Sugar or Salt (SOS) trial: Comparing two current treatments for patients with a brain injury

Phase 1

• Conditions: Increased intracranial pressure following traumatic brain injury; MedDRA version: 20.1Level: LLTClassification code 10060690Term: Traumatic brain injurySystem Organ Class: 100000004863; Therapeutic area: Diseases [C] - Injuries, poisonings, and occupational diseases [C21]

• Registration Number: EUCTR2019-001688-66-GB
• Lead Sponsor: niversity of Warwick

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-07-31
• Last Update Posted: 30 March 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 638

Inclusion Criteria

•Age 16 years or over
•Admission to ICU following traumatic brain injury
•Intracranial pressure (ICP) over 20mmHg for more than 5 minutes despite stage 1 treatments
•Less than 10 days since initial head injury
•Abnormal CT scan consistent with traumatic brain injury

Exclusion criteria:
•Devastating brain injury with withdrawal of treatment anticipated in the next 24 hours
•Pregnancy
•Severe hypernatraemia (defined as serum Na >155mmol/L)

Are the trial subjects under 18? yes
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 383
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 191

Exclusion Criteria

•Devastating brain injury with withdrawal of treatment anticipated in the next 24 hours
•Pregnancy
•Severe hypernatraemia (serum sodium more than 155mmol/L)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified