Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
A randomised controlled trial examing the efficacy of Milrinone in reducing mortality in enterovirus 71-induced pulmonary oedema and/or neurogenic shock
Acronym
Study hypothesis
The efficacy of Milrinone administered to EV71-induced pulmonary oedema and/or neurogenic shock will reduce mortality rate in acute phase (within 1 week)
Ethics approval
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)
Study design
Single centre randomised interventional treatment trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use contact details below to request a patient information sheet
Condition
Enterovirus 71-induced pulomnary oedema and/or neurogenic shock
Intervention
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.
Intervention type
Drug
Phase
Phase III
Drug names
Milrinone (Primacor®)
Primary outcome measure
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.
Secondary outcome measures
N/A
Overall trial start date
01/06/2007
Overall trial end date
31/05/2010
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
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.
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
sample size 16-29 in each group
Participant exclusion criteria
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.
Recruitment start date
01/06/2007
Recruitment end date
31/05/2010
Locations
Countries of recruitment
Viet Nam
Trial participating centre
Pediatrics Department
Tainan
70428
Taiwan
Sponsor information
Organisation
National Health Research Institutes (NHRI) (Taiwan)
Sponsor details
Division of Infectious Diseases
35 Keyan Road
Zhunan
Miaoli County
350
Taiwan
Sponsor type
Research organisation
Website
Funders
Funder type
Research organisation
Funder name
National Health Research Institutes (NHRI) (Taiwan)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23685637
Publication citations
-
Results
Chi CY, Khanh TH, Thoa le PK, Tseng FC, Wang SM, Thinh le Q, Lin CC, Wu HC, Wang JR, Hung NT, Thuong TC, Chang CM, Su IJ, Liu CC, Milrinone therapy for enterovirus 71-induced pulmonary edema and/or neurogenic shock in children: a randomized controlled trial., Crit. Care Med., 2013, 41, 7, 1754-1760, doi: 10.1097/CCM.0b013e31828a2a85.