Early and Late Prognosis in Patients With Guillain-Barre Syndrome

NCT06041451 | Unknown Phase 4

• 1 other identifier: Dengbinbin
• Study Type: interventional
• Target: 450
• Locations: 1 country
• Sites: 1

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.

Conditions

Guillain-Barre Syndrome

Keywords

Guillain-barre syndrome; prognosis

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (4)

immunoglobulin group

EXPERIMENTAL

This group of patients was treated with intravenous immunoglobulin(30g ivgtt qd) for 5 days

Drug: Intravenous Immunoglobulins, Human

methylprednisolone group

EXPERIMENTAL

This group of patients was treated with methylprednisolone 500 MG Injection

Drug: Methylprednisolone 500 MG Injection

control group

NO INTERVENTION

This group of patients was treated without immunoglobulin or hormone

mixed group

EXPERIMENTAL

This group of patients was treated both with intravenous immunoglobulin and methylprednisolone.

Drug: Intravenous Immunoglobulins, Human; Drug: Methylprednisolone 500 MG Injection

Interventions

Intravenous Immunoglobulins, Human DRUG

patients were treated with intravenous immunoglobulin(30g ivgtt qd) for 5 days

immunoglobulin group; mixed group

Methylprednisolone 500 MG Injection DRUG

patients were treated with methylprednisolone

methylprednisolone group; mixed group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• nonidiopathic Guillain-barre syndrome and Miller Fisher syndrome

Sponsors & Collaborators

• First Affiliated Hospital of Wenzhou Medical University: lead

Study Sites (1)

First Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, 325000, China

RECRUITING

MeSH Terms

Conditions

Guillain-Barre Syndrome

Interventions

Immunoglobulins, Intravenous; Methylprednisolone; Injections

Condition Hierarchy (Ancestors)

Polyradiculoneuropathy; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Polyneuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Autoimmune Diseases; Immune System Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Immunoglobulin G; Immunoglobulin Isotypes; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Prednisolone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Drug Administration Routes; Drug Therapy; Therapeutics

Central Study Contacts

Binbin Deng

CONTACT

dbinbin@aliyun.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 27, 2022
• First Posted: September 18, 2023
• Study Start: January 2, 2013
• Primary Completion: December 1, 2022
• Study Completion: January 31, 2025
• Last Updated: September 18, 2023

Record last verified: 2022-12

Locations

CN (1)