Back to resultsIntravenous Immunoglobulin (IVIG) Versus Plasma Exchange (PE) for Ventilated Children With Guillain Barre Syndrome (GBS)
Primary Purpose
Guillain Barre Syndrome
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
IVIG
Plasma Exchange
Sponsored by
About this trial
This is an interventional treatment trial for Guillain Barre Syndrome focused on measuring Guillain Barre syndrome, IVIG, Plasma exchange
Eligibility Criteria
Inclusion Criteria:
- Age: children from 1 month - 18 years old
- Clinical diagnosis of Guillain Barre syndrome
- Requirement of mechanical ventilation
Exclusion Criteria:
- Need for mechanical ventilation beyond 14 days from disease onset
- Child receiving IVIG or PE prior to enrollment
Sites / Locations
- Mansoura University Children Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
IVIG group
Plasma Exchange
Arm Description
20 children randomized to receive IVIG for 5 days at a dose of 0.4 g/kg/day
21 children randomized to receive 5 sessions of 1 volume plasma exchange per day for 5 consecutive days
Outcomes
Primary Outcome Measures
Duration of mechanical ventilation
How many days did the mechanical ventilation continue
Secondary Outcome Measures
PICU stay
How many days did the child spend on PICU
Ability to walk
Ability of the child to walk unaided at 4 weeks from PICU admission
Full Information
NCT ID
NCT01306578
First Posted
March 1, 2011
Last Updated
March 1, 2011
Sponsor
Mansoura University Children Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01306578
Brief Title
Intravenous Immunoglobulin (IVIG) Versus Plasma Exchange (PE) for Ventilated Children With Guillain Barre Syndrome (GBS)
Official Title
Comparison of Intravenous Immunoglobulin and Plasma Exchange in Treatment of Mechanically Ventilated Children With Guillain Barre Syndrome. A Randomized Study.
Study Type
Interventional
2. Study Status
Record Verification Date
February 2011
Overall Recruitment Status
Completed
Study Start Date
January 2007 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
February 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Mansoura University Children Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Comparing whether intravenous immune globulin or plasma exchange is superior in treating mechanically ventilated children with Guillain Barre syndrome.
Detailed Description
Children with Guillain Barre syndrome (GBS) admitted to PICU at Mansoura University Children Hospital, Mansoura, Egypt with the need for mechanical ventilation were prospectively enrolled in the study.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Guillain Barre Syndrome
Keywords
Guillain Barre syndrome, IVIG, Plasma exchange
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
41 (Actual)
8. Arms, Groups, and Interventions
Arm Title
IVIG group
Arm Type
Active Comparator
Arm Description
20 children randomized to receive IVIG for 5 days at a dose of 0.4 g/kg/day
Arm Title
Plasma Exchange
Arm Type
Active Comparator
Arm Description
21 children randomized to receive 5 sessions of 1 volume plasma exchange per day for 5 consecutive days
Intervention Type
Drug
Intervention Name(s)
IVIG
Other Intervention Name(s)
Sandglobin
Intervention Description
Intravenous Immune Globulin at a dose 0f 0.4 g/kg/day for 5 consecutive days
Intervention Type
Procedure
Intervention Name(s)
Plasma Exchange
Other Intervention Name(s)
Plasmapheresis
Intervention Description
Five sessions of plasma exchange, single plasma volume each, for 5 consecutive days
Primary Outcome Measure Information:
Title
Duration of mechanical ventilation
Description
How many days did the mechanical ventilation continue
Time Frame
21 days (average)
Secondary Outcome Measure Information:
Title
PICU stay
Description
How many days did the child spend on PICU
Time Frame
28 days (average)
Title
Ability to walk
Description
Ability of the child to walk unaided at 4 weeks from PICU admission
Time Frame
4 weeks from PICU discharge
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Month
Maximum Age & Unit of Time
18 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age: children from 1 month - 18 years old
Clinical diagnosis of Guillain Barre syndrome
Requirement of mechanical ventilation
Exclusion Criteria:
Need for mechanical ventilation beyond 14 days from disease onset
Child receiving IVIG or PE prior to enrollment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohammed A El-Bayoumi, MD, FRCPCH
Organizational Affiliation
Head of PICU, Mansoura University Children Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mansoura University Children Hospital
City
Mansoura
State/Province
Dakahlia
Country
Egypt
12. IPD Sharing Statement
Citations:
PubMed Identifier
21745374
Citation
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.
Results Reference
derived
Learn more about this trial
Intravenous Immunoglobulin (IVIG) Versus Plasma Exchange (PE) for Ventilated Children With Guillain Barre Syndrome (GBS)
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