Comparison of two fluid therapy regimen in children presenting with Dengue with warning signs and compensated shock( low blood flow from the heart to the organs) and look at the outcome
Not Applicable
- Conditions
- Health Condition 1: A90- Dengue fever [classical dengue]Health Condition 2: A91- Dengue hemorrhagic fever
- Registration Number
- CTRI/2020/01/022694
- Lead Sponsor
- ICMR New Delhi
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1) Children aged more than 28 days to completed 15 years
2) Confirmed Dengue Fever (NS1 positive by ELISA / Dengue IgM positive by ELISA
3) Children with Dengue fever with Warning Signs and /or Compensated Shock
Exclusion Criteria
1) Children with Severe Dengue (in Hypotensive shock, Severe bleeding causing shock, & Sever organ development as per WHO definition)
2) Refusal of consent
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1) Development of hypotensive shock (Hypotensive Shock: Systolic Blood pressure less than 5th centile for age & sex (age specific -PALS) <br/ ><br> <br/ ><br>2)Time to achieve desired haemodynamic response <br/ ><br> <br/ ><br> Hemodynamic stabilization will be defined as: <br/ ><br>Heart rate : Reduction of heart rate 20% from the baseline <br/ ><br>Systolic BP: Age specific ( 5th percentile for the age &sex ) or Mean blood pressure : age specific or Pulse pressure 30 mm Hg <br/ ><br>Urine output 0.75 ml/kg/hr <br/ ><br>Timepoint: Dengue with warning signs <br/ ><br>At 6 hours 15hours and 27 hours <br/ ><br> <br/ ><br>Dengue with Compensated Shock: <br/ ><br>At 4hours 10hours and at 18 hours
- Secondary Outcome Measures
Name Time Method 1) To compare the net fluid balance at 48hours and its respiratory effects <br/ ><br> <br/ ><br> Features of Fluid overload <br/ ><br> Respiratory rate (change 20% <br/ ><br> from baseline) <br/ ><br> Work of breathing : Usage of <br/ ><br> accessory muscles of respiration <br/ ><br> Increase in Oxygen requirement <br/ ><br> 2L/min from baseline <br/ ><br> Increased ascites (increased <br/ ><br> abdominal girth) <br/ ><br> <br/ ><br>2)Length of hospital stay <br/ ><br> <br/ ><br>3) 28 days mortality <br/ ><br>Timepoint: at 48 hours and 28 days mortality