Fluid administration strategy in severe traumatic brain injury

ISRCTN ISRCTN23139643
DOI https://doi.org/10.1186/ISRCTN23139643
Secondary identifying numbers H1IR - 17 - DEC 18 - 01
Submission date
23/10/2019
Registration date
29/10/2019
Last edited
28/10/2019
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Injury, Occupational Diseases, Poisoning
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

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

Contact information

Dr Waleed Aletreby
Scientific

Al- Shemaisi
PO Box 331905
Riyadh
11373 - Shemaisi
Saudi Arabia

ORCiD logoORCID ID 0000-0001-8387-1829
Phone +966 543531552
Email wthashim@ksmc.med.sa

Study information

Study designOpen-label randomized controlled trial of two arms compared head to head
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use contact details to request a participant information sheet.
Scientific titleRestricted versus liberal fluid administration strategy in severe traumatic brain injury (RELIST). A randomized clinical trial
Study acronymRELIST
Study objectivesMaintaining a zero balance of fluids for TBI patients will result in better outcomes as compared to a positive balance
Ethics approval(s)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
Health condition(s) or problem(s) studiedIsolated, non penetrating severe traumatic brain injury (GCS < 9)
InterventionThe 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 typeMixed
Primary outcome measurePercentage of patients with favorable Glasgow Outcome Scale (4 or 5) upon ICU discharge
Secondary outcome measures1. 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 study start date01/01/2019
Completion date31/12/2020

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants600
Key inclusion criteria1. 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
Key exclusion criteria1. 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)
Date of first enrolment01/11/2019
Date of final enrolment31/10/2020

Locations

Countries of recruitment

  • Saudi Arabia

Study participating centre

King Saud Medical City
Al-shemaisi
Riyadh
11373 - Shemaisi
Saudi Arabia

Sponsor information

King Saud Medical City
Hospital/treatment centre

Riyadh Badiaa
Riyadh
11373
Saudi Arabia

Phone +966 (0)543531552
Email ahmadwaleed2005@gmail.com
Website https://www.ksmc.med.sa
ROR logo "ROR" https://ror.org/03aj9rj02

Funders

Funder type

Other

Investigator initiated and funded

No information available

Results and Publications

Intention to publish date01/01/2021
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot expected to be made available
Publication and dissemination planWe intend to publish the results of the trial in peer reviewed journals.
IPD sharing planThe 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.

Editorial Notes

28/10/2019: Trial’s existence confirmed by IRB of King Saud Medical City