Second IVIg Dose in GBS patients with poor prognosis (SID-GBS trial)

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 339

Inclusion Criteria

Patients are diagnosed with GBS.
There is an indication to start IVIg therapy:
1. Patient is unable to walk unaided for >10 meter (grade 3, 4 or 5 of the GBS disability scale) or 2. There is otherwise an indication to start IVIg treatment according to the treating neurologist.
Onset of weakness due to GBS is less than 2 weeks ago.
Signed informed consent.

Exclusion Criteria

Age less than 12 years.
Patient known to have a severe allergic reaction to properly matched blood products or plasma products.
Pregnancy or breastfeeding.
Patient known to have a selective IgA deficiency.
Patient shows clear clinical evidence of a polyneuropathy caused by e.g. diabetes mellitus (except mild sensory), alcoholism, severe vitamin deficiency, porphyria.
Patient received immunosuppressive treatment (e.g. azathioprine, cyclosporine, mycofenolaatmofetil, tacrolimus, sirolimus or > 20 mg prednisolon daily) during the last month.
Patient known to have a severe concurrent disease, like malignancy, severe cardiovascular disease, AIDS, severe CARA.
Inability to attend follow-up during 6 months.
Relative contra-indications for second IVIg dose:
Patients known to have severe kidney dysfunction (GFR below 40 ml/min).
Pre-existing risk factors of thrombo-embolic complications or severe ischemic heart disease.
Contra-indications for GPO:
proven hypersensitivity to albumin products
every situation in which hypervolaemia or haemodilution can form a special risk; examples of such conditions are: heart failure, severe hypertension, oesophageal varices, pulmonary oedema, haemorrhagic diathesis, severe anaemia, renal and postrenal anuria

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>GBS disability score at 4 weeks after start of first IVIg course. The full<br /><br>range of scores will be considered as an ordinal outcome scale. In analyzing we<br /><br>will use a proportional odds model. (Extent of) improvement on this ordinal<br /><br>scale will be compared between groups.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Percentage of patients that improve:<br /><br>at least 1, 2, 3 or 4 points on the GBS disability score at 4, 8, 12 and 26<br /><br>weeks,<br /><br>at least 4, 8 or 12 points on MRC sum score (ranging from 0-60) at 4, 8, 12<br /><br>and 26 weeks,<br /><br>at least 2, 4 or 6 points on ONLS score (ranging from 0-12) at 4, 8, 12 and<br /><br>26 weeks.<br /><br>- Percentage of patients needing artificial ventilation.<br /><br>- Time (number of days) on respirator.<br /><br>- Time (number of days) on intensive care unit.<br /><br>- Percentage of patients that die because of GBS.<br /><br>- Time (number of days) to hospital discharge.<br /><br>- Percentage of patients with secondary deterioration due to treatment-related<br /><br>fluctuations (TRF).<br /><br>- Development of complications possibly related to a second IVIg course.<br /><br>- Serum IgG levels at 5 different time points. </p><br>

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