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临床试验/NCT05104762
NCT05104762已完成2 期

IVIG Versus Plasmapheresis and Guillian Barrie Syndrome

Assiut University1 个研究点 分布在 1 个国家目标入组 81 人开始时间: 2021年9月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
81
试验地点
1
主要终点
Overall neuropathy limitations scale (ONLS) .

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Investigator, Outcomes Assessor)

盲法说明

Triple-blind (participant and investigator, accessor) using closed envelope 2:1 was applied. 5 sessions of plasmapheresis: IVIG 0.4g IVIG/Kg /day for 5 consecutive days. The investigators didn't know what was the type of treatment that patients received and the patient didn't know that there is another line of treatment.

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age: 18-70 years old,
  • Onset: Recent onset of GBS through the first 2 weeks.
  • Gender: Male or Female Inclusion Criteria.

排除标准

  • patients with metabolic disorders, or malignancy,
  • other causes of peripheral neuropathy

研究组 & 干预措施

Arm 1 plasmapheresis

Active Comparator

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)

干预措施: plasmapheresis device (Device)

Arm 2: Intravenous injection of immunoglobulin

Active Comparator

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).

干预措施: Intravenous immunoglobulin (Drug)

结局指标

主要结局

Overall neuropathy limitations scale (ONLS) .

时间窗: the changes in points from baseline assessment score to 3 months follow up assessment score.

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)

Clinical grading scale MRC ( medial research council sum score )

时间窗: the points change from baseline scale and after 3 months follow up

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 .

ERASMUS GBS respiratory insufficiency score EGRIS

时间窗: the change in points from baseline assessment score to 3 months follow up assessment score.

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 )

次要结局

  • Neurophysiological study: Distal latency in mill second, Nerve conduction velocities in Meter/second, and F-wave latency mill second(the change in points from baseline assessment score to 3 months follow up assessment score.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Eman M. Khedr

professor

Assiut University

研究点 (1)

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