Clinical trial NCT02866604: Comparison of an Isotonic Balanced Fluid, Sterofundin® , With 0.9% Saline in Traumatic Brain Injury(TBI)
Official title: Comparison of an Isotonic Balanced Fluid, Sterofundin® , With 0.9% Saline in Traumatic Brain Injury(TBI)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Brain Injuries
Keywords: Traumatic brain injury
isotonic balanced fluid
Lead sponsor: University of Malaya
Sponsor class: OTHER
First posted: 2016-08-15
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: 30 day mortality
timeFrame: 30 days
measure: Functional neurological outcomes at 6 months based on Extended Glasgow Outcome Scale (GOS-E)
timeFrame: 180 days
Secondary outcomes:
measure: Acid-base balance
timeFrame: 3 days
measure: Daily mean change in intracranial pressure (ICP)
timeFrame: 3 days
measure: Episodes of intracranial hypertension
timeFrame: 3 days
measure: Duration of mechanical ventilation
timeFrame: 3 days
measure: Length of ICU stay
timeFrame: 30 days
measure: electrolyte balance
timeFrame: 3 days
measure: ICU mortality
timeFrame: 30 days
Other outcomes:
Locations:
city: Petaling Jaya
country: Malaysia
facility: University of Malaya Medical Centre
state: Wilayah Persekutuan Kuala Lumpur
Study officials:
References: