely to have a poor outcome. These limitations have highlighted the need to identify new biomarkers of brain injury to better assess the prognosis of these patients.
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
- 否
入选标准
- •Patients admitted to the ICU for cardiac arrest,
- •Patients who regained consciousness following in-hospital or out-of-hospital cardiac arrest,
- •Patients in a coma upon arrival in the ICU, defined by a Glasgow Coma Scale (GCS) score <8,
- •Patients included in the AfterROSC2 cohort,
排除标准
- •Terminally ill patients (death expected within 3 hours of admission to the ICU),
- •Patients under legal guardianship,
- •Pregnant women,
- •Patients not enrolled in a social security program,
- •Prior inclusion in the CINEFIL study,
- •Restriction of active therapies prior to the first NFL biomarker assay,
- •Objection by a family member or trusted person, if present
研究组 & 干预措施
Patients
Patients
干预措施: Value of neurofilament light chain (NFL) at different time points (Other)
结局指标
主要结局
modified Rankin Scale (mRS)
时间窗: 3 months
Neurological outcome assessed by the modified Rankin Scale (mRS) (An unfavorable outcome is defined as a modified Rankin Scale (mRS) score between 4 and 6 (severe neurological sequelae, persistent coma, or death), and a favorable outcome as a modified Rankin Scale (mRS) score between 0 and 3 (no sequelae, mild to moderate neurological sequelae))
次要结局
- Mortality(At ICU discharge, up to 3 months)
- Early myoclonus(<72 hours)
- Myoclonus status(<72 hours post-CA)
- Pupillary and corneal reflexes(72 hours post-CA)
- Pupillary and corneal reflexes(3 months)
- Electroencephalogram (EEG)(3 months)
- Somatosensory evoked potentials(3 months)
- Auditory evoked potentials(3 months)