Fluid administration strategy in severe traumatic brain injury

Not Applicable

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

• Registration Number: ISRCTN23139643
• Lead Sponsor: King Saud Medical City

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-10-29
• Last Update Posted: 25 November 2019
• Study Completion: 2020-12-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 600

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

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)

Study & Design

• Study Type: Interventional
• Study Design: Not specified