Condition category
Injury, Occupational Diseases, Poisoning
Date applied
23/10/2019
Date assigned
29/10/2019
Last edited
28/10/2019
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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

https://www.ksmc.med.sa

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

Publication citations

Additional files

Editorial Notes

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