Predictors and Prognostic Factors of Gullian Barrie Syndrome Outcome

NCT04927598 | Completed DMC

• 1 other identifier: Gullian Barrie syndrome
• Study Type: observational
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to identify clinical and biological determinants and factors that predict outcome including primary outcome (percentage of changes in clinical scales pre- and after 3 months ) and secondary outcome depending on neurophysiologiacal studies and prognostic factors in individual patients with Guillain-Barre syndrome i individuals managed by plasmapheresis and IVIG immunoglobulin . This information will be used to understand the diversity in clinical presentation and response to treatment of GBS.

Conditions

Guillain-Barre Syndrome

Keywords

predictors and prognostic factors of outcome

Outcome Measures

Primary Outcomes (5)

• clinical scales :The GBS Disability Scale

  the percentage of changes in clinical scales pre- and 3 months after treatment depending on clinical assessment scales : The GBS Disability Scale has six levels: 0 points (healthy), 1 point (minor symptoms and capable of running), 2 points (able to walk 10 m without assistance but unable to run), 3 points (able to walk 10 m across an open space with help), 4 points(bedridden or wheelchair-bound), 5points (requiring assisted ventilation for at least part of the day), and 6 points (dead).

  change from baseline scale at 3 months

• Clinical grading scale MRC ( medial research council sum score )

  Clinical grading scale MRC ( medial research council sum score ) from zero ( no power ) up to 60 full power : sum score of muscle power in both upper limbs and lower limbs in points .

  change from baseline scale at 3 months

• ERASMUS GBS respiratory insufficiency score EGRIS :

  ERASMUS GBS respiratory insufficiency score EGRIS : Predict the probability of respiratory insufficiency within the first week of admission, in individual patients with Guillain-Barre . syndrome from zero to 7 points score : 0 point ( no affection ) , 7 point ( severe affection )

  change from baseline scale at 3 months

• Erasmus GBS Outcome Score (EGOS)

  Erasmus GBS Outcome Score (EGOS) is a prognostic model based on age, diarrhea, and GBS disability score at 2 weeks after hospital admission that accurately predicts the chance of being able to walk independently at 3 months

  change from baseline scale at 3 months

• overall neuropathy limitations scale ONLS .

  it is modified disability sum score : sum of arm grade and leg grade limitation score ; arm grade from zero point ( less limitation ) to 5 points ( most limitation ) and leg grade from zero point ( less limitation) to 7 points (more limitation)

  change from baseline scale at 3 months

Secondary Outcomes (1)

• comparison between pre and post neurophysiological studies

  change from baseline scale at 3 months

Interventions

plasmapheresis DEVICE

patients of Gullian Barrie syndrome undergo plasmapharesis

Eligibility Criteria

• Age: 10 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Guillian Barre syndrome ( GBS ) is a rare disease , its incidence nearly , 0.8 - 1.8 case / 100000 population ( 16,17) . Total coverage of patients with ( GBS ) fitting inclusion criteria and seeking care at Neuro-psychiatric clinics or admitted at Neuro-psychiatry hospital through one year duration about 3 -4 cases per month (36 -38 case per year ) .

You may not qualify if:

• patients with metabolic disorders, others

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut university

Asyut, Asyut Governorate, Egypt

Location

Related Publications (11)

• van Doorn PA, Ruts L, Jacobs BC. Clinical features, pathogenesis, and treatment of Guillain-Barre syndrome. Lancet Neurol. 2008 Oct;7(10):939-50. doi: 10.1016/S1474-4422(08)70215-1.

  PMID: 18848313 BACKGROUND

• Raphael JC, Chevret S, Hughes RA, Annane D. Plasma exchange for Guillain-Barre syndrome. Cochrane Database Syst Rev. 2012 Jul 11;(7):CD001798. doi: 10.1002/14651858.CD001798.pub2.

  PMID: 22786475 BACKGROUND

• Fokke C, van den Berg B, Drenthen J, Walgaard C, van Doorn PA, Jacobs BC. Diagnosis of Guillain-Barre syndrome and validation of Brighton criteria. Brain. 2014 Jan;137(Pt 1):33-43. doi: 10.1093/brain/awt285. Epub 2013 Oct 26.

  PMID: 24163275 BACKGROUND

• van Doorn PA. Diagnosis, treatment and prognosis of Guillain-Barre syndrome (GBS). Presse Med. 2013 Jun;42(6 Pt 2):e193-201. doi: 10.1016/j.lpm.2013.02.328. Epub 2013 Apr 28.

  PMID: 23628447 BACKGROUND

• van Nes SI, Vanhoutte EK, van Doorn PA, Hermans M, Bakkers M, Kuitwaard K, Faber CG, Merkies IS. Rasch-built Overall Disability Scale (R-ODS) for immune-mediated peripheral neuropathies. Neurology. 2011 Jan 25;76(4):337-45. doi: 10.1212/WNL.0b013e318208824b.

  PMID: 21263135 BACKGROUND

• Mori M, Kuwabara S, Fukutake T, Hattori T. Intravenous immunoglobulin therapy for Miller Fisher syndrome. Neurology. 2007 Apr 3;68(14):1144-6. doi: 10.1212/01.wnl.0000258673.31824.61.

  PMID: 17404197 BACKGROUND

• Kalita J, Misra UK, Goyal G, Das M. Guillain-Barre syndrome: subtypes and predictors of outcome from India. J Peripher Nerv Syst. 2014 Mar;19(1):36-43. doi: 10.1111/jns5.12050.

  PMID: 24456386 BACKGROUND

• Dornonville de la Cour C, Jakobsen J. Residual neuropathy in long-term population-based follow-up of Guillain-Barre syndrome. Neurology. 2005 Jan 25;64(2):246-53. doi: 10.1212/01.WNL.0000149521.65474.83.

  PMID: 15668421 BACKGROUND

• van Koningsveld R, Steyerberg EW, Hughes RA, Swan AV, van Doorn PA, Jacobs BC. A clinical prognostic scoring system for Guillain-Barre syndrome. Lancet Neurol. 2007 Jul;6(7):589-94. doi: 10.1016/S1474-4422(07)70130-8.

  PMID: 17537676 BACKGROUND

• Walgaard C, Lingsma HF, Ruts L, van Doorn PA, Steyerberg EW, Jacobs BC. Early recognition of poor prognosis in Guillain-Barre syndrome. Neurology. 2011 Mar 15;76(11):968-75. doi: 10.1212/WNL.0b013e3182104407.

  PMID: 21403108 BACKGROUND

• Khedr EM, Shehab MM, Mohamed MZ, Mohamed KO. Early electrophysiological study variants and their relationship with clinical presentation and outcomes of patients with Guillain-Barre syndrome. Sci Rep. 2023 Aug 26;13(1):14000. doi: 10.1038/s41598-023-41072-x.

  PMID: 37634022 DERIVED

MeSH Terms

Conditions

Guillain-Barre Syndrome

Interventions

Plasmapheresis

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)

Blood Component Removal; Therapeutics; Sorption Detoxification; Extracorporeal Circulation; Surgical Procedures, Operative

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: April 15, 2021
• First Posted: June 16, 2021
• Study Start: October 20, 2020
• Primary Completion: October 15, 2021
• Study Completion: April 1, 2022
• Last Updated: December 8, 2022

Record last verified: 2022-12

Locations

EG (1)