Health Condition 1: G610- Guillain-Barre syndrome
Conditions
Interventions
Intervention1: Prazosin: Patients will receive tablet prazosin in a dose ranging from 7.5 mg-30 mg per day (per oral or through ryles tube) in three divided doses in addition to the standard care.
Ta
on Day 4 5 mg three times a day
on Day 8 7.5 mg three times a day
on Day 12 10 mg three times a day), till the primary endpoint is achieved or a total dose of 30 mg (10 mg three times a day, PO) daily will be reached.
In case of response, prazosin will be continued
Sponsors
AIIMS RISHIKESH
Eligibility
Inclusion criteria
Inclusion criteria: Inclusion criteria: Patients with GBS, diagnosed according to the clinical, CSF and electro-diagnostic criteria, having signs or symptoms of sympathetic over-activity based on predefined criteria will be included in this study. Diagnostic criteria for sympathetic over-activity (SO) Sympathetic overactivity (SO) was considered when any of the following four features will be present for two consecutive days: (1) sustained hypertension defined as systolic BP = 150mm of Hg and/or diastolic BP =100mm of Hg; or (2) persistent tachycardia as daily mean HR of = 125 bpm (Transient tachycardia and bradycardia were not considered as a part of autonomic dysfunction); (3) or labile BP defined as daily sustained SBP deviation = 40mm of Hg or DBP fluctuations = 20mm of Hg, (4) or labile HR defined as daily pulse changes by = 50 bpm; and, (5) along with exclusion of secondary causes such as sepsis, cardiogenic, mechanical ventilation related complications such as hypoxia or hypercapnia, pulmonary thromboembolism and hypovolemia.
Exclusion criteria
Exclusion criteria: 1.Guillain-Barre variants such as Miller-Fisher syndrome (MFS), pure sensory GBS, pharyngeal cervical brachial (PCB) variant, and facial diplegia with limb paresthesia or ataxic GBS syndromes . 2. Patients with pre-existing diabetes mellitus (DM), hypertension, coronary artery disease (CAD), , any chronic illness such as cardiac, hepatic and renal diseases . 3. already on betablocker for other clinical conditions 4. those with missing data will also be excluded. 5. Patients with hypotension ( systolic BP of less than 90mm of Hg or need for vasoactive agents, and/or bradycardia (defined as resting HR of less than 50 bpm) at admission.[ if bradycardia or hypotension occur after initiation of prazosin will not be excluded.]
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time (days) to achieve resolution of sympathetic overactivity.Timepoint: 15 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Mean fluctuation of diastolic BP at 15 days Mean fluctuation of Systolic BP at 15 days. Reduction in the mean absolute SBP and DBP at 15 days. Reduction in mean fluctuation between maximum and minimum heart rate at 15 days. Recurrence of sympathetic overactivity after withdrawal of prazosin. Adverse events such as tachycardia and hypotension after introduction of prazosin. Duration of mechanical ventilation and hospital stay. Outcome at 3 m and 6 months assessed using GBS disability scale (GBSDS; score of 0-2 scored will be considered as good outcome, and =3 as poor outcome.)Timepoint: 15 days, 3 months and 6 months | — |
Countries
India
Contacts
Public ContactMritunjai Kumar
AIIMS Rishikesh
Outcome results
None listed