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
Phase 3
Recruiting
- Conditions
- Dengue haemorrhagic fever
- Registration Number
- SLCTR/2022/003
- Lead Sponsor
- Rajarata University of Sri Lanka & University of Peradeniya
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- Not specified
Inclusion Criteria
1. All male and female patients
2. Aged 18 and above
3. Diagnosed with dengue fever
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method