Condition category
Infections and Infestations
Date applied
03/08/2010
Date assigned
02/09/2010
Last edited
29/08/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Ching-Chuan Liu

ORCID ID

Contact details

Pediatrics Department
No. 138 Sheng-Li Road
Tainan
70428
Taiwan

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 measures

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

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

http://english.nhri.org.tw/

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

Results - basic reporting

Publication summary

2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23685637

Publication citations

  1. 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.

Additional files

Editorial Notes