Clinical trial NCT04837430: NT-proBNP and Troponin I in Dengue Children
Official title: NT-proBNP and Troponin I in Children With Dengue Hemorrhagic Shock: a Longitudinal Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Dengue Shock Syndrome
Children, Only
Keywords: NT-proBNP
Troponin I
Dengue children
Cardiac enzyme
Lead sponsor: University of Medicine and Pharmacy at Ho Chi Minh City
Sponsor class: OTHER
First posted: 2021-04-08
Enrollment: 90
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
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 (+)

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Concentration of NT-proBNP
timeFrame: 10 days
measure: Concentration of Troponin I
timeFrame: 10 days
Secondary outcomes:
measure: Cut-off value of NT-proBNP for fluid overload
timeFrame: 14 days
measure: Correlation between concentration of NT-proBNP
timeFrame: 14 days
measure: Correlation between concentration of Troponin I
timeFrame: 14 days
measure: Rate of clinical manifestations
timeFrame: 14 days
measure: Rate of abnormal laboratory exam
timeFrame: 14 days
measure: Rate of abnormal liver, kidney, hematology laboratory exam
timeFrame: 14 days
measure: Rate of NS1 Dengue
timeFrame: 10 days
measure: Rate of MAC ELISA IgM Dengue
timeFrame: 14 days
measure: Rate of complications
timeFrame: 14 days
measure: Rate of respiratory support
timeFrame: 14 days
measure: Rate of intubation
timeFrame: 14 days
measure: Rate of mode of ventilation
timeFrame: 14 days
measure: Total fluid administration
timeFrame: 14 days
measure: Time for IV fluid administration
timeFrame: 14 days
measure: Rate and kind of cephalosporin using
timeFrame: 14 days
measure: Rate and kind of Carbapenem using
timeFrame: 14 days
measure: Rate and kind of Vancomycin using
timeFrame: 14 days
measure: Rate of intraperitoneal fluid drainage
timeFrame: 14 days
measure: Rate of CRRT
timeFrame: 14 days
Other outcomes:
Locations:
city: Ho Chi Minh City
country: Vietnam
facility: University of medicine and pharmacy at Ho Chi Minh city
Study officials:
affiliation: University of Medicine and Pharmacy at Ho Chi Minh City
name: Truyen P. Le, MD
role: PRINCIPAL_INVESTIGATOR
References: