Status:
UNKNOWN
Effect of Hypertonic Sodium Lactate on sVCAM-1 Level as Surrogate Marker of Endothelial Capillary Leakage in Pediatric Dengue Shock Syndrome Patients (DSS)
Lead Sponsor:
Innogene Kalbiotech Pte. Ltd
Conditions:
Dengue Shock Syndrome
Eligibility:
All Genders
2-14 years
Phase:
PHASE3
Brief Summary
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 resuscita...
Detailed Description
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 hemor...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00966628
Start Date
May 1 2008
End Date
December 1 2009
Last Update
August 28 2009
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Hasan Sadikin Hospital, Dept. of Pediatrics
Bandung, West Java, Indonesia, 40161