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临床试验/NCT02926703
NCT02926703已完成不适用

Lactate Compared to Creatine Kinase as Diagnostic Marker in Generalized Epileptic Seizure

RWTH Aachen University1 个研究点 分布在 1 个国家目标入组 85 人开始时间: 2015年11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
85
试验地点
1
主要终点
Comparison of the first measurements of serum lactate and creatine kinase concentrations in blood samples between patients admitted with either a generalized tonic-clonic seizure or a syncope

研究概览

简要总结

The investigators compared the feasibility of serum creatine kinase and serum lactate concentration as diagnostic markers to distinguish between generalized tonic-clonic seizures (GTCS) and syncopes in clinical settings that require fast-action treatment, such as in the emergency departments.

详细描述

The patients of this prospective study were selected from a sample of patients who were admitted to the emergency room of the University Hospital RWTH Aachen with an unclear impairment of consciousness. Only patients who later on were diagnosed as having experienced a GTCS or a syncope and whose serum lactate concentrations had been measured within 2 hours after the event were enrolled in the study. The investigators compared the specificity and sensitivity of the serum lactate concentrations at admission with the CK concentration at admission and the CK follow-up taken 10 to 48 hours after the event.

The values at admission were compared between patients from whom a blood sample was collected within 60 minutes after the event, and those from whom a blood sample was collected within 61-120 minutes after the event.

The comparison of initial lactate concentrations at admission with CK levels 10 - 48 hours later could only be performed on part of the patient collective because the other patients were already discharged at this time-point and could therefore not be included.

The initial blood samples were taken at patient arrival in the emergency room. The follow up was performed during the inpatient stay.

Serum lactate and CK concentrations between patient groups were statistically compared with a Mann-Whitney-U test. We defined cut-off values and their sensitivity and specificity by Receiver Operating Characteristic (ROC) analysis.

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

  • Patients with generalized tonic-clonic seizures and syncopes and whose blood samples were taken within 2 hours after the event
  • 18 years or older
  • Observed seizure
  • Time of the event before admission was known
  • Diagnosis of an epileptic seizure or syncope had been entered in the final discharge report

排除标准

  • Age < 18 years old
  • Competing explanations for serum lactate or CK elevation e.g. shock or trauma
  • Lack of capacity for consent

结局指标

主要结局

Comparison of the first measurements of serum lactate and creatine kinase concentrations in blood samples between patients admitted with either a generalized tonic-clonic seizure or a syncope

时间窗: 2 hours

次要结局

  • Comparison of the serum lactate concentrations at admission with the CK follow-up taken 10 to 48 hours after the event(48 hours)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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