Early and Late Prognosis in Patients With Guillain-Barre Syndrome

Guillain-Barre Syndrome Clinical Trial

Official title:

Early and Late Prognosis in Patients With Guillain-Barre Syndrome

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06041451
• Other study ID #: Dengbinbin
• Status: Recruiting
• Phase: Phase 4
• Start date: January 2, 2013
• Est. completion date: January 31, 2025

Study information

• Verified date: December 2022
• Source: First Affiliated Hospital of Wenzhou Medical University
• Contact: Binbin Deng
• Phone: dbinbin@aliyun.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this observational study is to explore significant indicators to predict the early prognosis and late prognosis in patients with Guillain-Barre syndrome.

Description:

This is a multicenter study(approximately three) with over 450 subjects.Clinical data were collected by consulting the patient's electronic history. The data included demographic information, blood biochemical markers, clinical characteristics and electromyography. All participants provided their written informed consent to participate in this study.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 450
• Est. completion date: January 31, 2025
• Est. primary completion date: December 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• patients fulfilled clinical, biological, and electrophysiology criteria for Guillain-barre syndrome.

Exclusion Criteria:

• nonidiopathic Guillain-barre syndrome and Miller Fisher syndrome

Related Conditions & MeSH terms

• Guillain-Barre Syndrome
• Syndrome

Intervention

Drug:
• Intravenous Immunoglobulins, Human
patients were treated with intravenous immunoglobulin(30g ivgtt qd) for 5 days
• Methylprednisolone 500 MG Injection
patients were treated with methylprednisolone

Locations

Country	Name	City	State
China	First Affiliated Hospital of Wenzhou Medical University	Wenzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital of Wenzhou Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the severity of Guillain-barre syndrome	The Guillain-barre syndrome disability score is a wide scale for the severity of Guillain-barre syndrome (0, optimal health; 1, minor symptoms, able to run; 2, able to walk unaided 10 m, unable to run; 3, able to walk 10 m across an open space with help; 4 bedridden or wheelchair users; 5, require assisted ventilation; 6, dead).The higher the score, the worse the prognosis.	baseline, at 1 week, at 26 weeks