Ignite Creation Date:
2025-12-24 @ 7:48 PM
Ignite Modification Date:
2026-03-02 @ 4:01 PM
Study NCT ID:
NCT02926703
Status:
COMPLETED
Last Update Posted:
2016-10-07
First Post:
2016-10-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Lactate Compared to Creatine Kinase as Diagnostic Marker in Generalized Epileptic Seizure
Sponsor:
RWTH Aachen University
Organization:
Study Overview
Official Title:
Lactate Compared to Creatine Kinase as Diagnostic Marker in Generalized Epileptic Seizure
Status:
COMPLETED
Status Verified Date:
2016-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
Detailed Description:
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| EK 267/15 | OTHER | local ethics committee | View |