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

NCT01692769 | Completed Phase 4

• 1 other identifier: 102632
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Trauma; Pediatric; Intravenous Fluid; Normal Saline; Ringer's Lactate

Outcome Measures

Primary Outcomes (1)

• The difference in serum sodium change over 24 hours between patients receiving NS versus RL

  24 hours

Secondary Outcomes (9)

• The difference in serum pH

  24 hours

• The difference serum chloride

  24 hours

• The differences in serum bicarbonate

  24 hours

• The differences in serum inflammatory biomarker change: Erythrocyte Sedimentation Rate (ESR)

  24 hours

• The differences in serum inflammatory biomarker change: C-Reactive Protein

  24 hours

Study Arms (2)

Normal Saline

ACTIVE COMPARATOR

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

Ringer's Lactate

ACTIVE COMPARATOR

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

Interventions

Normal Saline DRUG

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.

Also known as: 0.9% Normal Saline

Normal Saline

Ringer's Lactate DRUG

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.

Also known as: Lactated Ringers

Ringer's Lactate

Eligibility Criteria

• Age: 1 Year - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Children's Hospital, London Health Sciences Centre

London, Ontario, N6A5W9, Canada

Location

MeSH Terms

Conditions

Wounds and Injuries

Interventions

Saline Solution; Ringer's Lactate

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2012
• First Posted: September 25, 2012
• Study Start: May 1, 2013
• Primary Completion: August 1, 2014
• Study Completion: December 1, 2014
• Last Updated: November 6, 2018

Record last verified: 2018-11

Locations

CA (1)