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Prognosis in Patients With Guillain-Barre Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT06032741
Recruitment Status : Recruiting
First Posted : September 13, 2023
Last Update Posted : September 13, 2023
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease
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.

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Study Type : Observational
Estimated Enrollment : 450 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Prognosis in Patients With Guillain-Barre Syndrome
Actual Study Start Date : January 2, 2013
Actual Primary Completion Date : December 1, 2022
Estimated Study Completion Date : January 31, 2025


Group/Cohort
mechanical ventilation group
Patients with Guillain-Barré Syndrome require mechanical ventilation during hospitalization
no mechanical ventilation group
Patients with Guillain-Barré Syndrome do not require mechanical ventilation during hospitalization



Primary Outcome Measures :
  1. 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)(deceased).The higher the score, the worse the prognosis.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
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.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • nonidiopathic Guillain-barre syndrome and Miller Fisher syndrome

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06032741


Contacts
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Contact: Binbin Deng dbinbin@aliyun.com

Locations
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China, Zhejiang
First Affiliated Hospital of Wenzhou Medical University Recruiting
Wenzhou, Zhejiang, China, 325000
Contact: Binbin Deng, Doctor    +8613695720610    dbinbin@aliyun.com   
Sponsors and Collaborators
First Affiliated Hospital of Wenzhou Medical University
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Responsible Party: First Affiliated Hospital of Wenzhou Medical University
ClinicalTrials.gov Identifier: NCT06032741    
Other Study ID Numbers: GBS
First Posted: September 13, 2023    Key Record Dates
Last Update Posted: September 13, 2023
Last Verified: December 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by First Affiliated Hospital of Wenzhou Medical University:
Guillain-Barre Syndrome
Additional relevant MeSH terms:
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Guillain-Barre Syndrome
Syndrome
Disease
Pathologic Processes
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