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

Brain Injuries Clinical Trial

— FLUID  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02866604
• Other study ID #: 201510-1766
• Status: Not yet recruiting
• Phase: N/A
• First received: May 23, 2016
• Last updated: October 25, 2016
• Start date: October 2016
• Est. completion date: February 2019

Study information

• Verified date: October 2016
• Source: University of Malaya
• Contact: Sia S Fu, MSurg, PhD
• Phone: +603-79492441
• Email: sfsia02[@]um.edu.my
• Is FDA regulated: No
• Health authority: Malaysia: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 160
• Est. completion date: February 2019
• Est. primary completion date: August 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Brain Injuries
• Wounds and Injuries

Intervention

Procedure:
• Sterofundin

• 0.9% saline

Locations

Country	Name	City	State
Malaysia	University of Malaya Medical Centre	Petaling Jaya	Wilayah Persekutuan Kuala Lumpur

Sponsors (1)

Lead Sponsor	Collaborator
University of Malaya

Country where clinical trial is conducted

Malaysia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	30 day mortality		30 days	No
Primary	Functional neurological outcomes at 6 months based on Extended Glasgow Outcome Scale (GOS-E)		180 days	No
Secondary	Acid-base balance	through out intervention period	3 days	No
Secondary	Daily mean change in intracranial pressure (ICP)	through out intervention period	3 days	No
Secondary	Episodes of intracranial hypertension	through out intervention period	3 days	No
Secondary	Duration of mechanical ventilation	through out intervention period	3 days	No
Secondary	Length of ICU stay	through out intervention period	30 days	No
Secondary	electrolyte balance		3 days	No
Secondary	ICU mortality		30 days	No