NCT05104762

IVIG Versus Plasmapheresis in the Treatment of Guillian Barrie Syndrome Patients

IVIG Versus Plasmapheresis and Guillian Barrie Syndrome

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 81 (actual)
• Sponsor: Assiut University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Guillain-Barre Syndrome

Interventions

Type	Name	Description
DEVICE	plasmapheresis device	Group 1: 54 patients of Guillian Barrie syndrome undergo plasma exchange (5 sessions)
DRUG	Intravenous immunoglobulin	group 2: 27 patients undergo intravenous injection of immunoglobulin for 5 consecutive days of IVIG 0.4gm/kg/day.

Timeline

• Start date: 2021-09-01
• Primary completion: 2022-03-02
• Completion: 2023-03-03
• First posted: 2021-11-03
• Last updated: 2023-04-06

Locations

1 site across 1 country: Egypt