Fluid administration strategy in severe traumatic brain injury

Restricted versus liberal fluid administration strategy in severe traumatic brain injury (RELIST). A randomized clinical trial

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN23139643

Enrollment

600

Registered

2019-10-29

Start date

2019-11-01

Completion date

Unknown

Last updated

2019-11-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Isolated, non penetrating severe traumatic brain injury (GCS < 9) Injury, Occupational Diseases, Poisoning Intracranial injury

Interventions

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

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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)

Design outcomes

Primary

Measure	Time frame
Percentage of patients with favorable Glasgow Outcome Scale (4 or 5) upon ICU discharge	—

Secondary

Measure	Time frame
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	—

Countries

Saudi Arabia

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026