NT-proBNP and Troponin I in Dengue Children

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: Recruiting
• Conditions: Children, Only; Dengue Shock Syndrome

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: Observational
• Enrollment (Estimated): 90

Contacts and Locations

• Study Contact: Name: Le P. Truyen, MD; Phone Number: +84 903640025; Email: dr.letruyen@ump.edu.vn
• Study Contact Backup: Name: Phung Nguyen, MD; Phone Number: 84 989043858; Email: nguyenphung@ump.edu.vn

Study Locations

• Vietnam
  • Ho Chi Minh City, Vietnam, 700000
    • Recruiting
    • University of Medicine and Pharmacy at Ho Chi Minh City
    • Contact: Truyen P. Le; Phone Number: +84 903640025; Email: dr.letruyen@ump.edu.vn
    • Principal Investigator: Truyen P. Le, MD

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Le Phuoc Truyen
• Investigators: Principal Investigator: Truyen P. Le, MD, University of Medicine and Pharmacy at Ho Chi Minh City

Study record dates

Study Major Dates

• Study Start (Actual): April 2, 2021
• Primary Completion (Estimated): December 31, 2023
• Study Completion (Estimated): December 31, 2023

Study Registration Dates

• First Submitted: April 3, 2021
• First Submitted That Met QC Criteria: April 7, 2021
• First Posted (Actual): April 8, 2021

Study Record Updates

• Last Update Posted (Actual): September 22, 2023
• Last Update Submitted That Met QC Criteria: September 20, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Troponin I; NT-proBNP; Dengue children; Cardiac enzyme
• Additional Relevant MeSH Terms: Pathologic Processes; RNA Virus Infections; Virus Diseases; Infections; Arbovirus Infections; Vector Borne Diseases; Flavivirus Infections; Flaviviridae Infections; Hemorrhagic Fevers, Viral; Shock; Dengue; Severe Dengue
• Other Study ID 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