Early and Late Prognosis in Patients With Guillain-Barre Syndrome

September 11, 2023 updated by: First Affiliated Hospital of Wenzhou Medical University
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

450

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Binbin Deng
  • Phone Number: dbinbin@aliyun.com

Study Locations

  • China
    • Zhejiang
      • Wenzhou, Zhejiang, China, 325000
        • Recruiting
        • First affiliated hospital of Wenzhou medical university
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • nonidiopathic Guillain-barre syndrome and Miller Fisher syndrome

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: immunoglobulin group
This group of patients was treated with intravenous immunoglobulin(30g ivgtt qd) for 5 days
Drug: Intravenous Immunoglobulins, Human
patients were treated with intravenous immunoglobulin(30g ivgtt qd) for 5 days
Experimental: methylprednisolone group
This group of patients was treated with methylprednisolone 500 MG Injection
Drug: Methylprednisolone 500 MG Injection
patients were treated with methylprednisolone
No Intervention: control group
This group of patients was treated without immunoglobulin or hormone
Experimental: mixed group
This group of patients was treated both with intravenous immunoglobulin and methylprednisolone.
Drug: Intravenous Immunoglobulins, Human
patients were treated with intravenous immunoglobulin(30g ivgtt qd) for 5 days
Drug: Methylprednisolone 500 MG Injection
patients were treated with methylprednisolone

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the severity of Guillain-barre syndrome
Time Frame: 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.
baseline, at 1 week, at 26 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

First Affiliated Hospital of Wenzhou Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 2, 2013

Primary Completion (Actual)

December 1, 2022

Study Completion (Estimated)

January 31, 2025

Study Registration Dates

First Submitted

December 27, 2022

First Submitted That Met QC Criteria

September 11, 2023

First Posted (Actual)

September 18, 2023

Study Record Updates

Last Update Posted (Actual)

September 18, 2023

Last Update Submitted That Met QC Criteria

September 11, 2023

Last Verified

December 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Dengbinbin

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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