Firm Observational Clinical Unicenter Study on Guillain Barré Syndrome (FOCUS on GBS)

Firm Observational Clinical Unicenter Study on Guillain Barré Syndrome (FOCUS on GBS)

The aim of this retrospective observational single-center cohort study is to gain a deeper understanding regarding the frequency, the clinical and electrophysiologic characteristics (e.g., the diagnostic work up), complications, treatment regimes, and their associations with specific courses of disease and outcomes in adult patients with the suspected or proven diagnosis of GBS.

Study Overview

• Status: Recruiting
• Conditions: Guillain-Barre Syndrome (GBS)
• Intervention / Treatment: Other: data collection

Detailed Description

Guillain Barré Syndrome (GBS) is a rare and life-threatening neurological emergency. The aim of this retrospective study including adult GBS patients from the last 15 years treated at the University Hospital of Basel is to assess data regarding diagnostic workup, treatment, clinical course including complications and outcomes.

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: Raoul Sutter, Prof. Dr. med.; Phone Number: +41 61 32 87 928; Email: raoul.sutter@usb.ch
• Study Contact Backup: Name: Lisa Hert, Dr. med.; Email: lisa.hert@usb.ch

Study Locations

• Switzerland
  • Basel, Switzerland, 4031
    • Recruiting
    • Clinic for Intensive Care Medicine; University Hospital Basel
    • Contact: Lisa Hert, Dr. med.; Email: lisa.hert@usb.ch
    • Contact: Raoul Sutter, Prof. Dr. med.; Email: raoul.sutter@usb.ch
    • Principal Investigator: Raoul Sutter, Prof. Dr. med.
    • Sub-Investigator: Lisa Hert, Dr. med.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

patients with the suspected and with the final proven diagnosis of GBS in the years 2005-2021

Description

Inclusion Criteria:

• suspected diagnosis of GBS, who have been treated at the University Hospital of Basel from 01.01.2005-28.02.2021

Exclusion Criteria:

• Patients with documented refusal of the general consent.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
frequency of GBS	frequency of GBS of all consecutive adult patients with the suspected initial diagnosis of GBS (admitted to the University Hospital Basel)	one time retrospective assessment at baseline
clinical characteristics of GBS	clinical characteristics of GBS of all consecutive adult patients with the suspected initial diagnosis of GBS (admitted to the University Hospital Basel)	one time retrospective assessment at baseline
electrophysiologic characteristics of GBS	electrophysiologic characteristics of GBS of all consecutive adult patients with the suspected initial diagnosis of GBS (admitted to the University Hospital Basel)	one time retrospective assessment at baseline
complications of GBS	complications of GBS of all consecutive adult patients with the suspected initial diagnosis of GBS (admitted to the University Hospital Basel)	one time retrospective assessment at baseline
treatment regimes of GBS	treatment regimes of GBS of all consecutive adult patients with the suspected initial diagnosis of GBS (admitted to the University Hospital Basel)	one time retrospective assessment at baseline
outcomes of GBS	treatment regimes of GBS of all consecutive adult patients with the suspected initial diagnosis of GBS (admitted to the University Hospital Basel)	one time retrospective assessment at baseline

Collaborators and Investigators

• Sponsor: University Hospital, Basel, Switzerland
• Investigators: Principal Investigator: Raoul Sutter, Prof. Dr. med., Clinic for Intensive Care Medicine, University Hospital Basel

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2021
• Primary Completion (Anticipated): December 1, 2022
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: March 29, 2021
• First Submitted That Met QC Criteria: April 1, 2021
• First Posted (Actual): April 2, 2021

Study Record Updates

• Last Update Posted (Actual): May 5, 2022
• Last Update Submitted That Met QC Criteria: May 4, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Disease; Neuromuscular Diseases; Peripheral Nervous System Diseases; Polyradiculoneuropathy; Polyneuropathies; Syndrome; Guillain-Barre Syndrome
• Other Study ID Numbers: 2021-00402; ko21Sutter

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No