A MULTI CENTER DOUBLE-BLIND RANDOMIZED PARALLEL-GROUP PHASE III CLINICAL TRIAL ON EFFECTIVENESS OF DEXTRAN 40 COMPARED TO NORMAL SALINE IN PREVENTING DENGUE SHOCK IN EARLY LEAKAGE PHASE OF PATIENTS WITH DENGUE HEMORRHAGIC FEVER

Dextran in Early Leakage Phase of Dengue Prevents Shock

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

SLCTR

Registry ID

SLCTR/2022/003

Enrollment

Unknown

Registered

2022-02-07

Start date

2022-02-09

Completion date

Unknown

Last updated

2026-08-03

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

Conditions

Dengue haemorrhagic fever

Interventions

Study setting Professorial medical units of Teaching Hospitals Anuradhapura and Peradeniya. Randomization method Permuted block randomization will be done by a person who is not part of the study. Va

Eligibility

Inclusion criteria

Inclusion criteria: 1. All male and female patients 2. Aged 18 and above 3. Diagnosed with dengue fever

Exclusion criteria

Exclusion criteria: 1. Patients who have evidence of advanced plasma leakage or established on admission 2. Known hypersensitivity to dextran 3. Pregnant mothers & children 4. Patients with acute kidney injury 5. Advanced CKD (Stage V) 6. Severe heart failure (NYHA class III & IV) 7. Severe liver disease (Child’s C) 8. Diabetics with autonomic dysfunction 9. Patients on beta blockers, calcium channel blockers and sinus node blockers

Design outcomes

Primary

Measure	Time frame
Reduction of proportion of compensated or uncompensated shock by 15% in the dextran group compared to control group Compensated shock: Tachycardia with narrow pulse pressure ( 15 beats per min from the supine position to erect position (within 3-5 min) at the time of examination. Baseline for postural tachycardia is resting pulse rate at lying position when the patient is euvolemic and afebrile [ One hour after drug administration] Proportion of patients with improved urine output i.e more than 0.5ml/Kg/hour [The first measurement is one hour after study drug administration and hourly thereafter for 48 hrs or end of leaking phase.]	—

Measure

Time frame

Reduction of proportion of compensated or uncompensated shock by 15% in the dextran group compared to control group Compensated shock: Tachycardia with narrow pulse pressure ( 15 beats per min from the supine position to erect position (within 3-5 min) at the time of examination. Baseline for postural tachycardia is resting pulse rate at lying position when the patient is euvolemic and afebrile [ One hour after drug administration] Proportion of patients with improved urine output i.e more than 0.5ml/Kg/hour [The first measurement is one hour after study drug administration and hourly thereafter for 48 hrs or end of leaking phase.]

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Secondary

Measure	Time frame
Duration of maintenance of normal urine output (> 0.5ml/kg) after study drug administration [One hourly after study drug administration for 48 hours] Percentage change of inferior vena cava (IVC) diameter post drug administration [ One hour after drug administration ] Amount of total fluid needed to maintain haemodynamic stability over the critical phase [Calculated at the end of the leaking phase] Number of rescue fluid boluses needed over 1st, 2nd, 3rd and 4th twelve-hour periods, post study drug administration. [ 1st, 2nd, 3rd and 4th twelve-hour periods, post study drug administration. ]	—

Measure

Time frame

Duration of maintenance of normal urine output (> 0.5ml/kg) after study drug administration [One hourly after study drug administration for 48 hours] Percentage change of inferior vena cava (IVC) diameter post drug administration [ One hour after drug administration ] Amount of total fluid needed to maintain haemodynamic stability over the critical phase [Calculated at the end of the leaking phase] Number of rescue fluid boluses needed over 1st, 2nd, 3rd and 4th twelve-hour periods, post study drug administration. [ 1st, 2nd, 3rd and 4th twelve-hour periods, post study drug administration. ]

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Countries

Sri Lanka

Contacts

Public ContactDr. Chamara Sarathchandra

Senior lecturer in Medicine

nilupulchamara@gmail.com0252227706

Outcome results

None listed

Source: SLCTR (via WHO ICTRP) · Data processed: Aug 9, 2026