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Study on intravenous fluids in dengue shock

Phase 3
Conditions
Health Condition 1: A91- Dengue hemorrhagic fever
Registration Number
CTRI/2023/11/060213
Lead Sponsor
Indian Council of Medical Research
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Yet Recruiting
Sex
Not specified
Target Recruitment
0
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 ( <100000 cells per mm3) with increased vascular permeability (viz. > 20% increase in haematocrit, >20% decrease in haematocrit after fluid therapy, pleural effusion, ascites, hypoproteinemia).

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

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
= 5mmol/L increase in serum chloride level within 48 hours (h) post-randomization.Timepoint: Baseline, 48 hours
Secondary Outcome Measures
NameTimeMethod
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
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