Clinical Trial: Small Volume Plasma Exchange (SVPE) for Guillain-Barré Syndrome (GBS) Patients
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: Small Volume Plasma Exchange (SVPE) for Guillain-Barré Syndrome Patients in Bangladesh: A Safety and Feasibility Study
Brief Summary: Guillain-Barré syndrome (GBS) is the commonest form of acute flaccid paralysis and the incidence is high in low-income countries. In Bangladesh, most GBS patients are poor. Therefore patients cannot afford expensive specific treatments like intravenous immunoglobulin (IVIg) or plasmapheresis (PE) in part explaining the high mortality and disability compared to treated patients in high-income countries. Added difficulty in traditional PE is its unavailability and specialized device and manpower dependency. Most research in GBS has been conducted in high-income countries, largely in patients with a demyelinating form of GBS. Axonal form of GBS is common in low-income and Asian countries which has a different pathogenesis, clinical course and outcome than the demyelinating form. Very few therapeutic studies have been conducted in low-income countries due to expensive existing modalities of treatment. Here, the investigators propose SVPE as a treatment for GBS in patients from low-income countries. SVPE is relatively cheap, can be done at the bedside without any special device or electricity and eventually is expected to help poor severely affected GBS patients in underdeveloped and developing countries. The main outcomes will be the safety and feasibility of SVPE since this is yet to be established in the resource limited settings. To be able to evaluate the safety of SVPE, additional information will be acquired about the frequency of complications in non-GBS patients with a central line, treated during the same time period at the same study facility as the GBS patients. Severe sepsis due to central line associated blood stream infection and deep venous thrombosis in the limb where the central venous catheter will be inserted during or following the SVPE procedure, will be defined as severe adverse effect (SAE) and will be considered as primary outcome measure for safety. Blood, cerebrospinal fluid and other relevant biological specimens will be analysed for diag
Detailed Summary:
Study design:
In this safety and feasibility study, 20 GBS patients will be enrolled for SVPE as per protocol criteria. Clinometric measurements (heart rate, blood pressure, temperature, oxygen saturation (SpO2), neurological examination) along with documentation of central line associated blood stream infection (CLABSI) and other complications related to central venous (CV) catheter will be conducted daily and throughout the course of SVPE until the 2nd day of the withdrawal of the CV catheter according to a predefined protocol. Diagnosed or strongly suspected CLABSI and central venous catheter related deep venous thrombosis (DVT) will be followed up for definite outcome to determine the frequency of severe adverse events attributed to CLABSI until the patient discharges from the hospital. Neurological outcome will be documented according to several disability assessment scales throughout the SVPE until discharge and up to four weeks from the enrollment of the GBS patients. In addition, the safety of the SVPE in GBS patients will be compared with the background complication risk by determining the frequency of complications in non-GBS patients treated with a CV catheter at the same intensive care unit (ICU) during the same period using the same protocol for surveillance as in SVPE-treated GBS patients.
SVPE kit:
SVPE kit will be prepared with one blood transfusion set and two saline infusion sets connected with a tri channel device. On the other end the blood transfusion set will be connected with the blood bag, one saline infusion set is connected with 1 liter normal saline mixed with 2500 unit of un fractionated heparin and one saline infusion set is connected with 500 ml hexa-ethyl starch solution. All the tubes should be made air free by fluid column from respective ba
Sponsor: International Centre for Diarrhoeal Disease Research, Bangladesh
Current Primary Outcome:
- Number of participants in whom up to eight liters of plasma could be removed [ Time Frame: 8 days ]
- Number of participants who complete forty sessions of SVPE [ Time Frame: 8 days ]
- Number of patients developing severe sepsis or septic shock due to CLABSI in SVPE treated GBS patients [ Time Frame: 8 days ]
- Number of patients with venous thrombosis in the limb where the central venous catheter [ Time Frame: 8 days ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Proportion of central venous catheter blockade that requires catheter replacement. [ Time Frame: 8 days ]
- Required education time (in days) to acquire expertise to do the SVPE procedure by the responsible staff doctors and nurses [ Time Frame: 8 days ]
- Relative risk of CLABSI due to SVPE compared to CLABSI in non-GBS patients treated with a central line at the same ICU [ Time Frame: 8 days ]
- Variations of systolic blood pressure greater than 30mm Hg within 30 minutes after starting SVPE [ Time Frame: 30 minutes ]
- Proportion of participants in whom SVPE had to be discontinued due to poor hemodynamic tolerance or other side effects and the exact time of discontinuation of the SVPE procedure [ Time Frame: 8 days ]
- Development of anaemia (Hb <7 gm./dl) or haemorrhage requiring blood transfusion. [ Time Frame: 8 days ]
- Sudden bradycardia involving a reduction of heart rate by more than 20 beats per minute within 30 minutes after starting SVPE [ Time Frame: 30 minutes ]
- Rise in heart rate above 120 beats per minute within 30 minutes after starting SVPE [ Time Frame: 30 minutes ]
- Improvement by one or more grades in GBS disability score [ Time Frame: 4 weeks ]
GBS disability score is graded on a scale of 0 - 6
0: A healthy state
- Minor symptoms and capable of running
- Able to walk 10 meters or more without assistance but unable to run
- Able to walk 10 meters across an open space with help
- Bedridden or chair bound
- Requiring assisted ventilation for at least part of the day
- Dead
Original Secondary Outcome: Same as current
Information By: International Centre for Diarrhoeal Disease Research, Bangladesh
Dates:
Date Received: April 10, 2016
Date Started: January 2016
Date Completion: March 2017
Last Updated: February 22, 2017
Last Verified: May 2016
