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

Summary

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.

Conditions

• Trauma

Interventions

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.

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.

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

  lead OTHER

Principal Investigators

• Gurinder S Sangha, MD · London Health Sciences Centre, University of Western Ontario

• Douglas D Fraser, MD, PhD · London Health Sciences Centre, University of Western Ontario

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

1 Year

Max Age

17 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2013-05-31

Primary Completion

2014-08-31

Completion

2014-12-31

Countries

• Canada

Study Locations