IVIG Versus Plasmapheresis in the Treatment of Guillian Barrie Syndrome Patients

Study Overview
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Brief Summary
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In this study, the investigators address the question: whether treatment with IVIG is superior to treatment using plasmapheresis for functional recovery of patients with GBS? Recovery was quantified using: The changes in the A-Clinical grading scale MRC ( medial research council sum score ) and B-overall neuropathy limitations scale as the primary outcome and the changes in Neurophysiological study 3 months after treatment as a secondary outcome. This information will be used to evaluate which treatment is more beneficial to GBS patients.

Detailed Description
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Guillain-Barré syndrome (GBS) is an inflammatory disease of the PNS and is the most common cause of acute flaccid paralysis, with an annual global incidence of approximately 1-2 per 100,000 person-years. Patients with GBS typically present with weakness and sensory signs in the legs that progress to the arms and cranial muscles, although the clinical presentation of the disease is heterogeneous and several distinct clinical variants exist. Diagnosis of GBS is based on the patient's history and neurological, electrophysiological, and cerebrospinal fluid (CSF) examinations. Electrophysiological studies: provide evidence of peripheral nervous system (PNS) dysfunction and can distinguish between the subtypes of GBS: acute inflammatory demyelinating polyradiculoneuropathy (AIDP), acute motor axonal neuropathy (AMAN), and acute motor-sensory axonal neuropathy (AMSAN). Disease progression can be rapid, and most patients with GBS reach their maximum disability within 2 weeks. About 20% of patients with GBS develop respiratory failure and require mechanical ventilation. Cardiac arrhythmias and blood pressure instability can occur owing to the involvement of the autonomic nervous system. Immunomodulatory therapy should be started if patients are unable to walk independently for 10 m. Evidence on treatment efficacy in patients who can still walk independently is limited, but treatment should be considered, especially if these patients display rapidly progressive weakness or other severe symptoms such as autonomic dysfunction, bulbar failure, or respiratory insufficiency. Clinical trials have demonstrated a treatment effect for intravenous immunoglobulin (IVIg) when started within 2 weeks of the onset of weakness and for plasma exchange when started within 4 weeks.

Official Title
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IVIG Versus Plasmapheresis and Guillian Barrie Syndrome

Conditions
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Guillain-Barre Syndrome

Intervention / Treatment
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* Device: plasmapheresis device
* Drug: Intravenous immunoglobulin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age: 18-70 years old, Onset: Recent onset of GBS through the first 2 weeks. Gender: Male or Female Inclusion Criteria. Exclusion Criteria: patients with metabolic disorders, or malignancy, other causes of peripheral neuropathy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 2 groups of patients with Guillian Barrie syndrome were subjected to plasmapheresis or IVIG by percentage 2:1 respectively according to availability of IVIG
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Arm 1 plasmapheresis<br>Arm 1 (plasmapheresis): This study will be conducted at Assiut University at Neurology and psychiatry department as Group 1 of patients presented with Guillian Barrie syndrome (54 patients) will be subjected to plasmapheresis after assessment of clinical state and scales including MRC, Erasmus Guillain-Barre respiratory insufficiency score and Overall neuropathy limitation scale and Neurophysiological studies. Each patient was evaluated at baseline and at Follow up assessment points (one month and 3 months, one year follow up) | Device: plasmapheresis device<br>* Group 1: 54 patients of Guillian Barrie syndrome undergo plasma exchange (5 sessions)<br>* Other names: plasma exchange device;|
| Active Comparator: Arm 2: Intravenous injection of immunoglobulin<br>This study will be conducted at Assiut University at Neurology and psychiatry department as Group 2 of patients presented with Guillian Barrie syndrome (27 patients) will be subjected to intravenous injection of immunoglobulin after assessment of clinical state and scales including MRC, Erasmus Guillain-Barre respiratory insufficiency score, and Overall neuropathy limitation scale and Neurophysiological studies. Each patient was evaluated at baseline and at Follow up assessment points (one month and 3 months, one year follow up). | Drug: Intravenous immunoglobulin<br>* group 2: 27 patients undergo intravenous injection of immunoglobulin for 5 consecutive days of IVIG 0.4gm/kg/day.<br>* Other names: IVIG;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 (points): sum score of muscle power in both upper limbs and lower limbs in points . | the points change from baseline scale and after 3 months follow up | 
| 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) | the changes in points from baseline assessment score to 3 months follow up assessment score. | 
| 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 ) | the change in points from baseline assessment score to 3 months follow up assessment score. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neurophysiological study: Distal latency in mill second, Nerve conduction velocities in Meter/second, and F-wave latency mill second | Neurophysiological study neurophysiological study pre- and after 3 months change of degree of affection and improvement in latency in nerve conduction m/ sec. amplitude m/v , velocity of nerve /s conduction and F-wave of both upper limbs and lower limbs | the change in points from baseline assessment score to 3 months follow up assessment score. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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IVIG / plasmapheresis and Guillain-Barre Syndrome