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Dengue hemorrhagic fever (DHF) and dengue shock syndrome (DSS) are among the leading causes of pediatric hospitalization in Asia.Mortality rates range from 1% at centres experienced in fluid resuscitation, to upto 44% in established shock.The mainstay of DSS treatment is prompt, vigorous fluid resuscitation with isotonic crystalloid solutions, followed by plasma or colloid solutions for profound or continuing shock. However, this administration is often associated with fluid overload and induces edema in these patients.
Hence, we planned a parallel, randomized controlled trial comparing the efficacy and safety of solution containing half molar sodium lactate (Totilac™) with standard treatment(isotonic crystalloid Ringer's Lactate) in pediatric Dengue Shock Syndrome patients, using plasma soluble Vascular Cell Adhesion Molecule(sVCAM-1) levels as an indicator.
Hypertonic solutions restore hemodynamic status rapidly with increased cardiac performance and improved tissue perfusion. This is obtained with much smaller volumes.We plan to assess the efficacy and safety of hypertonic sodium lactate in resuscitation of DHF/DSS patients.
Dengue affects an estimated 100 million people worldwide annually and is endemic in parts of Asia and the Americas, with increased incidence reported from many tropical countries recently.Dengue hemorrhagic fever (DHF) and dengue shock syndrome (DSS) are among the leading causes of pediatric hospitalization in Asia.Mortality rates range from 1% at centres experienced in fluid resuscitation, to upto 44% in established shock.
The mainstay of DSS treatment is prompt, vigorous fluid resuscitation with isotonic crystalloid solutions, followed by plasma or colloid solutions for profound or continuing shock. If appropriate volume resuscitation is started at an early stage, DSS is usually reversible. Patients who do not receive a proper treatment usually die within 12-24 hours after shock ensues. However, this administration is often associated with fluid overload and induces edema in these patients.
During hypovolemia in DHF/DSS, systemic hemodynamics and microcirculation are impaired, subsequently triggering a vicious cycle of progressive tissue damage that finally may lead to development of multiple organ failure. By adequately restoring intravascular volume, organ perfusion may be guaranteed, nutritive microcirculatory flow may be improved, and activation of a complex series of damaging cascades may be avoided.A solution that can rapidly restore systemic hemodynamic and improve microcirculation may be more beneficial in DHF/DSS patients.
Hypertonic solutions restore hemodynamic status rapidly with increased cardiac performance and improved tissue perfusion indicated by better urine output and tissue oxygenation. This is obtained with much smaller volumes.High lactate contained in hypertonic sodium lactate also functions as an alternate energy substrate.
However, the effects of hypertonic solution for resuscitating DHF/DSS patients have not yet investigated.Hence, we planned a parallel, randomized controlled trial comparing the efficacy and safety of solution containing half molar sodium lactate (Totilac™) with standard treatment(isotonic crystalloid Ringer's Lactate) in resuscitating pediatric Dengue Shock Syndrome patients, using plasma soluble Vascular Cell Adhesion Molecule(sVCAM-1) levels as an indicator of capillary endothelial leakage, which frequently occurs in DHF/DSS.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Dengue Shock Syndrome
Hypertonic sodium lactate, Ringer's lactate
Hasan Sadikin Hospital, Dept. of Pediatrics
Active, not recruiting
Innogene Kalbiotech Pte. Ltd
Published on BioPortfolio: 2014-08-27T03:19:45-0400
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A distinct and virulent form of DENGUE characterized by thrombocytopenia and hemoconcentration (grades I and II) and distinguished by a positive tourniquet test. When accompanied by circulatory failure and shock (grades III and IV), it is called dengue shock syndrome. (From Dorland, 28th ed)
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