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

Phase 3

• Conditions: Traumatic brain injury; Injury, Occupational Diseases, Poisoning

• Registration Number: ISRCTN16075091
• Lead Sponsor: niversity Hospitals Birmingham NHS Foundation Trust

Brief Summary

2020 Protocol article in https://doi.org/10.1177/1751143720901690 protocol (added 06/08/2020)

Detailed Description

Not available

Study Timeline

• Study Start: 2019-04-16
• Last Update Posted: 29 April 2024
• Study Completion: 2026-02-28

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 468

Inclusion Criteria

1. Age 16 years or over
2. Admission to ICU following traumatic brain injury
3. ICP > 20mmHg for more than 5 minutes despite stage 1 procedures
4. <10 days from initial head injury
5. Abnormal CT scan consistent with traumatic brain injury

Exclusion Criteria

Current participant exclusion criteria as of 21/12/2023:
1. Devastating brain injury with withdrawal of treatment anticipated in the next 24 hours
2. Pregnancy
3. Severe hypernatraemia (Na > 155 mmol/L)
4. 2 or more prior doses of hyperosmolar therapy given on ICU

Previous participant exclusion criteria as of 06/08/2020:
1. Devastating brain injury with withdrawal of treatment anticipated in the next 24 hours
2. Pregnancy
3. Severe hypernatraemia (Na > 155 mmol/L)

Previous participant exclusion criteria from 10/06/2019 to 06/08/2020:
1. Devastating brain injury with withdrawal of treatment anticipated in the next 24 hours
2. Pregnancy
3. Severe hypernatraemia (Na > 160 mmol/L)

Original participant exclusion criteria:
1. Unsurvivable injuries
2. Pregnancy
3. Severe hypernatraemia (Na > 160 mmol/L)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
eurological outcome measured by patient/relative/clinician completion of the Extended Glasgow Outcome Scale (GOS-E) questionnaire at 6 months