Second IVIg course in Guillain-Barre syndrome patients with poor prognosis (SID-GBS trial): Protocol for a double-blind randomized, placebo-controlled clinical trial
| Autor: | Walgaard, Christa, Jacobs, Bart C., Lingsma, Hester F., Steyerberg, Ewout W., Cornblath, David R., van Doorn, Pieter A., de Wit, M. C. Y., van den Berg, B., Doets, A. Y., Leonhard, S. E., Verboon, J. C., van Woerkom, M., Tio-Gillen, A. P., van Rijs, W., Huizinga, H., Badrising, U. A., Bienfait, H. M. E., Blom, R. J., van Boheemen, C. J. M., Breukelman, A. J., Bronner, I. M., Dieks, H. J. G., van Dijk, G. W., van Engelen, B. G. M., Faber, C. G., Feenstra, B., Fokke, C., Garssen, M. P. J., Gijsbers, C. J., Gilhuis, H. J., van der Graaff, M. M., Groen, R. J., Hoogendoorn, T. A., Hovestad, A., Jansen, P. J. H. W., Jellema, K., Keuter, E., Kleyweg, R. P., van Koningsveld, R., van der Kooi, A. J., van der Kooi, E. L., Krudde, J., Kuks, J. B. M., Kuitwaard, K., Linssen, W. H. J. P., Lion, J., Lovenich, H., Manschot, S. M., Mellema, S. J., Merkies, I. S. J., van der Meulen, M. F. G., van der Meulen, W. D. M., Molenaar, D. S. M., Oenema, D. G., van Oosten, B. W., van Oostrom, J. C. H., van Orshoven, N. P., van der Ploeg, R. J. O., van der Pol, W. L., Polman, S., van der Ree, T. C., de Rijk, M. C., Ruitenberg, A., Ruts, L., Samijn, J. P. A., Schyns-Soeterboek, A. J. G. M., Stevens, M., Vermeij, F. H., Verschuuren, J. J. G. M., Visser, L. H., Wirtz, P. W., Wohlgemuth, M., Zwetsloot, C. P., Dippel, D. W. J., Hintzen, R. Q. |
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| Přispěvatelé: | Anesthesiology, Neurology, Amsterdam Neuroscience - Neuroinfection & -inflammation, AII - Infectious diseases, ANS - Neuroinfection & -inflammation, Immunology, Public Health |
| Jazyk: | angličtina |
| Rok vydání: | 2018 |
| Předmět: |
Male
IVIg Disease Guillain-Barre syndrome Disability Evaluation 0302 clinical medicine hemic and lymphatic diseases 030212 general & internal medicine Hospital Mortality Netherlands Randomized Controlled Trials as Topic treatment General Neuroscience Standard treatment Immunoglobulins Intravenous Middle Aged trial Disorders of movement Donders Center for Medical Neuroscience [Radboudumc 3] Prognosis Intensive Care Units Treatment Outcome Research Design Female Adult medicine.medical_specialty Poor prognosis Randomization Adolescent Placebo 03 medical and health sciences Young Adult All institutes and research themes of the Radboud University Medical Center Double-Blind Method Internal medicine medicine Humans Muscle Strength protocol Adverse effect Aged business.industry Patient Selection Recovery of Function Length of Stay medicine.disease Respiration Artificial Clinical trial Immunoglobulin G Neurology (clinical) business 030217 neurology & neurosurgery |
| Zdroj: | Journal of the Peripheral Nervous System Journal of the Peripheral Nervous System, 23(4), 210-215. Wiley-Blackwell Journal of the Peripheral Nervous System, 23, 4, pp. 210-215 Journal of the peripheral nervous system, 23(4), 210-215. Wiley-Blackwell Journal of the Peripheral Nervous System, 23(4), 210-215 Journal of the Peripheral Nervous System, 23(4), 210-215. Wiley-Blackwell Publishing Ltd Journal of the Peripheral Nervous System, 23, 210-215 the Dutch GBS Study Group 2018, ' Second IVIg course in Guillain-Barré syndrome patients with poor prognosis (SID-GBS trial): Protocol for a double-blind randomized, placebo-controlled clinical trial ', Journal of the Peripheral Nervous System, vol. 23, no. 4, pp. 210-215 . https://doi.org/10.1111/jns.12286 |
| ISSN: | 1085-9489 |
| Popis: | One course of intravenous immunoglobulins (IVIg) of 2 g/kg is standard treatment in Guillain-Barré 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. |
| Databáze: | OpenAIRE |
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