Prognostic Indicators of Gullian-Barre Syndrome

March 12, 2024 updated by: Amira Abdelhakem Sayed Amin, Assiut University

Prognostic Indicators of Gullian-Barre Syndrome at Assiut University Children Hospital

Prognostic indicators of Gullian-Barre syndrome and the predictive factors associated with worse prognosis in the Guillain-Barré syndrome (GBS), which can be helpful to fully evaluate the disease progression and provide proper treatments.

Study Overview

Status

Not yet recruiting

Conditions

Detailed Description

Guillain Barre Syndrome (GBS) is an autoimmune disorder with post-infectious polyneuropathy involving motor, sensory and sometimes the autonomic nerves. With the eradication of wild polio virus infection, GBS has become the most common cause of acute flaccid paralysis in both the developed and developing countries.GBS occurs throughout the world with a median annual incidence of 1.3 cases per population of 100 000.

GBS is characterized by ascending paralysis (lower limb numbness, paraesthesia or pain followed by weakness which ascends symmetrically and gradually progresses over a period of 1 to 28 days with maximum severity of weakness by four weeks after the onset). Bulbar involvement is seen in 50% cases and autonomic disturbances are seen in about 20%. Since there may be mortality related to acute complications of respiratory muscle paralysis and morbidity related to the long duration of the paralysis.

It can be classified electrophysiologically into demyelinating and axonal subtypes. Acute inflammatory demyelinating polyneuropathy (AIDP) is the demyelinating subtype, while acute motor axonal (AMAN) and acute motor-sensory axonal neuropathy (AMSAN) are the axonal subtypes. It is difficult to differentiate between them clinically and nerve conduction studies (NCS) can play an important role. Determining the electrophysiological subtype is useful as it can give insights into the underlying pathophysiology. This has both therapeutic and prognostic significance. Various electrodiagnostic criteria sets have been proposed to differentiate between the demyelinating and axonal subtypes.

GBS typically occurs after an infectious disease (Two-thirds of patients report symptoms of a respiratory or gastrointestinal tract infection before the onset of GBS. In about half of patients with GBS, a specific type of preceding infection can be identified and Campylobacter jejuni is responsible for at least one-third of these infections. Other pathogens that cause antecedent infections related to GBS are cytomegalovirus, Epstein- Barr virus, Mycoplasma pneumonia, Haemophilus influenzae, and influenza A virus) in which the immune response generates antibodies that crossreact with gangliosides at nerve membranes. This autoimmune response results in nerve damage or functional blockade of nerve conduction. The type of preceding infection and the specificity of the antiganglioside antibodies largely determine the subtype and clinical course of GBS.

The chance of recovery was significantly affected by age, antecedent gastroenteritis, disability, electrophysiological signs of axonopathy, latency to nadir and duration of active disease.The main treatments did not seem to affect the chance of recovery.

Acute motor axon neuropathy, diabetes, high blood pressure, uroschesis, high body temperature, ventilator support,consciousness disorder, absence of upper respiratory tract preceding infection, hyperglycemia, hyponatremia,hypoalbuminemia, high leukocyte count, hyperfibrinogenemia, abnormal hepatic and renal function were demonstrated as poor prognostic factors.

Dysautonomic syndrome, cardiac arrest and respiratory failure were the leading causes of death.

Paralysis of respiratory muscles is a dreaded complication that occurs in one-fourth of the subjects. Respiratory weakness occurs due to the involvement of both inspiratory and expiratory muscles. Diaphragmatic weakness occurs due to phrenic nerve demyelination. Careful and close monitoring is mandatory to identify patients at high risk for respiratory failure, and triage them to the Intensive Care Unit (ICU) and mechanical ventilation.

The diagnosis was based mostly on clinical judgement and was confirmed by autopsy only in a few instances. In the presence of suggestive findings the complementary test as demyelinising changes in the nerve conduction studies (NCS) or albuminocytological dissociation in the cerebrospinal fluid (CSF), help to confirm the diagnosis.

  • Consider specific treatment with IVIg or PE:

    • IVIg is usually the first- line therapy for children with GBS. Although some paediatric centres administer IVIg as 2 g/kg (body weight) over 2 days, rather than the standard adult regimen of 2 g/kg (body weight) over 5 days.

    • plasma exchange can be difficult to perform in young children, and care should be taken in patients with autonomic cardiovascular instability because of the large volume shifts involved in the plasma exchange procedure.

      1. Indications to start IVIg or PE:

        Severely affected patients (inability to walk unaided, GBS disability scale ≥3).

        Unknown whether IVIg is effective:

        Mildly affected patients (GBS disability scale ≤2) or MFS patients .

      2. Indications for re-treatment with IVIg:
    • Secondary deterioration after initial improvement or stabilisation (treatment-related fluctuation): treat with 0·4 g/kg for 5 days.
    • No proven effect of re-treatment with IVIg in patients who continue to worsen.
  • Steroids :

Oral steroids or intravenous methylprednisolone (500 mg daily for 5 consecutive days) alone are not beneficial in GBS. The combination of IVIg and intravenous methylprednisolone was not more effective than IVIg alone.

-Give good general care: Monitor progression and prevent and manage potentially fatal complications.

  • Indication for admission to an intensive care unit:

    • Rapid progressive severe weakness often with impaired respiration (vital capacity <20 mL/kg).
    • Need for artifi cial ventilation Insufficient.
    • swallowing with high chance of pulmonary infection.
    • Severe autonomic dysfunction.
  • Physiotherapy and Rehabilitation.

Study Type

Observational

Enrollment (Estimated)

60

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

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

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

children with GBS, presenting with weakness, diagnosed on clinical and/or electrophysiological grounds, were enrolled. The enrolled children underwent a detailed clinical-assessment followed by nerve conduction studies.

Description

Inclusion Criteria:

  • Patients 2 - 18 years old with guillian barrie syndrome admitted at Assiut university children hospital.

Acceptance to participate in this study .

Exclusion Criteria:

  • Patients aged less than 2 years and more than 18 years old . Children or Parents who refused to participate in this study.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prognostic indicators of Gullian-Barre syndrome
Time Frame: Baseline
The predictive factors with worse prognosis
Baseline

Collaborators and Investigators

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

Sponsor

Assiut University

Investigators

  • Principal Investigator: Amira A Sayed Amin, Resident, Assiut University
  • Study Director: Gamal A Abdelaal Asker, Professor, Assiut University
  • Study Director: Azhar A Mohammed Mohammed, Lecturer, Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Estimated)

March 1, 2024

Primary Completion (Estimated)

April 1, 2025

Study Completion (Estimated)

June 1, 2025

Study Registration Dates

First Submitted

February 21, 2024

First Submitted That Met QC Criteria

March 2, 2024

First Posted (Actual)

March 8, 2024

Study Record Updates

Last Update Posted (Actual)

March 15, 2024

Last Update Submitted That Met QC Criteria

March 12, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Prognostic indicators of GBS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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