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ISRCTN
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ISRCTN76926623
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ClinicalTrials.gov identifier
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Public title
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Milrinone treatment versus conventional standard management for children with enterovirus 71-induced pulmonary oedema and/or neurogenic shock
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Scientific title
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A randomised controlled trial examing the efficacy of Milrinone in reducing mortality in enterovirus 71-induced pulmonary oedema and/or neurogenic shock
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Acronym
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N/A
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Serial number at source
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N/A
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Study hypothesis
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The efficacy of Milrinone administered to EV71-induced pulmonary oedema and/or neurogenic shock will reduce mortality rate in acute phase (within 1 week)
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Lay summary
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Not provided at time of registration
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Ethics approval
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The ethics committee of Children's Hospital No. 1 Ho Chi Minh City (HCMC) approved on the 12th of July 2006 (ref: 4820/UBND-VX)
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Study design
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Single centre randomised interventional treatment trial
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Countries of recruitment
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Viet Nam
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Disease/condition/study domain
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Enterovirus 71-induced pulomnary oedema and/or neurogenic shock
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Participants - inclusion criteria
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1. Paediatric patients, EV71 brainstem encephalitis with pulmonary oedema and/or neurogenic shock.
2. EV71 infection was confirmed by isolation of virus or molecular test (real-time PCR) from at least one site (throat swab, stool swab, cerebrospinal fluid (CSF) or other specimens), or serologic assay (neutralizing antibody titre).
3. Stage Definitions
Stage IIIB, cardiopulmonary collapse with the occurrence of pulmonary oedema and/or neurogenic shock.
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Participants - exclusion criteria
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1. History of congenital heart disease
2. History of pulmonary disorder
3. Known or suspected impairment of immunologic function
4. Known hypersensitivity to any component of Milrinone
5. Prior administration of Milrinone
6. Any condition, which, in the opinion of the investigator, may interfere with the evaluation of the study objectives.
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Anticipated start date
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01/06/2007
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Anticipated end date
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31/05/2010
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Status of trial
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Completed |
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Patient information material
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Not available in web format, please use contact details below to request a patient information sheet
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Target number of participants
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sample size 16-29 in each group
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Interventions
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The eligible enrolled patients were randomized to receive either
1. Group A: medical (milrinone) treatment:
Milrinone (Primacor®) was administered to the subjects who met the study criteria. The drug was administered intravenously within 2-6 hours after pulmonary oedema was diagnosed at a loading dose 50ug/kg I.V. over 15 minutes followed by a continuous infusion of 0.5ug/kg/min; dosage range of 0.35-0.55ug/kg/min; titrate dose to effect. Therapy was continued for 72 hours.
2. Group B: conventional standard management (supportive acre without milrinone treatment).
All the enrolled subjects received standard medical attention with the same critical care protocol. In addition to routine biochemistry and blood counting examination on trial entry, enterovirus 71 infections were examined by isolation of virus or molecular test from throat/stool swabs or cerebro-spinal fluid (CSF) or serologic assay for neutralizing antibody titer.
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Primary outcome measure(s)
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To assess the efficacy of Milrinone as evaluated by the 1-week mortality in EV71 infected children with pulmonary oedema and/or neurogenic shock.
Each enrolled subject was followed with a standard critical care protocol until he or she was discharged from hospital or expired. Evaluation was performed when necessary for all the enrolled subjects during their hospital stays.
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Secondary outcome measure(s)
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N/A
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Sources of funding
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National Health Research Institutes (NHRI) (Taiwan)
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Trial website
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Publications
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Contact name
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Prof
Ching-Chuan
Liu
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Address
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Pediatrics Department
No. 138 Sheng-Li Road
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City/town
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Tainan
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Zip/Postcode
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70428
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Country
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Taiwan
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Sponsor
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National Health Research Institutes (NHRI) (Taiwan)
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Address
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Division of Infectious Diseases
35 Keyan Road
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City/town
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Zhunan, Miaoli County
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Zip/Postcode
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350
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Country
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Taiwan
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Sponsor website:
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http://english.nhri.org.tw/
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Date applied
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03/08/2010
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Last edited
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25/08/2011
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Date ISRCTN assigned
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02/09/2010
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