Milrinone treatment versus conventional standard management for children with enterovirus 71-induced pulmonary oedema and/or neurogenic shock
| ISRCTN | ISRCTN76926623 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN76926623 |
| Secondary identifying numbers | N/A |
- Submission date
- 03/08/2010
- Registration date
- 02/09/2010
- Last edited
- 29/08/2013
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Ching-Chuan Liu
Scientific
Scientific
Pediatrics Department
No. 138 Sheng-Li Road
Tainan
70428
Taiwan
Study information
| Study design | Single centre randomised interventional treatment trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details below to request a patient information sheet |
| Scientific title | A randomised controlled trial examing the efficacy of Milrinone in reducing mortality in enterovirus 71-induced pulmonary oedema and/or neurogenic shock |
| Study objectives | 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(s) | 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) |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Phase III |
| Drug / device / biological / vaccine name(s) | 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 study start date | 01/06/2007 |
| Completion date | 31/05/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Sex | Both |
| Target number of participants | sample size 16-29 in each group |
| Key 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. |
| Key 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. |
| Date of first enrolment | 01/06/2007 |
| Date of final enrolment | 31/05/2010 |
Locations
Countries of recruitment
- Taiwan
- Viet Nam
Study participating centre
Pediatrics Department
Tainan
70428
Taiwan
70428
Taiwan
Sponsor information
National Health Research Institutes (NHRI) (Taiwan)
Research organisation
Research organisation
Division of Infectious Diseases
35 Keyan Road
Zhunan, Miaoli County
350
Taiwan
| Website | http://english.nhri.org.tw/ |
|---|---|
"ROR" |
https://ror.org/02r6fpx29 |
Funders
Funder type
Research organisation
National Health Research Institutes (NHRI) (Taiwan)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/07/2013 | Yes | No |
