Ignite Creation Date:
2025-12-24 @ 9:09 PM
Ignite Modification Date:
2025-12-31 @ 7:49 AM
Study NCT ID:
NCT02866604
Status:
UNKNOWN
Last Update Posted:
2016-10-26
First Post:
2016-05-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of an Isotonic Balanced Fluid, Sterofundin® , With 0.9% Saline in Traumatic Brain Injury(TBI)
Sponsor:
University of Malaya
Organization:
Study Overview
Official Title:
Comparison of an Isotonic Balanced Fluid, Sterofundin® , With 0.9% Saline in Traumatic Brain Injury(TBI)
Status:
UNKNOWN
Status Verified Date:
2016-10
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FLUID
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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: