NT-proBNP and Troponin I in Dengue Children

September 20, 2023 updated by: Le Phuoc Truyen

NT-proBNP and Troponin I in Children With Dengue Hemorrhagic Shock: a Longitudinal Study

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

Treatment of children with Dengue hemorrhagic shock syndrome (DSS) is challenge, especially in cases with hypotensive shock, profound shock or whom do not have a response to initial crystalloid therapy. Currently, treatment of DSS remains almost supportive, with particular emphasis on careful fluid management. However, fluid overload is a common complication of this treatment, lead to many difficulties in management of severe Dengue children, accompany with morbidity and mortality. Diagnosis of fluid overload mostly based on clinical features and chest X-ray or ultrasound. Until now, no biomarker are widely using for diagnosis of fluid overload in clinical. NT-proBNP is secreted when stretching the wall of the cardiac muscle. This may a suitable biomarker to discover the fluid overload state in children with DSS. Troponin I is a biomarker of cardiac muscle damage.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
90

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Vietnam
      • Ho Chi Minh City, Vietnam, 700000
        • Recruiting
        • University of Medicine and Pharmacy at Ho Chi Minh City
        • Contact:
        • Principal Investigator:
          • Truyen P. Le, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

1 month to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-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 (+)

Description

Inclusion Criteria:

  • Dengue shock children who admitted to ICU

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Concentration of NT-proBNP
Time Frame: 10 days
Concentration of NT-proBNP in Children with Dengue hemorrhagic shock and severe shock
10 days
Concentration of Troponin I
Time Frame: 10 days
Concentration of Troponin I in Children with Dengue hemorrhagic shock and severe shock
10 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Cut-off value of NT-proBNP for fluid overload
Time Frame: 14 days
Cut-off value of NT-proBNP for pulmonary edema
14 days
Correlation between concentration of NT-proBNP
Time Frame: 14 days
Correlation between concentration of NT-proBNP with total fluid admission, respiratory support, using inotrope and vasopressor using
14 days
Correlation between concentration of Troponin I
Time Frame: 14 days
Correlation between concentration of Troponin I total fluid admission, respiratory support, using inotrope and vasopressor using
14 days
Rate of clinical manifestations
Time Frame: 14 days
Rate of clinical manifestations: fever, abdominal pain, petechia, hematomegaly
14 days
Rate of abnormal laboratory exam
Time Frame: 14 days
electrolyte, arterial blood gas, lactate
14 days
Rate of abnormal liver, kidney, hematology laboratory exam
Time Frame: 14 days
AST, ALT, ure, creatinin, PLT, PT, aPTT, Fibrinogen
14 days
Rate of NS1 Dengue
Time Frame: 10 days
Positive
10 days
Rate of MAC ELISA IgM Dengue
Time Frame: 14 days
Positive
14 days
Rate of complications
Time Frame: 14 days
Pulmonary edema
14 days
Rate of respiratory support
Time Frame: 14 days
Cannula, NCPAP, Intubation
14 days
Rate of intubation
Time Frame: 14 days
Positive
14 days
Rate of mode of ventilation
Time Frame: 14 days
PC, IP, PEEP, FiO2, VT
14 days
Total fluid administration
Time Frame: 14 days
ml/kg/d
14 days
Time for IV fluid administration
Time Frame: 14 days
hours
14 days
Rate and kind of cephalosporin using
Time Frame: 14 days
3rd generation cephalosporin
14 days
Rate and kind of Carbapenem using
Time Frame: 14 days
Carbapenem
14 days
Rate and kind of Vancomycin using
Time Frame: 14 days
Vancomycin
14 days
Rate of intraperitoneal fluid drainage
Time Frame: 14 days
Positive
14 days
Rate of CRRT
Time Frame: 14 days
Positive
14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Le Phuoc Truyen

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Truyen P. Le, MD, University of Medicine and Pharmacy at Ho Chi Minh City

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 2, 2021

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2023

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 3, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 7, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 8, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 22, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 20, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2130-DHYD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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