PMID- 30151941
OWN - NLM
STAT- MEDLINE
DCOM- 20191021
LR  - 20191022
IS  - 1529-8027 (Electronic)
IS  - 1085-9489 (Linking)
VI  - 23
IP  - 4
DP  - 2018 Dec
TI  - Second IVIg course in Guillain-Barre syndrome patients with poor prognosis 
      (SID-GBS trial): Protocol for a double-blind randomized, placebo-controlled 
      clinical trial.
PG  - 210-215
LID - 10.1111/jns.12286 [doi]
AB  - One course of intravenous immunoglobulins (IVIg) of 2 g/kg is standard treatment 
      in Guillain-Barre syndrome (GBS) patients unable to walk independently. Despite 
      treatment some patients recover poorly, in part related to rapid consumption of 
      IVIg, indicating that they may benefit from a second course of IVIg. The aim of 
      the study is to determine whether a second course of IVIg, administered 1 week 
      after start of the first course in patients with GBS and predicted poor outcome 
      improves functional outcome on the GBS disability scale after 4 weeks. Secondary 
      outcome measures include adverse events (AEs), Medical Research Council sumscore 
      and GBS disability score after 8, 12, and 26 weeks, length of hospital and ICU 
      admission, mortality, and changes in serum IgG levels. GBS patients of 12 years 
      and older with a poor prognosis, based on the modified Erasmus GBS outcome score 
      (mEGOS) at 1 week after start of the first IVIg course are eligible for 
      randomization in this double-blind, placebo-controlled (IVIg or albumin) clinical 
      trial. This study will determine if a second course of IVIg administered in the 
      acute phase of the disease is safe, feasible, and effective in patients with GBS 
      and a poor prognosis. This Dutch trial is registered prospectively as NTR 2224 in 
      the Netherlands National Trial Register (NTR) which is the Primary Registry in 
      the WHO Registry Network for the Netherlands.
CI  - (c) 2018 Peripheral Nerve Society.
FAU - Walgaard, Christa
AU  - Walgaard C
AD  - Department of Neurology, Erasmus MC University Medical Center Rotterdam, 
      Rotterdam, The Netherlands.
FAU - Jacobs, Bart C
AU  - Jacobs BC
AD  - Department of Neurology, Erasmus MC University Medical Center Rotterdam, 
      Rotterdam, The Netherlands.
AD  - Department of Immunology, Erasmus MC University Medical Center Rotterdam, 
      Rotterdam, The Netherlands.
FAU - Lingsma, Hester F
AU  - Lingsma HF
AD  - Department of Public Health, Erasmus MC University Medical Center Rotterdam, 
      Rotterdam, The Netherlands.
FAU - Steyerberg, Ewout W
AU  - Steyerberg EW
AUID- ORCID: 0000-0002-7787-0122
AD  - Department of Public Health, Erasmus MC University Medical Center Rotterdam, 
      Rotterdam, The Netherlands.
AD  - Department of Biomedical Data Sciences, LUMC, Leiden, The Netherlands.
FAU - Cornblath, David R
AU  - Cornblath DR
AD  - Department of Neurology, Johns Hopkins University, Baltimore, Maryland.
FAU - van Doorn, Pieter A
AU  - van Doorn PA
AD  - Department of Neurology, Erasmus MC University Medical Center Rotterdam, 
      Rotterdam, The Netherlands.
CN  - Dutch GBS Study Group
LA  - eng
GR  - WAR07-28/Prinses Beatrix Spierfonds/International
GR  - Sanquin plasma products/International
PT  - Clinical Trial Protocol
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20180924
PL  - United States
TA  - J Peripher Nerv Syst
JT  - Journal of the peripheral nervous system : JPNS
JID - 9704532
RN  - 0 (Immunoglobulin G)
RN  - 0 (Immunoglobulins, Intravenous)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Aged
MH  - Disability Evaluation
MH  - Double-Blind Method
MH  - Female
MH  - Guillain-Barre Syndrome/blood/epidemiology/*therapy
MH  - Hospital Mortality
MH  - Humans
MH  - Immunoglobulin G/blood
MH  - Immunoglobulins, Intravenous/*administration & dosage/therapeutic use
MH  - Intensive Care Units/statistics & numerical data
MH  - Length of Stay
MH  - Male
MH  - Middle Aged
MH  - Muscle Strength
MH  - Netherlands/epidemiology
MH  - Patient Selection
MH  - Prognosis
MH  - Randomized Controlled Trials as Topic/*methods
MH  - Recovery of Function
MH  - Research Design
MH  - Respiration, Artificial/statistics & numerical data
MH  - Treatment Outcome
MH  - Young Adult
OTO - NOTNLM
OT  - Guillain-Barre syndrome
OT  - IVIg
OT  - protocol
OT  - treatment
OT  - trial
FIR - van Doorn, P A
IR  - van Doorn PA
FIR - Jacobs, B C
IR  - Jacobs BC
FIR - Walgaard, C
IR  - Walgaard C
FIR - de Wit, M C Y
IR  - de Wit MCY
FIR - Steyerberg, E W
IR  - Steyerberg EW
FIR - Cornblath, D R
IR  - Cornblath DR
FIR - van den Berg, B
IR  - van den Berg B
FIR - Doets, A Y
IR  - Doets AY
FIR - van Doorn, P A
IR  - van Doorn PA
FIR - Jacobs, B C
IR  - Jacobs BC
FIR - Leonhard, S E
IR  - Leonhard SE
FIR - Verboon, J C
IR  - Verboon JC
FIR - Walgaard, C
IR  - Walgaard C
FIR - van Woerkom, M
IR  - van Woerkom M
FIR - Tio-Gillen, A P
IR  - Tio-Gillen AP
FIR - van Rijs, W
IR  - van Rijs W
FIR - Huizinga, H
IR  - Huizinga H
FIR - Badrising, U A
IR  - Badrising UA
FIR - Bienfait, H M E
IR  - Bienfait HME
FIR - Blom, R J
IR  - Blom RJ
FIR - van Boheemen, C J M
IR  - van Boheemen CJM
FIR - Breukelman, A J
IR  - Breukelman AJ
FIR - Bronner, I M
IR  - Bronner IM
FIR - Dieks, H J G
IR  - Dieks HJG
FIR - van Dijk, G W
IR  - van Dijk GW
FIR - van Engelen, B G M
IR  - van Engelen BGM
FIR - Faber, C G
IR  - Faber CG
FIR - Feenstra, B
IR  - Feenstra B
FIR - Fokke, C
IR  - Fokke C
FIR - Garssen, M P J
IR  - Garssen MPJ
FIR - Gijsbers, C J
IR  - Gijsbers CJ
FIR - Gilhuis, H J
IR  - Gilhuis HJ
FIR - van der Graaff, M M
IR  - van der Graaff MM
FIR - Groen, R J
IR  - Groen RJ
FIR - Hoogendoorn, T A
IR  - Hoogendoorn TA
FIR - Hovestad, A
IR  - Hovestad A
FIR - Jansen, P J H W
IR  - Jansen PJHW
FIR - Jellema, K
IR  - Jellema K
FIR - Keuter, E
IR  - Keuter E
FIR - Kleyweg, R P
IR  - Kleyweg RP
FIR - van Koningsveld, R
IR  - van Koningsveld R
FIR - van der Kooi, A J
IR  - van der Kooi AJ
FIR - van der Kooi, E L
IR  - van der Kooi EL
FIR - Krudde, J
IR  - Krudde J
FIR - Kuks, J B M
IR  - Kuks JBM
FIR - Kuitwaard, K
IR  - Kuitwaard K
FIR - Linssen, W H J P
IR  - Linssen WHJP
FIR - Lion, J
IR  - Lion J
FIR - Lovenich, H
IR  - Lovenich H
FIR - Manschot, S M
IR  - Manschot SM
FIR - Mellema, S J
IR  - Mellema SJ
FIR - Merkies, I S J
IR  - Merkies ISJ
FIR - van der Meulen, M F G
IR  - van der Meulen MFG
FIR - van der Meulen, W D M
IR  - van der Meulen WDM
FIR - Molenaar, D S M
IR  - Molenaar DSM
FIR - Oenema, D G
IR  - Oenema DG
FIR - van Oosten, B W
IR  - van Oosten BW
FIR - van Oostrom, J C H
IR  - van Oostrom JCH
FIR - van Orshoven, N P
IR  - van Orshoven NP
FIR - van der Ploeg, R J O
IR  - van der Ploeg RJO
FIR - van der Pol, W L
IR  - van der Pol WL
FIR - Polman, S
IR  - Polman S
FIR - van der Ree, T C
IR  - van der Ree TC
FIR - de Rijk, M C
IR  - de Rijk MC
FIR - Ruitenberg, A
IR  - Ruitenberg A
FIR - Ruts, L
IR  - Ruts L
FIR - Samijn, J P A
IR  - Samijn JPA
FIR - Schyns-Soeterboek, A J G M
IR  - Schyns-Soeterboek AJGM
FIR - Stevens, M
IR  - Stevens M
FIR - Vermeij, F H
IR  - Vermeij FH
FIR - Verschuuren, J J G M
IR  - Verschuuren JJGM
FIR - Visser, L H
IR  - Visser LH
FIR - Wirtz, P W
IR  - Wirtz PW
FIR - Wohlgemuth, M
IR  - Wohlgemuth M
FIR - Zwetsloot, C P
IR  - Zwetsloot CP
FIR - Lingsma, H F
IR  - Lingsma HF
FIR - Steyerberg, E W
IR  - Steyerberg EW
FIR - Dippel, D W J
IR  - Dippel DWJ
FIR - Hintzen, R Q
IR  - Hintzen RQ
EDAT- 2018/08/29 06:00
MHDA- 2019/10/23 06:00
CRDT- 2018/08/29 06:00
PHST- 2018/08/01 00:00 [received]
PHST- 2018/08/21 00:00 [accepted]
PHST- 2018/08/29 06:00 [pubmed]
PHST- 2019/10/23 06:00 [medline]
PHST- 2018/08/29 06:00 [entrez]
AID - 10.1111/jns.12286 [doi]
PST - ppublish
SO  - J Peripher Nerv Syst. 2018 Dec;23(4):210-215. doi: 10.1111/jns.12286. Epub 2018 
      Sep 24.