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Trial Of Normal Saline Versus Ringer's Lactate In Paediatric Trauma Patients

This study is not yet open for participant recruitment.
Verified September 2012 by Lawson Health Research Institute
Sponsor:
Information provided by (Responsible Party):
Gurinder Sangha, Lawson Health Research Institute
ClinicalTrials.gov Identifier:
NCT01692769
First received: September 19, 2012
Last updated: September 25, 2012
Last verified: September 2012
History of Changes
  Purpose

Background: Trauma is a major cause of death in children and teenagers. When young patients have suffered major traumatic injuries, they require intravenous (iv) fluids to keep their blood vessels full and ensure blood flow to vital organs. Current fluid guidelines by International Trauma Committees recommend either Normal Saline (NS) or Ringer's Lactate (RL) as the fluid of choice for these patients. Although these solutions share some similarities in their composition, there are also some significant differences in sodium, chloride and lactate concentrations. Despite these differences in fluid composition, there has never been a study comparing these two fluids in paediatric trauma patients to determine which is optimal. In this study, the investigators aim to determine the optimal fluid choice for trauma resuscitation of young patients.

Hypothesis: The investigators hypothesize that severely injured paediatric trauma patients resuscitated with NS will have optimal blood sodium levels compared to patients resuscitated with RL.

Methods: The investigators will study 50 paediatric trauma patients that will be randomized so that half will randomly receive NS and half will receive RL as their only iv fluid for 24 hours. After 24 hours, the investigators will compare in blood the sodium level, the amount of acid, and the concentrations of inflammation molecules in relation to those whom received NS versus RL.

Expected Results and Significance: Maintaining optimal levels of these biochemical markers is imperative in reducing morbidity and mortality in severely injured paediatric patients. If significant differences are present, the investigators will be able to determine which fluid is preferred and expect these data to complement current trauma resuscitation guidelines.


Condition Intervention Phase
Trauma
 Drug: Normal Saline
Drug: Ringer's Lactate
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial of Intravenous Fluid In Severely Injured Paediatric Trauma Patients: Comparison of Normal Saline Versus Ringer's Lactate

Resource links provided by NLM:

MedlinePlus related topics: Injuries Wounds
U.S. FDA Resources

Further study details as provided by Lawson Health Research Institute:

Primary Outcome Measures:
  • The difference in serum sodium change over 24 hours between patients receiving NS versus RL [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The difference in serum pH [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
  • The difference serum chloride [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
  • The differences in serum bicarbonate [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
  • The differences in serum inflammatory biomarker change: Erythrocyte Sedimentation Rate (ESR) [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
  • The differences in serum inflammatory biomarker change: C-Reactive Protein [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
  • The differences in serum inflammatory biomarker change: InterLeukin-6 [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
  • The differences in serum inflammatory biomarker change InterLeukin-8 [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
  • The differences in serum inflammatory biomarker change: G-CSF [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
  • The differences in serum inflammatory biomarker change: MCP-1 [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: October 2012
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Normal Saline
Patients will receive intravenous normal saline for all resuscitation and maintenance fluid for a period of 24 hours commencing on presentation to hospital.
 Drug: Normal Saline
Patients randomized to Normal Saline arm, will receive intravenous normal saline for all resuscitation and maintenance fluid for a period of 24 hours commencing on presentation to hospital.
Other Name: 0.9% Normal Saline
Active Comparator: Ringer's Lactate
Patients will receive intravenous Ringer's Lactate for all resuscitation and maintenance fluid for a period of 24 hours commencing on presentation to hospital.
 Drug: Ringer's Lactate
Patients randomized to Ringer's Lactate arm, will receive intravenous Ringer's Lactate for all resuscitation and maintenance fluid for a period of 24 hours commencing on presentation to hospital.
Other Name: Lactated Ringers

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   1 Year to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Pediatric trauma patients with Injury Severity Score greater than 12
  • Age 1-17 years
  • Trauma within 8 hours

Exclusion Criteria:

  • Injury Severity Score less than 12
  • Pre-existing renal disease
  • On medication that affects serum sodium (i.e diuretic therapy)
  • Blood transfusion within first 24 hours
  • Operation within first 24 hours
  • Oral intake of fluid or solids in first 24 hours
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01692769

Contacts
Contact: Gurinder S Sangha, MD Gurinder.Sangha@lhsc.on.ca

Locations
Canada, Ontario
Children's Hospital, London Health Sciences Centre Not yet recruiting
London, Ontario, Canada, N6A5W9
Contact: Gurinder S Sangha, MD         Gurinder.Sangha@lhsc.on.ca    
Principal Investigator: Gurinder S Sangha, MD            
Principal Investigator: Douglas D Fraser, MD, PhD            
Sponsors and Collaborators
Lawson Health Research Institute
Investigators
Principal Investigator: Gurinder S Sangha, MD London Health Sciences Centre, University of Western Ontario
Principal Investigator: Douglas D Fraser, MD, PhD London Health Sciences Centre, University of Western Ontario
  More Information

No publications provided

Responsible Party: Gurinder Sangha, Principal Investigator, Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT01692769     History of Changes
Other Study ID Numbers: 102632
Study First Received: September 19, 2012
Last Updated: September 25, 2012
Health Authority: Canada: Canadian Institutes of Health Research
Canada: Ethics Review Committee
Canada: Health Canada
Canada: Ministry of Health & Long Term Care, Ontario
Canada: Public Health Agency of Canada

Keywords provided by Lawson Health Research Institute:
Trauma
Pediatric
Intravenous Fluid
Normal Saline
Ringer's Lactate

Additional relevant MeSH terms:
Wounds and Injuries

ClinicalTrials.gov processed this record on May 23, 2013