Plain English Summary
Background and study aims
Traumatic Brain Injury (TBI) is an injury to the brain caused by a trauma to the head (head injury). There are many possible causes, including road traffic accidents, assaults, falls and accidents at home or at work. Since TBI is a major health problem all efforts are being made to improve the outcomes of TBI victims. None of the TBI management guidelines addresses the fluid balance
Who can participate?
Patients aged 14 or above with severe TBI
What does the study involve?
Our study will have two groups with random assignment. In one group we will treat the patients following our ICU protocol which is adopted from Brain Trauma Foundation guidelines.
The second group will also follow the same protocol of management, and will be treated exactly the same way, but we will aim for maintaining a 24 hours balance of +/- 500 ml, while not interfering with the management hemodynamic targets, this will be done in the first 7 days after the trauma.
Upon ICU discharge we will evaluate the patients outcome using a score that ranges from 1 - 5 for the functionality of the patient (5 is best, 1 is worst).
Our hypothesis is that maintaining a balance of fluids will result in better outcomes.
What are the possible benefits and risks of participating?
Possible benefits include achievement of favourable Glasgow Outcome Score (4 or 5) upon ICU discharge, fewer ventilator days and thus fewer complications related to mechanical ventilation and less ICU and hospital stay. We are expecting no risks more than would be expected for a critically ill patient treated in ICU
Where is the study run from?
King Saud Medical City, Saudi Arabia
When is the study starting and how long is it expected to run for?
November 2019 to December 2020
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Dr Waleed Aletreby
waleedaletreby@gmail.com
Trial website
Contact information
Type
Scientific
Primary contact
Dr Waleed Aletreby
ORCID ID
http://orcid.org/0000-0001-8387-1829
Contact details
Al- Shemaisi
PO Box 331905
Riyadh
11373 - Shemaisi
Saudi Arabia
+966 543531552
wthashim@ksmc.med.sa
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov number
Nil known
Protocol/serial number
H1IR - 17 - DEC 18 - 01
Study information
Scientific title
Restricted versus liberal fluid administration strategy in severe traumatic brain injury (RELIST). A randomized clinical trial
Acronym
RELIST
Study hypothesis
Maintaining a zero balance of fluids for TBI patients will result in better outcomes as compared to a positive balance
Ethics approval
Approved 20/06/2019, IRB of King Saud Medical City (Saudi Arabia, Riyadh, 11373; irb@ksmc.med.sa; +966 0114355555- ext 2345) ref: H1IR-17-DEC 18-01
Study design
Open-label randomized controlled trial of two arms compared head to head
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet.
Condition
Isolated, non penetrating severe traumatic brain injury (GCS < 9)
Intervention
The study will recruit patients aged 14 or above (14 is the age of adulthood in Saudi Arabia) who are victims of severe TBI (GCS < 9) within 24 hours of the incidence of trauma. The main intervention of the study is controlling the fluid balance in the first 7 days to keep it ± 500 ml /day as compared to no interference with balance in the control group. Otherwise, both groups are treated similarly, according to our unit protocol adopted from guidelines of Brain Trauma Foundation.
Intervention: Maintaining a 24 hours balance of +/- 500 ml , for the first 7 days. While following the TBI protocol as per the guidelines. Daily balance may be controlled using diuretics, and if needed vasopressors to maintain hemodynamic targets.
Control: This group also follows the TBI protocol as per the guidelines, except there is no interference with the fluid balance
Intervention type
Mixed
Phase
Drug names
Primary outcome measure
Percentage of patients with favorable Glasgow Outcome Scale (4 or 5) upon ICU discharge
Secondary outcome measures
1. Percentage of patients with favorable GOS at 6 months
2. ICU length of stay and mortality
3. Development of pulmonary oedema
4. Days on TBI management protocol
5. Days on mechanical ventilation
Overall trial start date
01/01/2019
Overall trial end date
31/12/2020
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Age ≥ 14 years
2. Severe TBI (GCS <9)
3. Within 24 hours of the incidence of trauma provided that the resuscitation phase is complete (post-resuscitation phase)
4. Isolated non-penetrating head injury
5. Clinical necessity for ICP management per BTF recommendations
6. Mechanically ventilated, without any evidence of respiratory dysfunction (P/F ration ≥ 250).
7. Hemodynamically stable or on vasopressor support for standardized CPP management according to BTF recommendations: MAP ≥ 65 mmHg
8. SBP ≥ 90 mmHg
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
600
Participant exclusion criteria
1. Pregnancy
2. Neurological examination suggesting eminent brain death
3. Multiple trauma
4. Severe chronic heart failure (NYHA 4)
5. Bleeding disorders and/or ICP monitoring contraindicated for other reasons.
6. Impaired renal function (Creatinine > 200 mmol/L)
7. Patients without fixed address (impossible to follow-up)
Recruitment start date
01/11/2019
Recruitment end date
31/10/2020
Locations
Countries of recruitment
Saudi Arabia
Trial participating centre
King Saud Medical City
Al-shemaisi
Riyadh
11373 - Shemaisi
Saudi Arabia
Sponsor information
Organisation
King Saud Medical City
Sponsor details
Riyadh Badiaa
Riyadh
11373
Saudi Arabia
+966 (0)543531552
ahmadwaleed2005@gmail.com
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Other
Funder name
Investigator initiated and funded
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
We intend to publish the results of the trial in peer reviewed journals.
IPD sharing statement:
The datasets generated during and/or analysed during the current study are not expected to be made available due to lack of consent from participants to share their data.
Intention to publish date
01/01/2021
Participant level data
Not expected to be available
Basic results (scientific)
Publication list