Dengue Shock SyndromeNCT04837430
NT-proBNP and Troponin I in Dengue Children
An observational study of Dengue Shock Syndrome and Children, Only, run by Le Phuoc Truyen at 1 site in Vietnam.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 month to 18 years
- Conditions the study is for
- Dengue Shock Syndrome, Children, Only
- How many people
- 90 participants
- Where
- 1 siteVietnam
- Study dates
- 2 Apr 2021to 31 Dec 2023
- How long will I take part?
- 10 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
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 (+)
Who may be able to join
- Dengue shock children who admitted to ICU
Who cannot join
- Excluding the cases of children with cardiovascular disease, hyperthyroidism, taking drugs such as insulin, steroid, estrogen, growth hormone, thyroid hormone
Trial locations and contacts
1 site in 1 country.
Vietnam1 site, 1 recruiting
- Recruiting
University of medicine and pharmacy at Ho Chi Minh city
Ho Chi Minh City, 700000
Truyen P. Le, +84 903640025, dr.letruyen@ump.edu.vn
Truyen P. Le, MD
About this study
Official title: 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.
Read the 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.
- Conditions
- Dengue Shock Syndrome, Children, Only
- Keywords
- NT-proBNP, Troponin I, Dengue children, Cardiac enzyme
- Medical subject headings
- Severe Dengue
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentration of NT-proBNP
Concentration of NT-proBNP in Children with Dengue hemorrhagic shock and severe shock
Measured: 10 days
Concentration of Troponin I
Concentration of Troponin I in Children with Dengue hemorrhagic shock and severe shock
Measured: 10 days
Secondary outcomes (19)
Cut-off value of NT-proBNP for fluid overload
Cut-off value of NT-proBNP for pulmonary edema
Measured: 14 days
Correlation between concentration of NT-proBNP
Correlation between concentration of NT-proBNP with total fluid admission, respiratory support, using inotrope and vasopressor using
Measured: 14 days
Correlation between concentration of Troponin I
Correlation between concentration of Troponin I total fluid admission, respiratory support, using inotrope and vasopressor using
Measured: 14 days
Rate of clinical manifestations
Rate of clinical manifestations: fever, abdominal pain, petechia, hematomegaly
Measured: 14 days
Rate of abnormal laboratory exam
electrolyte, arterial blood gas, lactate
Measured: 14 days
Rate of abnormal liver, kidney, hematology laboratory exam
AST, ALT, ure, creatinin, PLT, PT, aPTT, Fibrinogen
Measured: 14 days
Rate of NS1 Dengue
Positive
Measured: 10 days
Rate of MAC ELISA IgM Dengue
Positive
Measured: 14 days
Rate of complications
Pulmonary edema
Measured: 14 days
Rate of respiratory support
Cannula, NCPAP, Intubation
Measured: 14 days
Rate of intubation
Positive
Measured: 14 days
Rate of mode of ventilation
PC, IP, PEEP, FiO2, VT
Measured: 14 days
Total fluid administration
ml/kg/d
Measured: 14 days
Time for IV fluid administration
hours
Measured: 14 days
Rate and kind of cephalosporin using
3rd generation cephalosporin
Measured: 14 days
Rate and kind of Carbapenem using
Carbapenem
Measured: 14 days
Rate and kind of Vancomycin using
Vancomycin
Measured: 14 days
Rate of intraperitoneal fluid drainage
Positive
Measured: 14 days
Rate of CRRT
Positive
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2021
- Study start2 Apr 2021
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dengue Shock SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 90 participants (estimated)
- Target duration
- 10 Days
Sponsor and investigators
- Lead sponsor
- Le Phuoc Truyen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Le Phuoc Truyen, University of Medicine and Pharmacy at Ho Chi Minh City
- Investigators
- Truyen P. Le, MD, Principal investigator, University of Medicine and Pharmacy at Ho Chi Minh City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04837430
- Sponsor's protocol ID
- 2130-DHYD
- Status last verified
- Sep 2023
- First submitted
- 3 Apr 2021
- Last updated
- 22 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Le Phuoc T, Phung NTN. Serial Biomarker Monitoring Reveals Progressive Cardiac Injury in Pediatric Dengue Shock Syndrome. Pediatr Infect Dis J. 2026 Oct 1;45(10):899-904. doi: 10.1097/INF.0000000000005256. Epub 2026 Apr 30.
PubMed 42056842
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NT-proBNP and Troponin I in Children With Dengue Hemorrhagic Shock: a Longitudinal Study
- ClinicalTrials.gov ID
- NCT04837430
- Acronym / sponsor ID
- 2130-DHYD
- Conditions
- Dengue Shock Syndrome, Children, Only
- Keywords
- NT-proBNP, Troponin I, Dengue children, Cardiac enzyme
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Le Phuoc TruyenUniversity, hospital or other
- Study start
- 2 Apr 2021 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 8 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Target follow-up
- 10 Days
Who may qualify
- Ages
- 1 month to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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 (+)
Key inclusion criteria (1 listed)
- Dengue shock children who admitted to ICU
Key exclusion criteria (1 listed)
- Excluding the cases of children with cardiovascular disease, hyperthyroidism, taking drugs such as insulin, steroid, estrogen, growth hormone, thyroid hormone
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Concentration of NT-proBNP
Time frame: 10 days
Concentration of NT-proBNP in Children with Dengue hemorrhagic shock and severe shock
Concentration of Troponin I
Time frame: 10 days
Concentration of Troponin I in Children with Dengue hemorrhagic shock and severe shock
19 secondary outcomes
Cut-off value of NT-proBNP for fluid overload
Time frame: 14 days
Correlation between concentration of NT-proBNP
Time frame: 14 days
Correlation between concentration of Troponin I
Time frame: 14 days
Rate of clinical manifestations
Time frame: 14 days
Rate of abnormal laboratory exam
Time frame: 14 days
Rate of abnormal liver, kidney, hematology laboratory exam
Time frame: 14 days
Rate of NS1 Dengue
Time frame: 10 days
Rate of MAC ELISA IgM Dengue
Time frame: 14 days
Rate of complications
Time frame: 14 days
Rate of respiratory support
Time frame: 14 days
Rate of intubation
Time frame: 14 days
Rate of mode of ventilation
Time frame: 14 days
Total fluid administration
Time frame: 14 days
Time for IV fluid administration
Time frame: 14 days
Rate and kind of cephalosporin using
Time frame: 14 days
Rate and kind of Carbapenem using
Time frame: 14 days
Rate and kind of Vancomycin using
Time frame: 14 days
Rate of intraperitoneal fluid drainage
Time frame: 14 days
Rate of CRRT
Time frame: 14 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2023.
- Derived from this study: PubMed 42056842Le Phuoc T, Phung NTN. Serial Biomarker Monitoring Reveals Progressive Cardiac Injury in Pediatric Dengue Shock Syndrome. Pediatr Infect Dis J. 2026 Oct 1;45(10):899-904. doi: 10.1097/INF.0000000000005256. Epub 2026 Apr 30.
- Individual participant dataSharing planned: No
Related trials for Dengue Shock Syndrome
RecruitingPhase 1
Phase 1 Challenge Study Using rDEN2delta30-7169 to Evaluate Host-Pathogen Interactions in Primary, Homotypic, and Heterotypic Dengue Virus Infection
Healthy Volunteers, Dengue
RecruitingObservational study
Gut Leakage' in Dengue
Dengue, Dengue Hemorrhagic Fever
RecruitingObservational study
Dengvaxia US Pregnancy Registry
Dengue Virus Infection
Active, not recruitingPhase 2
Anakinra in Dengue With Hyperinflammation ( AnaDen )
Dengue, Dengue With Warning Signs
RecruitingObservational study
Risk Factors for Hospitalization and Transfusion Criteria in Patients With Dengue Virus Infection
Dengue, Dengue Fever
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Truyen P. Le, MD principal investigator
University of Medicine and Pharmacy at Ho Chi Minh City
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dengue Shock Syndrome and Children, Only, run by Le Phuoc Truyen at 1 site in Vietnam.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Le P. Truyen, MD (+84 903640025, dr.letruyen@ump.edu.vn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concentration of NT-proBNP (time frame: 10 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04837430, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2023.