Comparison of an Isotonic Balanced Fluid, Sterofundin® , With 0.9% Saline in Traumatic Brain Injury(TBI) (FLUID)

The main objective of this study is to compare the clinical outcomes of TBI patients receiving only Sterofundin or 0.9% saline as main fluid therapy.

Study Overview

• Status: Unknown
• Conditions: Brain Injuries
• Intervention / Treatment: Procedure: Sterofundin; Procedure: 0.9% saline

Detailed Description

Study Design: Prospective single centre double-blind randomized controlled trial

Study endpoints/outcomes

Primary outcomes:

• 30 day mortality
• Functional neurological outcomes at 6 months based on Extended Glasgow Outcome Scale (GOS-E)

Secondary outcomes:

• Acid-base and electrolyte balance
• Daily mean change in intracranial pressure (ICP)
• Episodes of intracranial hypertension
• Duration of mechanical ventilation
• Length of ICU stay and ICU mortality

Study Duration: 2 years Site: UMMC. Departments involved: Emergency Medicine, Surgery, Anaesthesiology and Pharmacy

Methodology. Investigators will assess patients admitted to the Emergency Department, UMMC, for eligibility.

Randomisation:

Investigators will randomize patients in a 1:1 ratio to either 0.9% saline intravenous fluid group or Sterofundin® intravenous fluid group. An independent statistician not involved with the research will perform a block of eight randomisation using computerised number generator list.

Conduct of study The Department of Pharmacy will identically seal all 0.9% saline and Sterofundin® intravenous fluid bottles and label them, according to their type, as either A or B. The patients, investigators and medical and nursing staff will not be aware of the designation of the letters A and B to the fluids.

Investigators will administer the study fluid will immediately after patient randomisation and this will last for 72 hours.

Other general care of the traumatic brain injury patients from both study arms will continue as per Neurosurgical Unit protocol and Brain Trauma Foundation guidelines.

Data handling

Investigators will collect all data relevant to both primary and secondary outcomes (see also attached proforma):

Statistical analysis Investigators will conduct students t test, Chi squared and the Mann-Whitney U test as appropriate. Investigators will adjust results with univariable and multivariable logistic regression and report their odds ratio. Investigators will present survival analysis using Kaplan Meier curves and compare them using log rank test.

• Study Type: Interventional
• Enrollment (Anticipated): 160
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sia S Fu, MSurg, PhD; Phone Number: +603-79492441; Email: sfsia02@um.edu.my

Study Locations

• Malaysia
  • Wilayah Persekutuan Kuala Lumpur
    • Petaling Jaya, Wilayah Persekutuan Kuala Lumpur, Malaysia, 50603
      • University of Malaya Medical Centre
      • Contact: Sia S Fung, MSurg, PhD; Phone Number: +603-79492441; Email: sfsia02@um.edu.my

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients age between 18 and 65 years of age
• Non-penetrating moderate (GCS 9-12) or severe (GCS 3-8) traumatic brain injury
• Within 12 hours since the recorded time of injury

Exclusion Criteria:

• Pregnancy
• Polytrauma
• Cardiac arrest at presentation
• GCS of three with bilateral fixed dilated pupils,
• Evidence of severe cardiac, respiratory, renal or liver dysfunction

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Strerofundin; Days of intervention: 3 days	Procedure: Sterofundin
Active Comparator: 0.9% saline; Days of intervention: 3 days	Procedure: 0.9% saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
30 day mortality	30 days
Functional neurological outcomes at 6 months based on Extended Glasgow Outcome Scale (GOS-E)	180 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acid-base balance	through out intervention period	3 days
Daily mean change in intracranial pressure (ICP)	through out intervention period	3 days
Episodes of intracranial hypertension	through out intervention period	3 days
Duration of mechanical ventilation	through out intervention period	3 days
Length of ICU stay	through out intervention period	30 days
electrolyte balance		3 days
ICU mortality		30 days

Collaborators and Investigators

• Sponsor: University of Malaya

Study record dates

Study Major Dates

• Study Start: October 1, 2016
• Primary Completion (Anticipated): August 1, 2018
• Study Completion (Anticipated): February 1, 2019

Study Registration Dates

• First Submitted: May 23, 2016
• First Submitted That Met QC Criteria: August 10, 2016
• First Posted (Estimate): August 15, 2016

Study Record Updates

• Last Update Posted (Estimate): October 26, 2016
• Last Update Submitted That Met QC Criteria: October 25, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Keywords: Traumatic brain injury; isotonic balanced fluid
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries; Wounds and Injuries; Brain Injuries, Traumatic
• Other Study ID Numbers: 201510-1766

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No