Sugar or Salt (“SOS”): a protocol for a UK multicentre randomised trial of mannitol and hypertonic saline in severe traumatic brain injury and intracranial hypertension

AbstractHyperosmolar solutions are widely used to treat raised intracranial pressure (ICP) following severe traumatic brain injury (TBI). Although mannitol has historically been the most frequently administered, hypertonic saline (HTS) solutions are increasingly being used. However, definitive evidence regarding their comparative effectiveness is lacking. The Sugar or Salt (SOS) Trial is a UK randomised, allocation concealed open label multicentre pragmatic trial designed to determine the clinical and cost-effectiveness of hypertonic saline (HTS) compared with mannitol in the management of patients with severe TBI. Patients requiring intensive care unit admission and intracranial pressure (ICP) monitoring post-TBI will be allocated at random to receive equi-osmolar boluses of either mannitol or HTS following failure of routine first line measures to control ICP. The primary outcome for the study will be the Extended Glasgow Outcome Scale (GOS-E) assessed at 6 months after randomisation. Results will inform current clinical practice in the routine use of hyperosmolar therapy as well as assess the impact of potential side effects. Pre-planned longer term clinical and cost effectiveness analyses will further inform the use of these treatments.

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Sugar or salt (“SOS”): A protocol for a UK multicentre randomised trial of mannitol and hypertonic saline in severe traumatic brain injury and intracranial hypertension

Journal of the Intensive Care Society ◽

10.1177/1751143720901690 ◽

2020 ◽

pp. 175114372090169

Author(s):

MJ Rowland ◽

T Veenith ◽

C Scomparin ◽

MH Wilson ◽

PJ Hutchinson ◽

...

Keyword(s):

Traumatic Brain Injury ◽

Cost Effectiveness ◽

Brain Injury ◽

Intracranial Pressure ◽

Hypertonic Saline ◽

Severe Traumatic Brain Injury ◽

Randomised Trial ◽

Pragmatic Trial ◽

Open Label ◽

The Impact

Hyperosmolar solutions are widely used to treat raised intracranial pressure following severe traumatic brain injury. Although mannitol has historically been the most frequently administered, hypertonic saline solutions are increasingly being used. However, definitive evidence regarding their comparative effectiveness is lacking. The Sugar or Salt Trial is a UK randomised, allocation concealed open label multicentre pragmatic trial designed to determine the clinical and cost-effectiveness of hypertonic saline compared with mannitol in the management of patients with severe traumatic brain injury. Patients requiring intensive care unit admission and intracranial pressure monitoring post-traumatic brain injury will be allocated at random to receive equi-osmolar boluses of either mannitol or hypertonic saline following failure of routine first-line measures to control intracranial pressure. The primary outcome for the study will be the Extended Glasgow Outcome Scale assessed at six months after randomisation. Results will inform current clinical practice in the routine use of hyperosmolar therapy as well as assess the impact of potential side effects. Pre-planned longer term clinical and cost effectiveness analyses will further inform the use of these treatments.

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23.4% Hypertonic Saline and Intracranial Pressure in Severe Traumatic Brain Injury Among Children

Pediatric Critical Care Medicine ◽

10.1097/pcc.0000000000001867 ◽

2019 ◽

Vol 20 (5) ◽

pp. 466-473 ◽

Cited By ~ 6

Author(s):

Andrew G. Wu ◽

Uzma Samadani ◽

Tina M. Slusher ◽

Lei Zhang ◽

Andrew W. Kiragu

Keyword(s):

Traumatic Brain Injury ◽

Brain Injury ◽

Intracranial Pressure ◽

Hypertonic Saline ◽

Severe Traumatic Brain Injury

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Erratum: Hypertonic saline reduces cumulative and daily intracranial pressure burdens after severe traumatic brain injury

Journal of Neurosurgery ◽

10.3171/2015.10.jns132545a ◽

2016 ◽

Vol 124 (1) ◽

pp. 277

Author(s):

Halinder S. Mangat

Keyword(s):

Traumatic Brain Injury ◽

Brain Injury ◽

Intracranial Pressure ◽

Hypertonic Saline ◽

Severe Traumatic Brain Injury

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A Propensity Score Analysis of the Impact of Invasive Intracranial Pressure Monitoring on Outcomes after Severe Traumatic Brain Injury

Journal of Neurotrauma ◽

10.1089/neu.2015.4015 ◽

2016 ◽

Vol 33 (9) ◽

pp. 853-858 ◽

Cited By ~ 18

Author(s):

Deepak Agrawal ◽

Krishnan Raghavendran ◽

Douglas E. Schaubel ◽

Mahesh C. Mishra ◽

Venkatakrishna Rajajee

Keyword(s):

Traumatic Brain Injury ◽

Brain Injury ◽

Intracranial Pressure ◽

Propensity Score ◽

Severe Traumatic Brain Injury ◽

Propensity Score Analysis ◽

Intracranial Pressure Monitoring ◽

Pressure Monitoring ◽

Score Analysis ◽

The Impact

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Comparison of weight-based dosing versus fixed dosing of 23.4% hypertonic saline for intracranial pressure reduction in patients with severe traumatic brain injury

Journal of Emergencies Trauma and Shock ◽

10.4103/jets.jets_66_19 ◽

2020 ◽

Vol 13 (4) ◽

pp. 252

Author(s):

Donald Johnson ◽

Kirsten Busey ◽

Jason Ferreira ◽

Petra Aldridge ◽

Marie Crandall

Keyword(s):

Traumatic Brain Injury ◽

Brain Injury ◽

Intracranial Pressure ◽

Hypertonic Saline ◽

Severe Traumatic Brain Injury ◽

Pressure Reduction

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Hypertonic saline in severe traumatic brain injury: a systematic review and meta-analysis of randomized controlled trials

CJEM ◽

10.1017/cem.2016.12 ◽

2016 ◽

Vol 18 (2) ◽

pp. 112-120 ◽

Cited By ~ 26

Author(s):

Elyse Berger-Pelleiter ◽

Marcel Émond ◽

François Lauzier ◽

Jean-François Shields ◽

Alexis F. Turgeon

Keyword(s):

Systematic Review ◽

Traumatic Brain Injury ◽

Brain Injury ◽

Intracranial Pressure ◽

Randomized Controlled Trials ◽

Hypertonic Saline ◽

Severe Traumatic Brain Injury ◽

Controlled Trials ◽

Cochrane Central Register ◽

Randomized Controlled

AbstractObjectivesHypertonic saline solutions are increasingly used to treat increased intracranial pressure following severe traumatic brain injury. However, whether hypertonic saline provides superior management of intracranial pressure and improves outcome is unclear. We thus conducted a systematic review to evaluate the effect of hypertonic saline in patients with severe traumatic brain injury.MethodsTwo researchers independently selected randomized controlled trials studying hypertonic saline in severe traumatic brain injury and collected data using a standardized abstraction form. No language restriction was applied. We searched MEDLINE, EMBASE, Cochrane Central Register of Controlled Trials, Scopus, Web of Science, and BIOSIS databases. We searched grey literature via OpenGrey and National Technical Information Service databases. We searched the references of included studies and relevant reviews for additional studies.ResultsEleven studies (1,820 patients) were included. Hypertonic saline did not decrease mortality (risk ratio 0.96, 95% confidence interval [CI] 0.83 to 1.11, I2=0%) or improve intracranial pressure control (weighted mean difference −1.25 mm Hg, 95% CI −4.18 to 1.68, I2=78%) as compared to any other solutions. Only one study reported monitoring for adverse events with hypertonic saline, finding no significant differences between comparison groups.ConclusionsWe observed no mortality benefit or effect on the control of intracranial pressure with the use of hypertonic saline when compared to other solutions. Based on the current level of evidence pertaining to mortality or control of intracranial pressure, hypertonic saline could thus not be recommended as a first-line agent for managing patients with severe traumatic brain injury.

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Comparison of mannitol and hypertonic saline in the treatment of severe brain injuries

Journal of Neurosurgery ◽

10.3171/2010.5.jns091685 ◽

2011 ◽

Vol 114 (2) ◽

pp. 545-548 ◽

Cited By ~ 72

Author(s):

Nikolaos Sakellaridis ◽

Elias Pavlou ◽

Stylianos Karatzas ◽

Despina Chroni ◽

Konstantinos Vlachos ◽

...

Keyword(s):

Traumatic Brain Injury ◽

Brain Injury ◽

Intracranial Pressure ◽

Hypertonic Saline ◽

Severe Traumatic Brain Injury ◽

Brain Injuries ◽

Treatment Protocol ◽

Venous Catheter ◽

Duration Of Action ◽

The Mean

Object The purpose of this study was to compare the effects of mannitol and hypertonic saline in doses of similar osmotic burden for the treatment of intracranial hypertension in patients with severe traumatic brain injury. Methods The authors used an alternating treatment protocol to compare the effect of hypertonic saline with that of mannitol given for episodes of increased intracranial pressure in patients treated for severe head injury at their hospital during 2006–2008. Standard guidelines for the management of severe traumatic brain injury were followed. Elevated intracranial pressure (ICP) was treated either with mannitol or hypertonic saline. Doses of similar osmotic burden (mannitol 20%, 2 ml/kg, infused over 20 minutes, or saline 15%, 0.42 ml/kg, administered as a bolus via a central venous catheter) were given alternately to the individual patient with severe brain injury during episodes of increased pressure. The dependent variables were the extent and duration of reduction of increased ICP. The choice of agent for treatment of the initial hypertensive event was determined on a randomized basis; treatment was alternated for every subsequent event in each individual patient. Reduction of ICP and duration of action were recorded after each event. Results obtained after mannitol administration were statistically compared with those obtained after hypertonic saline administration. Results Data pertaining to 199 hypertensive events in 29 patients were collected. The mean decrease in ICP obtained with mannitol was 7.96 mm Hg and that obtained with hypertonic saline was 8.43 mm Hg (p = 0.586, equal variances assumed). The mean duration of effect was 3 hours 33 minutes for mannitol and 4 hours 17 minutes for hypertonic saline (p = 0.40, equal variances assumed). Conclusions No difference between the 2 medications could be found with respect to the extent of reduction of ICP or duration of action.

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