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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

Volume Replacement therapy in children with Dengue: Single centre, Open Labeled, Randomized Control Study to compare the hemodynamic response of two fluid replacement therapy regimen in children presenting with warning signs and compensated shock

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/01/022694
Enrollment
222
Registered
2020-01-10
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: A90- Dengue fever [classical dengue] Health Condition 2: A91- Dengue hemorrhagic fever

Interventions

Intervention1: NEW "CMC-ICMR Fluid Therapy": For children with Dengue with warming signs: 1) 30ml/kg of Isotonic crystalloids over 6 hours, REASSESS every 3 hours 2) 30ml/kg over 9 hours ,Reassess 3)

Sponsors

ICMR New Delhi
Lead Sponsor
CMCVellore
Collaborator

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
1) Development of hypotensive shock (Hypotensive Shock: Systolic Blood pressure less than 5th centile for age & sex (age specific -PALS) 2)Time to achieve desired haemodynamic response Hemodynamic stabilization will be defined as: Heart rate : Reduction of heart rate 20% from the baseline Systolic BP: Age specific ( 5th percentile for the age &sex ) or Mean blood pressure : age specific or Pulse pressure 30 mm Hg Urine output 0.75 ml/kg/hr Timepoint: Dengue with warning signs At 6 hours 15hours and 27 hours Dengue with Compensated Shock: At 4hours 10hours and at 18 hours—

Secondary

MeasureTime frame
1) To compare the net fluid balance at 48hours and its respiratory effects Features of Fluid overload Respiratory rate (change 20% from baseline) Work of breathing : Usage of accessory muscles of respiration Increase in Oxygen requirement 2L/min from baseline Increased ascites (increased abdominal girth) 2)Length of hospital stay 3) 28 days mortality Timepoint: at 48 hours and 28 days mortality—

Countries

India

Contacts

Public ContactEbor Jacob Gnananayagam J

Christian Medical College,Vellore

eborjacob@gmail.com8870333409

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026