An observational study in Dengue Shock Syndrome and Children, Only, sponsored by Le Phuoc Truyen. Recruiting at 1 site in Vietnam. Open to participants aged 1 Month to 18 Years. Per ClinicalTrials.gov, last updated 2023-09-22.
Sponsored by Le Phuoc Truyen · Observational
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.
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.
65 studies on the registry are indexed under Severe Dengue; 5 are open to participants now.
This study's planned enrollment of 90 is below the median of 667 across 13 observational studies indexed under Severe Dengue.
Browse Severe Dengue studies →This is the only study on the registry with Le Phuoc Truyen as lead sponsor.
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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 (+)
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Concentration of NT-proBNP
Concentration of NT-proBNP in Children with Dengue hemorrhagic shock and severe shock
Time frame: 10 days
Concentration of Troponin I
Concentration of Troponin I in Children with Dengue hemorrhagic shock and severe shock
Time frame: 10 days
Cut-off value of NT-proBNP for fluid overload
Cut-off value of NT-proBNP for pulmonary edema
Time frame: 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
Time frame: 14 days
Correlation between concentration of Troponin I
Correlation between concentration of Troponin I total fluid admission, respiratory support, using inotrope and vasopressor using
Time frame: 14 days
Rate of clinical manifestations
Rate of clinical manifestations: fever, abdominal pain, petechia, hematomegaly
Time frame: 14 days
Rate of abnormal laboratory exam
electrolyte, arterial blood gas, lactate
Time frame: 14 days
Rate of abnormal liver, kidney, hematology laboratory exam
AST, ALT, ure, creatinin, PLT, PT, aPTT, Fibrinogen
Time frame: 14 days
Rate of NS1 Dengue
Positive
Time frame: 10 days
Rate of MAC ELISA IgM Dengue
Positive
Time frame: 14 days
Rate of complications
Pulmonary edema
Time frame: 14 days
Rate of respiratory support
Cannula, NCPAP, Intubation
Time frame: 14 days
Rate of intubation
Positive
Time frame: 14 days
Rate of mode of ventilation
PC, IP, PEEP, FiO2, VT
Time frame: 14 days
Total fluid administration
ml/kg/d
Time frame: 14 days
Time for IV fluid administration
hours
Time frame: 14 days
Rate and kind of cephalosporin using
3rd generation cephalosporin
Time frame: 14 days
Rate and kind of Carbapenem using
Carbapenem
Time frame: 14 days
Rate and kind of Vancomycin using
Vancomycin
Time frame: 14 days
Rate of intraperitoneal fluid drainage
Positive
Time frame: 14 days
Rate of CRRT
Positive
Time frame: 14 days
Plan to share: No
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