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临床试验/CTRI/2021/06/034242
CTRI/2021/06/034242招募中不适用

Clinical, electrophysiological spectrum and predictors of dysautonomia and successful extubation in Guillian Barre syndrome: a prospective cohort study.

未提供1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2021年6月22日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
20
试验地点
1
主要终点
proportion of patients with resolution of sympathetic hyperactivity (dysautonomia defined as

研究概览

简要总结

Guillain Barre Syndrome (GBS) is an acute flaccid quadriparesis with or without cranial nerve palsy, autonomic dysfunction and sensory loss. There are different types of GBS based on clinical and neurophysiological findings which include acute inflammatory demyelinating polyneuropathy (AIDP), acute motor axonal neuropathy (AMAN), acute motor sensory axonal neuropathy (AMSAN), Miller Fisher syndrome (MFS), Pure sensory and pan-dysautonomia variants. About one third patients develop dysautonomia which sometimes are difficult to manage. there are no proven/effective treatment for dysautonomia. like patients with scorpon bite, patients with GBS too have sympathetic over-activity which may be managed with prazosin. prazosin is an alpha blocker. this study intends to assess the spectrum of dysautonomia in patients with GBS and role of prazosin in management of dysautonomia. this is a pre-liminary study assessing the role of prazosin in dysautonomia. 

Respiratory paralysis is common in GBS and majority needs assisted ventilation. The outcome of different subtypes of GBS is different and patients on ventilators usually have poorer outcome. The triggering factors of different subtypes may be different as well as pattern of GBS may be different in different geographical locations. There is paucity of data on the severity and pattern of autonomic dysfunction and its correlation with outcome in patients with GBS. Also, there is lack of predictors of successful extubation and weaning/extubation protocol. The use of 30 min - 2 hours T-Piece trial is a well proven method (Estaban et al, 2001) of weaning in patients with ARDS. However, this has not been tested in patients with neurological diseases especially those with peripheral nerve involvement like GBS.

研究设计

研究类型
Observational

入排标准

年龄范围
12.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • Patients with GBS, based on clinical, CSF and electro-diagnostic criteria will be included in this study.
  • GBS patients with clinical evidence (defined below) of sympathetic hyperactivity will receive prazosin and titrated as per patient’s requirement.
  • clinical evidence of sympathetic hyperactivity includes cold and clammy skin (after ruling out dehydration), presence of hypertension (SBP > 140/90 mmHg) for more than 2 hours with or without pulmonary edema or Labile BP (defined as BP differences of >40mmHg in a single day) or Resting Tachycardia (> 125 beats per minute) for 2 hours.

排除标准

  • Patients with hypo or hyperkalemic paralysis, toxins, porphyria, viral myositis, MND, Cervical myelopathy and CSF cell > 50/mm3 will be excluded.
  • GBS patients with Hypotension (systolic blood pressure < 90 mmHg) and bradycardia (< 48 beats per minute) will also be excluded.

结局指标

主要结局

proportion of patients with resolution of sympathetic hyperactivity (dysautonomia defined as

时间窗: 5 days

1. SBP/DBP 140/90 mmHg.

时间窗: 5 days

2. BP variability 20 mmHg

时间窗: 5 days

3. Pulse rate 90/min without bradycardia.

时间窗: 5 days

4. resolution of pulmonary edema and other clinical signs of sympathetic over-activity

时间窗: 5 days

次要结局

  • 1. time to resolution of sympathetic over-activity(2. patients developing adverse events to prazosin eg. hypotension, brady cardia etc.)

研究者

发起方
未提供

研究点 (1)

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