Assessment of Severity and Prognosis for Patients With Status Epileptics(SE)

Status Epileptics Clinical Trial

Official title:

Assessment of Severity and Prognosis for Patients With Status Epileptics

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02269137
• Other study ID #: Xijing-49
• Status: Recruiting
• Phase: N/A
• First received: October 15, 2014
• Last updated: December 31, 2015
• Start date: March 2008
• Est. completion date: December 2017

Study information

• Verified date: December 2015
• Source: Xijing Hospital
• Contact: Wen Jiang, MD
• Phone: 02984771319
• Email: jiangwen[@]fmmu.edu.cn
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Observational [Patient Registry]

Clinical Trial Summary

To characterize the functional outcomes and prognostic factors for convulsive status epilepticus (SE) and to further develop and validate a simple and practicable scoring system for outcome prediction.

Description:

1. Retrospectively study all patients with convulsive SE treated between March, 2008, and November, 2014.

2. Develop a scoring system for outcome prediction.

3. Prospectively validate the predictive accuracy of the scoring system

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 2017
• Est. primary completion date: August 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• 30 min or more of (1) continuous clinical seizure activities or (2) recurrent seizure activities without recovery(returning to baseline)between seizures;

• clinical data is complete.

Exclusion Criteria:

• hypoglycemia SE;psychogenic SE;any other pseudo-SE

Study Design

Observational Model: Cohort

Related Conditions & MeSH terms

• Epilepsy
• Status Epileptics

Locations

Country	Name	City	State
China	The Department of Neurology, Xijing Hospital	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
Xijing Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The modified Rankin scale		3 months after discharge	No
Secondary	The modified Rankin scale		on discharge	No