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

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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
Sponsor:
Information provided by (Responsible Party):
University of Malaya

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.

Condition or disease Intervention/treatment Phase
Brain Injuries Procedure: Sterofundin Procedure: 0.9% saline Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Strerofundin
Days of intervention: 3 days
Procedure: Sterofundin
Active Comparator: 0.9% saline
Days of intervention: 3 days
Procedure: 0.9% saline



Primary Outcome Measures :
  1. 30 day mortality [ Time Frame: 30 days ]
  2. Functional neurological outcomes at 6 months based on Extended Glasgow Outcome Scale (GOS-E) [ Time Frame: 180 days ]

Secondary Outcome Measures :
  1. Acid-base balance [ Time Frame: 3 days ]
    through out intervention period

  2. Daily mean change in intracranial pressure (ICP) [ Time Frame: 3 days ]
    through out intervention period

  3. Episodes of intracranial hypertension [ Time Frame: 3 days ]
    through out intervention period

  4. Duration of mechanical ventilation [ Time Frame: 3 days ]
    through out intervention period

  5. Length of ICU stay [ Time Frame: 30 days ]
    through out intervention period

  6. electrolyte balance [ Time Frame: 3 days ]
  7. ICU mortality [ Time Frame: 30 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02866604


Contacts
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Contact: Sia S Fu, MSurg, PhD +603-79492441 sfsia02@um.edu.my

Locations
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Malaysia
University of Malaya Medical Centre Not yet recruiting
Petaling Jaya, Wilayah Persekutuan Kuala Lumpur, Malaysia, 50603
Contact: Sia S Fung, MSurg, PhD    +603-79492441    sfsia02@um.edu.my   
Sponsors and Collaborators
University of Malaya

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Responsible Party: University of Malaya
ClinicalTrials.gov Identifier: NCT02866604     History of Changes
Other Study ID Numbers: 201510-1766
First Posted: August 15, 2016    Key Record Dates
Last Update Posted: October 26, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by University of Malaya:
Traumatic brain injury
isotonic balanced fluid

Additional relevant MeSH terms:
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Brain Injuries
Brain Injuries, Traumatic
Wounds and Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System