NT-proBNP and Troponin I in Dengue Children

Recruiting

• Conditions: Dengue Shock Syndrome; Children, Only

• Registration Number: NCT04837430
• Lead Sponsor: Le Phuoc Truyen

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.

Study Timeline

• Study Start: 2021-04-02
• Study First Submitted: 2021-04-03
• Study First Submitted QC: 2021-04-07
• Study First Posted: 2021-04-08
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-20
• Last Update Posted: 2023-09-22
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 90

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Concentration of NT-proBNP	10 days	Concentration of NT-proBNP in Children with Dengue hemorrhagic shock and severe shock
Concentration of Troponin I	10 days	Concentration of Troponin I in Children with Dengue hemorrhagic shock and severe shock

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University of medicine and pharmacy at Ho Chi Minh city; 🇻🇳 Ho Chi Minh City, Vietnam