Comparison of an Isotonic Balanced Fluid, Sterofundin® , With 0.9% Saline in Traumatic Brain Injury(TBI)
NCT ID: NCT02866604
Last Updated: 2016-10-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
160 participants
INTERVENTIONAL
2016-10-31
2019-02-28
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Strerofundin
Days of intervention: 3 days
Sterofundin
0.9% saline
Days of intervention: 3 days
0.9% saline
Interventions
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Sterofundin
0.9% saline
Eligibility Criteria
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Inclusion Criteria
* 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
* Polytrauma
* Cardiac arrest at presentation
* GCS of three with bilateral fixed dilated pupils,
* Evidence of severe cardiac, respiratory, renal or liver dysfunction
18 Years
ALL
No
Sponsors
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University of Malaya
OTHER
Responsible Party
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Locations
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University of Malaya Medical Centre
Petaling Jaya, Kuala Lumpur, Malaysia
Countries
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Central Contacts
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Facility Contacts
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Sia S Fung, MSurg, PhD
Role: primary
Other Identifiers
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201510-1766
Identifier Type: -
Identifier Source: org_study_id