Dengue Shock Syndrome Clinical Trial
Official title:
The Effect of Hypertonic Sodium Lactate on sVCAM-1 Level as a Surrogate Marker of Endothelial Capillary Leakage in Pediatric Dengue Shock Syndrome Patients
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 (Totilacâ„¢) 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 (Totilacâ„¢) 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.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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