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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Brain Injuries

Intervention / Treatment
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* Procedure: Sterofundin
* Procedure: 0.9% saline


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Strerofundin<br>Days of intervention: 3 days | Procedure: Sterofundin<br> <br> |
| Active Comparator: 0.9% saline<br>Days of intervention: 3 days | Procedure: 0.9% saline<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Traumatic brain injury, isotonic balanced fluid