Early and Late Prognosis in Patients With Guillain-Barre Syndrome

Phase 4

Recruiting

• Conditions: Guillain-Barre Syndrome
• Interventions: Drug: Intravenous Immunoglobulins, Human; Drug: Methylprednisolone 500 MG Injection

• Registration Number: NCT06041451
• Lead Sponsor: First Affiliated Hospital of Wenzhou Medical University

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2013-01-02
• Status Verified: 2022-12
• Primary Completion: 2022-12-01
• Study First Submitted: 2022-12-27
• Study First Submitted QC: 2023-09-11
• Last Update Submitted: 2023-09-11
• Study First Posted: 2023-09-18
• Last Update Posted: 2023-09-18
• Study Completion: 2025-01-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 450

Inclusion Criteria

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

Exclusion Criteria

• nonidiopathic Guillain-barre syndrome and Miller Fisher syndrome

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
mixed group	Intravenous Immunoglobulins, Human	This group of patients was treated both with intravenous immunoglobulin and methylprednisolone.
mixed group	Methylprednisolone 500 MG Injection	This group of patients was treated both with intravenous immunoglobulin and methylprednisolone.
immunoglobulin group	Intravenous Immunoglobulins, Human	This group of patients was treated with intravenous immunoglobulin(30g ivgtt qd) for 5 days
methylprednisolone group	Methylprednisolone 500 MG Injection	This group of patients was treated with methylprednisolone 500 MG Injection

Primary Outcome Measures

Name	Time	Method
the severity of Guillain-barre syndrome	baseline, at 1 week, at 26 weeks	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.

Trial Locations

Locations (1)

First Affiliated Hospital of Wenzhou Medical University; 🇨🇳 Wenzhou, Zhejiang, China