A Multicenter Double-blind Randomised Parallel Group Phase Three Superiority Clinical Trial on the Effectiveness of Dextran 40 Compared to Normal Saline in Preventing Dengue Shock in the Early Leakage Phase of Dengue Haemorrhagic Fever: Study Protocol

Background: Dengue haemorrhagic fever (DHF) remains a major cause of morbidity in tropical countries, with progression to shock contributing substantially to mortality. Early plasma leakage with organ hypoperfusion may represent a critical therapeutic window for intervention. This study evaluates whether dextran-40 is superior to normal saline in preventing dengue shock during the early leakage phase of DHF.
Methods: The Dextran in the Early Leakage Phase of Dengue Prevents Shock (DELPODS) study is a multicenter, double-blind, randomised, parallel-group phase III superiority trial conducted in Sri Lanka. Adults aged ≥18 years with confirmed dengue fever and evidence of early plasma leakage with organ hypoperfusion are randomised to receive either intravenous dextran-40 (5 mL/kg; maximum 250 mL) or 0.9% normal saline at an equivalent dose infused over 2 hours. Patients with advanced plasma leakage, established shock, pregnancy, acute kidney injury, advanced chronic kidney disease, severe heart failure, severe liver disease, or dextran hypersensitivity are excluded. The planned sample size is 218 participants.
Outcomes: The primary outcome is the incidence of shock within 48 hours of randomisation. Secondary outcomes include maintenance of haemodynamic stability, time to haemodynamic instability, need for additional fluid therapy, clinical outcomes at discharge, and safety outcomes including fluid overload, acute kidney injury, and hypersensitivity reactions.
Ethics and Registration: Ethical approval was obtained from the Ethics Review Committee of the Faculty of Medical & Allied Sciences, Rajarata University of Sri Lanka (22 June 2022). The trial is registered with the Sri Lanka Clinical Trial Registry (SLCTR/2022/003; U1111-1272-4389).