Rowland, Matthew J, Veenith, Tonny, Scomparin, Charlotte, Wilson, Mark H., Hutchinson, Peter J., Kolias, Angelos, Lall, Ranjit, Regan, Scott, Mason, James, Andrews, Peter J. D., Horner, Daniel, Naisbitt, Jay, Devrell, Anne, Malins, Andrew, Dark, Paul, McAuley, Danny and Perkins, Gavin D. (2021) “Sugar or Salt” (SOS) trial protocol summary. Journal of the Intensive Care Society . doi:10.1177/17511437211035515

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Abstract

Objective: Does hyperosmolar therapy (mannitol or hypertonic saline) in traumatic brain injury (TBI) improve neurological function clinically and cost- effectively at 6 months?

Design: Multi-centre, open label, randomised controlled clinical and cost effectiveness trial with an internal pilot

Setting: Intensive Care Units (ICUs) within NHS hospitals treating patients with TBI

Target population: Adult patients (aged >16 years) with severe TBI and raised intracranial pressure (ICP)

Inclusion criteria: Patients aged ≥16 years old, admitted to ICU following TBI within 10 days from initial primary head injury, abnormal CT scan consistent with TBI and an ICP >20 mmHg for more than 5 mins despite stage 1 procedures

Exclusion criteria: Devastating brain injury with withdrawal of life sustaining treatment anticipated in the next 24 hours, pregnancy and severe hypernatraemia (serum Na > 155 mmol/L)

Planned sample size: 319 per group (638 in total)

Interventions: 2 ml/kg 20% mannitol intravenous bolus and 2 ml/kg 3% hypertonic saline (HTS) intravenous bolus (or equivalent osmolar dose of HTS using the concentration used locally by participating study centres)

Outcome measures:

Primary outcome: Extended Glasgow Outcome Scale (GOS-E) measured at 6 months after randomisation.

Secondary outcome measures: Efficacy – ICP control (during period of monitoring in ICU, progression to stage 3 therapies and requirement for stage 3 therapies to control ICP, Resource use – organ support requirements during ICU, critical care length of stay and hospital length of stay. Patient outcomes – longer term neurological outcomes (Modified Oxford Handicap Scale (mOHS) at discharge and GOS-E at 12 months), Survival (to hospital discharge – defined as the time at which the patient is discharged from the hospital regardless of neurological status, outcome or destination and at 3 months, 6 months and 12 months) and quality of life (EQ-5D-5L at hospital discharge, 3 months, 6 months and 12 months post-TBI)

Blinding: Open label with blinded assessment of primary and secondary outcomes

Follow up period: Up to 12 months post-randomisation

Planned trial period: From 01/06/2019 to 01/12/2023 (total of 54 months)

Trial Registration: ISRCTN16075091

Declaration of conflicting interests
The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Funding
The author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: National Institute of Health Research Health Technology Assessment Programme (HTA reference 17/120/01).

Item Type:	Journal Item
Divisions:	Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School > Clinical Trials Unit Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School > Health Sciences Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School
SWORD Depositor:	Library Publications Router
Journal or Publication Title:	Journal of the Intensive Care Society
Publisher:	Sage Publications Ltd.
ISSN:	1751-1437
Official Date:	28 October 2021
Dates:	Date Event 28 October 2021 Published
DOI:	10.1177/17511437211035515
Status:	Peer Reviewed
Publication Status:	Published
Access rights to Published version:	Open Access (Creative Commons)

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