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 (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.
Status | Active, not recruiting |
Enrollment | 50 |
Est. completion date | December 2009 |
Est. primary completion date | April 2009 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 2 Years to 14 Years |
Eligibility |
Inclusion Criteria: - Pediatric patients with dengue shock syndrome - Ages 2-14 years - Resuscitation treatment naïve for DSS - Fulfill WHO criteria for dengue shock syndrome - Signed informed consent Exclusion Criteria: - Patients with history of nephritic syndrome or severe renal impairment (creatinine > 2 mg/dL ), severe liver impairment (SGOT & SGPT > 2x normal), chronic diarrhea, severe malnutrition, diabetes mellitus, and history of hematological disorder based on anamnesis, physical examination, and/or lab exam. - Patients who are confirmed to have suffered viral or bacterial infection based on anamnesis, physical examination, and lab exam |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Indonesia | Hasan Sadikin Hospital, Dept. of Pediatrics | Bandung | West Java |
Lead Sponsor | Collaborator |
---|---|
Innogene Kalbiotech Pte. Ltd |
Indonesia,
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* Note: There are 20 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To assess the effect of solution containing half molar sodium lactate (Totilac™) infusion on the plasma sVCAM-1 level | sVCAM-1 levels measured before resuscitation, after 6 hours, 12 hours, 24 hours & 48 hours post resuscitation | No | |
Secondary | To assess the effect of solution containing half molar sodium lactate (Totilac™) infusion on other efficacy and safety parameters | Hemodynamic parameters monitored hourly. Lab parameters measured 1 hour post resuscitation and every 3 hours thereafter, based on disease severity, upto 12 hours post resuscitation. Serology exams also done at day 5 from fever onset or thereafter. | Yes |
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