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CTRI Number  CTRI/2021/06/034242 [Registered on: 15/06/2021] Trial Registered Prospectively
Last Modified On: 27/06/2021
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Single Arm Study 
Public Title of Study   clinical profile of autonomic dysfunction and mechanical ventilation in Guillian Barre syndrome 
Scientific Title of Study   Clinical, electrophysiological spectrum and predictors of dysautonomia and successful extubation in Guillian Barre syndrome: a prospective cohort study. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Mritunjai Kumar  
Designation  Assistant Professor 
Affiliation  all india institute of medical sciences, Rishikesh 
Address  Department of neurology AIIMS Rishikesh Dehradun UTTARANCHAL 249203 India

Dehradun
UTTARANCHAL
249203
India 
Phone  9997010096  
Fax    
Email  mritunjaisingh68@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Mritunjai Kumar  
Designation  Assistant Professor 
Affiliation  all india institute of medical sciences, Rishikesh 
Address  Department of neurology AIIMS Rishikesh Dehradun UTTARANCHAL 249203 India


UTTARANCHAL
249203
India 
Phone  9997010096  
Fax    
Email  mritunjaisingh68@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Mritunjai Kumar  
Designation  Assistant Professor 
Affiliation  all india institute of medical sciences, Rishikesh 
Address  Department of neurology AIIMS Rishikesh Dehradun UTTARANCHAL 249203 India


UTTARANCHAL
249203
India 
Phone  9997010096  
Fax    
Email  mritunjaisingh68@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of medical sciences, Rishikesh 
 
Primary Sponsor  
Name  NIL 
Address  NIL 
Type of Sponsor  Other [nil] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
mritunjai kumar  AIIMS RISHIKESH  Department of Neurology
Dehradun
UTTARANCHAL 		 9997010096

mritunjaisingh68@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
AIIMS RISHIKESH  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G00-G99||Diseases of the nervous system,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  nil  nil 
Comparator Agent  nil  nil 
 
Inclusion Criteria  
Age From  12.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  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.
 
 
ExclusionCriteria 
Details  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.  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
proportion of patients with resolution of sympathetic hyperactivity (dysautonomia defined as
1. SBP/DBP 140/90 mmHg.
2. BP variability 20 mmHg
3. Pulse rate 90/min without bradycardia.
4. resolution of pulmonary edema and other clinical signs of sympathetic over-activity 		 5 days 
 
Secondary Outcome  
Outcome  TimePoints 
1. time to resolution of sympathetic over-activity
2. patients developing adverse events to prazosin eg. hypotension, brady cardia etc.
3. disability at 1, 3 and 6 months assessed by Hughes disability scale.
4. proportion of patients succesfully completing 48 hour T-Piece trial.
5. proportion of patients with failed extubation.
6. spectrum of dysautonomia in GBS patients.  		 6 month 
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="20" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   22/06/2021 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response (Others) -  upon reasonable request

  6. For how long will this data be available start date provided 28-12-2024 and end date provided 27-12-2029?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary   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.
 
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