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Effect of Hypertonic Sodium Lactate on sVCAM-1 Level as Surrogate Marker of Endothelial Capillary Leakage in Pediatric Dengue Shock Syndrome Patients (DSS)

NCT00966628 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2009-08-28

No results posted yet for this study

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 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.

Conditions

  • Dengue Shock Syndrome

Interventions

DRUG

Hypertonic sodium lactate

Hypertonic sodium lactate 5 ml/kg BW administered within 15 minutes to restore hemodynamic status. If shock state did not recover with first infusion, study solution infused again at same dose. After recovery from shock state, patients receive maintenance dose at 1 mL/kgBW/hour for 12 hours. After 12 hr. infusion with study fluid, patients receive RL infusion as per standard protocol of DSS management at site.In case of repeated shock within 12 hours, study drugs can be infused again. If patient still not recovered from shock state, the patients will be given HES (Hydroxy-Ethyl Starch) infusion at dose of 20 mL/kgBW/15-30 min with maximum dose of 50 mL/kgBW/24 hours.

DRUG

Ringer's lactate

Ringer lactate infused at dose 20 mL/kgBW within 15 minutes to restore hemodynamic status. If shock state did not recover with first infusion, study fluid infused again at same dose. After recovery from shock, patient received maintenance dose of RL. In case of repeated shock, patients received HES (Hydroxy-Ethyl Starch) infusion at dose of 20 mL/kgBW/15-30 min with maximum dose of 50 mL/kgBW/24 hours.

Sponsors & Collaborators

  • Innogene Kalbiotech Pte. Ltd

    lead INDUSTRY

Principal Investigators

  • Xavier Leverve, MD, PhD · INSERM-E0221-Bioenergetique Fondamentale et Appliquée Université Joseph Fourier, France

  • Dadang H Somasetia, SpA(K), MKes · Hasan Sadikin Hospital, Dept. of Pediatrics, Bandung, Indonesia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
14 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-05-31
Primary Completion
2009-04-30
Completion
2009-12-31

Countries

  • Indonesia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00966628 on ClinicalTrials.gov