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A study to compare need based fluids to guidelines-based fluids in patients of dengue with warning signs

Need-based vs guidelines-based fluid administration in dengue patients with warning signs: Open-label randomized study.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2019/09/021026
Enrollment
80
Registered
2019-09-02
Start date
Unknown
Completion date
Unknown
Last updated
2023-07-25

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

Conditions

Health Condition 1: B348- Other viral infections of unspecified site

Interventions

Intervention1: Need based fluids (0.9% saline/ Ringerâ??s lactate): as per SV and IVC parameters in 2D echocardiography Control Intervention1: Guidelines based Isotonic solution such as 0.9% saline/ R

Sponsors

Indian Council of Medical Research
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Confirmed dengue fever (NS 1 positive by ELISA/ Dengue IgM positive by ELISA) with warning signs such as Abdominal pain or tenderness Persistent vomiting Clinical fluid accumulation Mucosal bleed Lethargy, restlessness Laboratory: increase in HCT concurrent with rapid decrease in platelet counts

Exclusion criteria

Exclusion criteria: 1) Pregnancy/ lactation 2) Refusal to give consent

Design outcomes

Primary

MeasureTime frame
To study hemodynamic outcomes (heart rate, blood pressure and urine output) in dengue patients with warning signs receiving guidelines-based and need-based fluid therapyTimepoint: every 4 hourly assessment—

Secondary

MeasureTime frame
1. Development of shock 2. Requirement of vasopressors 3. Volume of fluid infused till recovery 4. Fluid overload 5. Length of hospital stay 6. Clinically significant bleeding 7. MortalityTimepoint: baseline and every 4 hours—

Countries

India

Contacts

Public ContactDr Manish Soneja

AIIMS, New Delhi

manishsoneja@gmail.com9013074717

Outcome results

None listed

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