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Study on intravenous fluids in dengue shock

Standard therapy versus PLasmalyte In children with Dengue Shock Syndrome (SPLID TRIAL): an open labelled randomised control trial - nil

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/11/060213
Enrollment
135
Registered
2023-11-23
Start date
Unknown
Completion date
Unknown
Last updated
2025-10-13

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

Conditions

Health Condition 1: A91- Dengue hemorrhagic fever

Interventions

Intervention1: Plasmalyte: Children in PL/NS/RL group will be started with 10-20ml/kg bolus of study fluid(4,6) in initial 30 mins, if the hematocrit falls, pulse rate and blood pressure stable and ur

Sponsors

Indian Council of Medical Research
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Children suffering from dengue shock syndrome (DSS) will be enrolled. DSS will be defined as DHF as well as hypotension, tachycardia, narrow pulse pressure (less than/equal to 20 mmHg) and signs of poor perfusion (e.g cold extremities, delayed capillary filling time, feeble pulses). Dengue Haemorrhagic Fever (DHF) will be defined as a child fulfilling clinical criteria of dengue fever with bleeding tendencies viz., petechiae, ecchymoses or purpura, positive tourniquet test and/or skin, mucosal or gastrointestinal bleed with thrombocytopenia ( 20% increase in haematocrit, >20% decrease in haematocrit after fluid therapy, pleural effusion, ascites, hypoproteinemia).

Exclusion criteria

Exclusion criteria: 1) Children already received fluids from outside before enrolment in last 6 h 2) Children with cardiogenic shock 3) Known patient with chronic kidney disease as per KDIGO. 4) Severe malnutrition defined as per WHO. 5) Children whose parents deny consent

Design outcomes

Primary

MeasureTime frame
= 5mmol/L increase in serum chloride level within 48 hours (h) post-randomization.Timepoint: Baseline, 48 hours

Secondary

MeasureTime frame
hospital stay duration, need for colloid bolus, incidence of hyponatremia (serum sodium less than 135 mmol/L in the first 48 h of fluid management), new-onset AKI, standard base excess, serum lactate levels, renal replacement therapy, organ dysfunction (25)and serum magnesium levels.Timepoint: first 48 hours, during hospital stay

Countries

India

Contacts

Public ContactVidushi Mahajan

Government Medical College and Hospital Chandigarh

vidushimahajan2003@yahoo.co.in9646121531

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Apr 3, 2026