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临床试验/CTRI/2024/02/063206
CTRI/2024/02/063206尚未招募4 期

Comparing the Therapeutic Modalities of Guillain–Barré Syndrome: Therapeutic Plasma Exchange versus Intravenous Immunoglobulin

SCB Medical College and Hospital1 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2024年3月8日最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
45
试验地点
1
主要终点
A decrease in GBS Disability scale by 1 or more points at discharge as compared to the same at admission

研究概览

简要总结

Guillain–Barré syndrome (GBS) is the most common cause of acute flaccid paralysis worldwide, with an annual global incidence of approximately 1–2 per 100,000 person-year. Specific treatment of the patients comprises intravenous immunoglobulin (IVIG) or plasma exchange (PE). Majority of studies comparing either modalities of treatment has been conducted in developed countries with better Hospital infrastructure and mechanical ventilation facilities. Therefore it’s necessary to elicit the outcome of GBS in resource poor settings like ours. Moreover most of the studies comparing either modalities of therapy, have been done retrospectively. Further, studies evaluating functional neurological outcomes after IVIG or PE are lacking. Therefore with this study we aim to compare PE and IVIG as a first line treatment for patients with GBS in our setup in terms of neurological outcomes of the affected patients.

 This is a randomized parallel group trial consisting of 45 patients in each arm selected by convenient sampling and randomized via computerized random number generator, where adult patients of either sex with clinical and electrophysiological diagnosis of GBS will be included. Patients with comorbidities, those with clinical plateau of disease and those where either of the therapeutic modalities are contraindicated, will be excluded from the study. Therapy with either IVIG or PE will be started after randomization and patient will be evaluated as per GBS disability score throughout the treatment period at day 0,7,14, 28 and at 6 months. A decrease in GBS Disability scale by 1 or more points at discharge as compared to the same at admission will be considered as the outcome measure.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant Blinded

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • Clinically and electro physiologically diagnosed cases of GBS with The cases will be age and sex matched Both procedures are indicated.

排除标准

  • Patients of GBS who have achieved plateau of GBS
  • Previous episodes of GBS
  • Pregnancy
  • Severe concurrent Medical illness like TB
  • Any one of these procedures contraindicated
  • Patients whose modality of treatment has been changed from IVIG to TPE or vice versa
  • Specific exclusions with atypical features such as- a.
  • Purely sensory symptoms b.
  • Cranial nerve palsies without significant limb weakness c.
  • Improvement of one or more disability grades before inclusion.

结局指标

主要结局

A decrease in GBS Disability scale by 1 or more points at discharge as compared to the same at admission

时间窗: Patient will be evaluated as per GBS disability score throughout the treatment period and up to 6 month

次要结局

  • total cost of treatment in Indian Rupees(from the day of admission to the day of discharge)

研究者

发起方
SCB Medical College and Hospital
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Nilasish Pani

SCB Medical College and Hospital

研究点 (1)

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