NT-proBNP and Troponin I in Dengue Children

Children, Only Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04837430
• Other study ID #: 2130-DHYD
• Status: Recruiting
• Start date: April 2, 2021
• Est. completion date: December 31, 2023

Study information

• Verified date: September 2023
• Source: University of Medicine and Pharmacy at Ho Chi Minh City
• Contact: Le P. Truyen, MD
• Phone: +84 903640025
• Email: dr.letruyen[@]ump.edu.vn
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Month to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Children, Only
• Dengue
• Dengue Shock Syndrome
• Severe Dengue
• Shock

Locations

Country	Name	City	State
Vietnam	University of medicine and pharmacy at Ho Chi Minh city	Ho Chi Minh City

Sponsors (1)

Lead Sponsor	Collaborator
Le Phuoc Truyen

Country where clinical trial is conducted

Vietnam, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Concentration of NT-proBNP	Concentration of NT-proBNP in Children with Dengue hemorrhagic shock and severe shock	10 days
Primary	Concentration of Troponin I	Concentration of Troponin I in Children with Dengue hemorrhagic shock and severe shock	10 days
Secondary	Cut-off value of NT-proBNP for fluid overload	Cut-off value of NT-proBNP for pulmonary edema	14 days
Secondary	Correlation between concentration of NT-proBNP	Correlation between concentration of NT-proBNP with total fluid admission, respiratory support, using inotrope and vasopressor using	14 days
Secondary	Correlation between concentration of Troponin I	Correlation between concentration of Troponin I total fluid admission, respiratory support, using inotrope and vasopressor using	14 days
Secondary	Rate of clinical manifestations	Rate of clinical manifestations: fever, abdominal pain, petechia, hematomegaly	14 days
Secondary	Rate of abnormal laboratory exam	electrolyte, arterial blood gas, lactate	14 days
Secondary	Rate of abnormal liver, kidney, hematology laboratory exam	AST, ALT, ure, creatinin, PLT, PT, aPTT, Fibrinogen	14 days
Secondary	Rate of NS1 Dengue	Positive	10 days
Secondary	Rate of MAC ELISA IgM Dengue	Positive	14 days
Secondary	Rate of complications	Pulmonary edema	14 days
Secondary	Rate of respiratory support	Cannula, NCPAP, Intubation	14 days
Secondary	Rate of intubation	Positive	14 days
Secondary	Rate of mode of ventilation	PC, IP, PEEP, FiO2, VT	14 days
Secondary	Total fluid administration	ml/kg/d	14 days
Secondary	Time for IV fluid administration	hours	14 days
Secondary	Rate and kind of cephalosporin using	3rd generation cephalosporin	14 days
Secondary	Rate and kind of Carbapenem using	Carbapenem	14 days
Secondary	Rate and kind of Vancomycin using	Vancomycin	14 days
Secondary	Rate of intraperitoneal fluid drainage	Positive	14 days
Secondary	Rate of CRRT	Positive	14 days