SOS trial: Hyperosmolar therapy in traumatic brain injury
Research type
Research Study
Full title
Sugar or Salt (SOS) trial: Hyperosmolar therapy in traumatic brain injury
IRAS ID
260350
Contact name
Jane Prewett
Contact email
Sponsor organisation
University of Warwick
Eudract number
2019-001688-66
ISRCTN Number
ISRCTN16075091
Duration of Study in the UK
4 years, 6 months, 0 days
Research summary
Doctors need to know the best treatments for severe brain swelling after head injuries in order to improve outcomes for patients. The two main drugs that are currently used to treat brain swelling are hypertonic saline (a strong salt solution) and mannitol (a sugary solution). Both of these drugs work by reducing brain swelling which helps to reduce pressure on the brain. Currently, it is not known which drug is the most effective treatment. Both drugs have un-desirable side effects (hypertonic saline causes an imbalance of salts in the blood and Mannitol can cause kidney failure). To deliver the best treatment we need to know which is most the safest and most effective.
This study is designed to work out which is the most effective treatment for brain swelling. 638 patients who have sustained a severe injury to the brain and require treatment in intensive care will take part in the study. Half the patients will receive the salty solution and half will receive the sugary solution. Which of the two treatments they receive will be decided randomly using a computer programme.
The study will compare how effective the different drugs are at reducing the pressure on the brain. It will also assess which is better at helping the patient to recover and what the side effects of treatment were. The study team will keep in contact with patients for 12 months after the study to check on how well they have recovered over time. Researchers will also calculate how much each treatment costs and compare this to how beneficial they were.
The study will take place in neurosurgical intensive care units across the UK and is expected to finish at the end of 2023.
REC name
East of England - Essex Research Ethics Committee
REC reference
19/EE/0228
Date of REC Opinion
9 Sep 2019
REC opinion
Further Information Favourable Opinion