Guillain-Barre syndrome
Conditions
Interventions
Second IVIg dose or placebo in selected patientgroup with a poor prognosis.
Sponsors
Erasmus MC Rotterdam
Eligibility
Inclusion criteria
Inclusion criteria: To enter this GBS study: 1. Patients are diagnosed with GBS[30]; 2. There is an indication to start IVIg (irrespective of co-treatment with methylprednisolon (MP)) therapy: A. Patient is unable to walk unaided for >10 meter (grade 3, 4 or 5 of the GBS disability scale), or; B. There is otherwise an indication to start IVIg (with or without MP) treatment according to the treating neurologist. 3. Onset of weakness due to GBS is less than 2 weeks ago; 4. Signed informed consent. To be randomized in the second IVIg dose phase (RCT), patients must fulfill the following criteria: 1. First IVIg (with or without MP) treatment with Nanogam® started within 2 weeks from onset of weakness; 2. IVIg treatment has been 2g/kg administered in 2-5 days; 3. Poor prognosis based upon the modified EGOS (mEGOS 6-12) at day 7 after start of first IVIg treatment.
Exclusion criteria
Exclusion criteria: 1. Age less than 6 years; 2. Patient known to have a severe allergic reaction to properly matched blood products or plasma products; 3. Pregnancy or breastfeeding; 4. Patient known to have a selective IgA deficiency; 5. Patient shows clear clinical evidence of a polyneuropathy caused by e.g. diabetes mellitus (except mild sensory), alcoholism, severe vitamin deficiency, porphyria; 6. Patient received immunosuppressive treatment (e.g. azathioprine, cyclosporine, mycofenolaatmofetil, tacrolimus, sirolimus or > 20 mg prednisolon daily) during the last month; 7. Patient known to have a severe concurrent disease, like malignancy, severe cardiovascular disease, AIDS, severe CARA; 8. Inability to attend follow-up during 6 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine whether a second IVIg dosage in GBS patients with a poor prognosis improve functional outcome after 4 weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| To investigate whether: 1. A second IVIg dosage in GBS patients with a poor prognosis improve functional outcome or muscle strength after 8, 12 and 26 weeks; 2. A second IVIg dosage in GBS patients with a poor prognosis lowers the percentage of patients needing artificial ventilation, lower the time (number of days) on respirator or time on the intensive care; 3. A second IVIg dosage in GBS patients with a poor prognosis reduces the time to hospital discharge; 4. A second IVIg dosage in GBS patients with a poor prognosis reduce the chance of secondary deterioration due to treatment-related fluctuations (TRF†); 5. Patients treated with a second IVIg dosage develop more complications possibly related to the second IVIg treatment; 6. A second IVIg dosage in GBS patients with a poor prognosis lowers the percentage of patients that die because of GBS; 7. The serum IgG increase after the first IVIg dosage is lower in patients with a poor prognosis; 8. Serum IgG increases further (and to what extent) after administration of a second IVIg dosage. | — |
Contacts
Public ContactChrista Walgaard
Postbus 1738
Outcome results
None listed