Intravenous Immunoglobulin (IVIG) Versus Plasma Exchange (PE) for Ventilated Children With Guillain Barre Syndrome (GBS)
NCT ID: NCT01306578
Last Updated: 2011-03-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
41 participants
INTERVENTIONAL
2007-01-31
2010-02-28
Brief Summary
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Detailed Description
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Cases were diagnosed according to clinical criteria. The decisions to initiate, wean and terminate mechanical ventilation were made independently by the attending consultant in accordance with the unit guidelines.
Outcome variables measured were duration of mechanical ventilation, length of PICU stay and ability to walk unaided 4 weeks after PICU discharge.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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IVIG group
20 children randomized to receive IVIG for 5 days at a dose of 0.4 g/kg/day
IVIG
Intravenous Immune Globulin at a dose 0f 0.4 g/kg/day for 5 consecutive days
Plasma Exchange
21 children randomized to receive 5 sessions of 1 volume plasma exchange per day for 5 consecutive days
Plasma Exchange
Five sessions of plasma exchange, single plasma volume each, for 5 consecutive days
Interventions
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IVIG
Intravenous Immune Globulin at a dose 0f 0.4 g/kg/day for 5 consecutive days
Plasma Exchange
Five sessions of plasma exchange, single plasma volume each, for 5 consecutive days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Clinical diagnosis of Guillain Barre syndrome
* Requirement of mechanical ventilation
Exclusion Criteria
* Child receiving IVIG or PE prior to enrollment
1 Month
18 Months
ALL
No
Sponsors
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Mansoura University Children Hospital
OTHER
Responsible Party
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Head of PICU - Mansoura University Children Hospital
Principal Investigators
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Mohammed A El-Bayoumi, MD, FRCPCH
Role: PRINCIPAL_INVESTIGATOR
Head of PICU, Mansoura University Children Hospital
Locations
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Mansoura University Children Hospital
Al Mansurah, Dakahlia Governorate, Egypt
Countries
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References
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Saleh M, Boukhdoud M, Boukhdoud H, Al Zein M, Salameh P. Landscape of Guillain-Barre Syndrome Interventional Clinical Trials. J Clin Neuromuscul Dis. 2023 Mar 1;24(3):119-129. doi: 10.1097/CND.0000000000000441.
El-Bayoumi MA, El-Refaey AM, Abdelkader AM, El-Assmy MM, Alwakeel AA, El-Tahan HM. Comparison of intravenous immunoglobulin and plasma exchange in treatment of mechanically ventilated children with Guillain Barre syndrome: a randomized study. Crit Care. 2011 Jul 11;15(4):R164. doi: 10.1186/cc10305.
Other Identifiers
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MUCH-GBS
Identifier Type: -
Identifier Source: org_study_id
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