NCT04837430

Brief Summary

To discribe concentration of NT-proBNP and Troponin I in Dengue hemorrhagic shock children, in correlation between concentration of NT-proBNP and troponin I with total fluid admission, respiratory support, using inotrope and vasopressor using.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 2, 2021

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

April 3, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 8, 2021

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

September 22, 2023

Status Verified

September 1, 2023

Enrollment Period

2.7 years

First QC Date

April 3, 2021

Last Update Submit

September 20, 2023

Conditions

Dengue Shock SyndromeChildren, Only

Keywords

NT-proBNPTroponin IDengue childrenCardiac enzyme

Outcome Measures

Primary Outcomes (2)

  • Concentration of NT-proBNP

    Concentration of NT-proBNP in Children with Dengue hemorrhagic shock and severe shock

    10 days

  • Concentration of Troponin I

    Concentration of Troponin I in Children with Dengue hemorrhagic shock and severe shock

    10 days

Secondary Outcomes (19)

  • Cut-off value of NT-proBNP for fluid overload

    14 days

  • Correlation between concentration of NT-proBNP

    14 days

  • Correlation between concentration of Troponin I

    14 days

  • Rate of clinical manifestations

    14 days

  • Rate of abnormal laboratory exam

    14 days

  • +14 more secondary outcomes

Eligibility Criteria

Age1 Month - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Children from 1 month to 15 years old are diagnosed with Dengue shock syndrome according to guidelines of WHO with NS1 (+) or ELISA IgM Dengue (+)

You may qualify if:

  • Dengue shock children who admitted to ICU

You may not qualify if:

  • Excluding the cases of children with cardiovascular disease, hyperthyroidism, taking drugs such as insulin, steroid, estrogen, growth hormone, thyroid hormone

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of medicine and pharmacy at Ho Chi Minh city

Ho Chi Minh City, 700000, Vietnam

RECRUITING

MeSH Terms

Conditions

Severe Dengue

Condition Hierarchy (Ancestors)

DengueMosquito-Borne DiseasesVector Borne DiseasesInfectionsArbovirus InfectionsVirus DiseasesFlavivirus InfectionsFlaviviridae InfectionsRNA Virus InfectionsHemorrhagic Fevers, Viral

Study Officials

  • Truyen P. Le, MD

    University of Medicine and Pharmacy at Ho Chi Minh City

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Le P. Truyen, MD

CONTACT

+84 903640025dr.letruyen@ump.edu.vn

Phung Nguyen, MD

CONTACT

84 989043858nguyenphung@ump.edu.vn

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
PROSPECTIVE
Target Duration
10 Days
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Clinical Physician

Study Record Dates

First Submitted

April 3, 2021

First Posted

April 8, 2021

Study Start

April 2, 2021

Primary Completion

December 31, 2023

Study Completion

December 31, 2023

Last Updated

September 22, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations

VN(1)