Comparison of an Isotonic Balanced Fluid, Sterofundin® , With 0.9% Saline in Traumatic Brain Injury(TBI) (FLUID)
|ClinicalTrials.gov Identifier: NCT02866604|
Recruitment Status : Unknown
Verified October 2016 by University of Malaya.
Recruitment status was: Not yet recruiting
First Posted : August 15, 2016
Last Update Posted : October 26, 2016
|Condition or disease||Intervention/treatment||Phase|
|Brain Injuries||Procedure: Sterofundin Procedure: 0.9% saline||Not Applicable|
Study Design: Prospective single centre double-blind randomized controlled trial
- 30 day mortality
- Functional neurological outcomes at 6 months based on Extended Glasgow Outcome Scale (GOS-E)
- 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.
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.
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 (Clinical Trial)|
|Estimated Enrollment :||160 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Comparison of an Isotonic Balanced Fluid, Sterofundin® , With 0.9% Saline in Traumatic Brain Injury(TBI)|
|Study Start Date :||October 2016|
|Estimated Primary Completion Date :||August 2018|
|Estimated Study Completion Date :||February 2019|
Active Comparator: Strerofundin
Days of intervention: 3 days
Active Comparator: 0.9% saline
Days of intervention: 3 days
Procedure: 0.9% saline
- 30 day mortality [ Time Frame: 30 days ]
- Functional neurological outcomes at 6 months based on Extended Glasgow Outcome Scale (GOS-E) [ Time Frame: 180 days ]
- Acid-base balance [ Time Frame: 3 days ]through out intervention period
- Daily mean change in intracranial pressure (ICP) [ Time Frame: 3 days ]through out intervention period
- Episodes of intracranial hypertension [ Time Frame: 3 days ]through out intervention period
- Duration of mechanical ventilation [ Time Frame: 3 days ]through out intervention period
- Length of ICU stay [ Time Frame: 30 days ]through out intervention period
- electrolyte balance [ Time Frame: 3 days ]
- ICU mortality [ Time Frame: 30 days ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02866604
|Contact: Sia S Fu, MSurg, PhDfirstname.lastname@example.org|
|University of Malaya Medical Centre|
|Petaling Jaya, Wilayah Persekutuan Kuala Lumpur, Malaysia, 50603|
|Contact: Sia S Fung, MSurg, PhD +603-79492441 email@example.com|