Brain InjuriesFLUIDNCT02866604
Comparison of an Isotonic Balanced Fluid, Sterofundin® , With 0.9% Saline in Traumatic Brain Injury(TBI)
A study testing Sterofundin and 0.9% saline in people with Brain Injuries, run by University of Malaya at 1 site in Malaysia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Injuries
- What is being tested?
- Sterofundin and 0.9% saline
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteMalaysia
- Study dates
- Oct 2016to Feb 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Pregnancy
- Polytrauma
- Cardiac arrest at presentation
- GCS of three with bilateral fixed dilated pupils,
- Evidence of severe cardiac, respiratory, renal or liver dysfunction
Trial locations and contacts
1 site in 1 country.
Malaysia1 site
University of Malaya Medical Centre
Petaling Jaya, Kuala Lumpur, 50603
Sia S Fung, MSurg, PhD, +603-79492441, sfsia02@um.edu.my
About this study
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.
Read the 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.
- Conditions
- Brain Injuries
- Being tested
- Sterofundin, 0.9% saline
- Keywords
- Traumatic brain injury, isotonic balanced fluid
- Medical subject headings
- Brain Injuries, Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SterofundinProcedure or surgery
0.9% salineProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Strerofundin | Active comparator | Days of intervention: 3 days Receives: Procedure: Sterofundin |
| 0.9% saline | Active comparator | Days of intervention: 3 days Receives: Procedure: 0.9% saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
30 day mortality
Measured: 30 days
Functional neurological outcomes at 6 months based on Extended Glasgow Outcome Scale (GOS-E)
Measured: 180 days
Secondary outcomes (7)
Acid-base balance
through out intervention period
Measured: 3 days
Daily mean change in intracranial pressure (ICP)
through out intervention period
Measured: 3 days
Episodes of intracranial hypertension
through out intervention period
Measured: 3 days
Duration of mechanical ventilation
through out intervention period
Measured: 3 days
Length of ICU stay
through out intervention period
Measured: 30 days
electrolyte balance
Measured: 3 days
ICU mortality
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2016 (estimated)
- Study startOct 2016
- Primary completionAug 2018 (estimated)
- Study completionFeb 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain InjuriesStudies of the same condition, open and under way.
- More trials run by University of MalayaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Malaya
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02866604
- Sponsor's protocol ID
- 201510-1766
- Acronym
- FLUID
- Status last verified
- Oct 2016
- First submitted
- 23 May 2016
- Last updated
- 26 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of an Isotonic Balanced Fluid, Sterofundin® , With 0.9% Saline in Traumatic Brain Injury(TBI)
- ClinicalTrials.gov ID
- NCT02866604
- Acronym / sponsor ID
- FLUID / 201510-1766
- Conditions
- Brain Injuries
- Keywords
- Traumatic brain injury, isotonic balanced fluid
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- University of MalayaUniversity, hospital or other
- Study start
- Oct 2016
- Primary completion
- Aug 2018 (estimated)
- Study completion
- Feb 2019 (estimated)
- First posted
- 15 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Strerofundin | Active comparator | Procedure: SterofundinDays of intervention: 3 days |
| 0.9% saline | Active comparator | Procedure: 0.9% salineDays of intervention: 3 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- Pregnancy
- Polytrauma
- Cardiac arrest at presentation
- GCS of three with bilateral fixed dilated pupils,
- Evidence of severe cardiac, respiratory, renal or liver dysfunction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sterofundin | Procedure or surgery | Strerofundin |
| 0.9% saline | Procedure or surgery | 0.9% saline |
Primary outcome
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
7 secondary outcomes
Acid-base balance
Time frame: 3 days
Daily mean change in intracranial pressure (ICP)
Time frame: 3 days
Episodes of intracranial hypertension
Time frame: 3 days
Duration of mechanical ventilation
Time frame: 3 days
Length of ICU stay
Time frame: 30 days
electrolyte balance
Time frame: 3 days
ICU mortality
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sterofundin and 0.9% saline in people with Brain Injuries, run by University of Malaya at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sia S Fu, MSurg, PhD (+603-79492441, sfsia02@um.edu.my), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
30 day mortality (time frame: 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2016.