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

NCT00966628 | Unknown Phase 3

• 1 other identifier: 006/IGK-KAL/08
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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 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

Keywords

pediatric; dengue; hypertonic sodium lactate; fluid resuscitation; Ringer's lactate

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• 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.

Study Arms (2)

Ringer's lactate

ACTIVE COMPARATOR

Drug: Ringer's lactate

Hypertonic sodium lactate

EXPERIMENTAL

Drug: Hypertonic sodium lactate

Interventions

Hypertonic sodium lactate DRUG

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.

Also known as: Totilac™

Hypertonic sodium lactate

Ringer's lactate DRUG

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.

Ringer's lactate

Eligibility Criteria

• Age: 2 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Innogene Kalbiotech Pte. Ltd: lead

Study Sites (1)

Hasan Sadikin Hospital, Dept. of Pediatrics

Bandung, West Java, 40161, Indonesia

Location

Related Publications (21)

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  BACKGROUND

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  BACKGROUND

• Somasetia DH, Setiati TE, Sjahrodji AM, Idjradinata PS, Setiabudi D, Roth H, Ichai C, Fontaine E, Leverve XM. Early resuscitation of dengue shock syndrome in children with hyperosmolar sodium-lactate: a randomized single-blind clinical trial of efficacy and safety. Crit Care. 2014 Sep 5;18(5):466. doi: 10.1186/s13054-014-0466-4.

  PMID: 25189175 DERIVED

MeSH Terms

Conditions

Severe Dengue; Dengue

Interventions

Ringer's Lactate

Condition Hierarchy (Ancestors)

Mosquito-Borne Diseases; Vector Borne Diseases; Infections; Arbovirus Infections; Virus Diseases; Flavivirus Infections; Flaviviridae Infections; RNA Virus Infections; Hemorrhagic Fevers, Viral

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Xavier Leverve, MD, PhD

  INSERM-E0221-Bioenergetique Fondamentale et Appliquée Université Joseph Fourier, France

  STUDY CHAIR

• Dadang H Somasetia, SpA(K), MKes

  Hasan Sadikin Hospital, Dept. of Pediatrics, Bandung, Indonesia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: August 26, 2009
• First Posted: August 27, 2009
• Study Start: May 1, 2008
• Primary Completion: April 1, 2009
• Study Completion: December 1, 2009
• Last Updated: August 28, 2009

Record last verified: 2009-08

Locations

ID (1)