For patients

Around 184,000 adults are admitted to critical care each year in the UK. Around half have a sudden worsening in kidney function that happens as part of their illness, called acute kidney injury (AKI). This rapid decline in kidney function frequently causes more acid to build up in the blood (known as acidosis) which can cause further harm. MOSAICC is a national research study which aims to better understand whether treatment of critically ill patients with AKI and acidosis with sodium bicarbonate is superior to no sodium bicarbonate.

This treatment has the potential to both increase survival and avoid kidney replacement therapy (KRT), which is invasive and resource-intensive. A recent trial investigating the use of sodium bicarbonate in critically ill patients found a significant reduction in 28-day mortality, and use of KRT in a subgroup of patients with AKI. However, more research is needed to provide better evidence for the use of sodium bicarbonate for these patients.

This study is sponsored by The Intensive Care National Audit & Research Centre (ICNARC), based in the UK, and they are the people who control the data that is collected and used for the study. This study is funded by the National Institute for Health Research – Health Technology Assessment Programme.  The National Institute of Health Research is an organisation that gives government funding for health and health-related technology projects. To find out more about the National Institute for Health Research, please visit their website.

To help us manage and meet the objectives of the study, ICNARC collects and holds personal data about trial participants. This information (such as date of birth, NHS number, health data and contact details) was collected by the research/audit team at the hospital where you became involved in the study. This information was securely submitted to ICNARC. The research team will also collect information on your survival from your medical records until the end of the study.

Your private information is important to us, and we want to protect it from being seen by anyone who isn’t connected with the study. One of the ways we do this is by allocating each participant a unique code number, called a ‘trial number’. This means we can track your recovery specifically to you, without your personal information being seen by anyone outside the team. The term used for this process is ‘pseudonymised’.

ICNARC will follow-up on your well-being by requesting some important health information, including survival, hospital stay, acute kidney injury and kidney replacement therapy data, from national databases held by NHS Digital, Digital Health and Care Wales (formerly NHS Wales Informatics Service) and the UK Renal Registry. These are organisations that manage access to national database of NHS records. To obtain this important information, the MOSAICC trial team will send your date of birth, home postcode, NHS number and unique trial number (required to ensure you can be identified in the database correctly) to NHS Digital using a secure, password-protected online file exchange service. An authorised person from NHS Digital will then link the identifiers to the national records and securely send back the relevant data for storage on the secure MOSAICC trial database. The same process will be carried out with Digital Health and Care Wales and the UK Renal Registry.

We will also use these data to send a questionnaire on health and well-being to participants, one at 90 days after entry into the study and one at 12 months after entry into the study. If you opt to receive the questionnaire by email, then we will send you a link to the questionnaire using SmartSurvey. SmartSurvey’s privacy policy can be found here.

All of the information is held in a secure password protected database, with access only by authorised research team members at your hospital and at ICNARC. Information collected during MOSAICC is stored on ICNARC’s secure servers which are owned by an authorised contractor called Exponential-e. ICNARC takes steps to ensure this information is not lost and makes regular back-ups of the data.

Once the study is finished, statisticians from ICNARC will analyse the information to find out which treatment was most effective. A member of our team based at the London School of Hygiene and Tropical Medicine will help with some of the analyses but will only have access to pseudonymised data and will not be able to identify any of the participants.

At the end of the study, ICNARC will keep identifiable information (personal data) about you for no longer than one year after the study has finished. The information will be then anonymised so that you can no longer be identified (unless you have agreed otherwise). It will not be possible to identify any person who has taken part in the study in any reports or articles.

ICNARC process data for this study under the legitimate interest legal basis. This is because ICNARC is a registered charity and the data processing described here is to support scientific and statistical research. Your rights to access, change or move your information are limited, as we need to manage your information in specific ways in order for the research to be reliable and accurate. If you withdraw from the study, we will keep the information about you that we have already obtained. To safeguard your rights, we will use the minimum personally-identifiable information possible. There is no automated decision-making or profiling.

If, when you consented to take part, you indicated that you did not want us to either obtain the above information from NHS Digital or Digital Health and Care Wales, or to send you a questionnaire, we will not process your data for these purposes. As you were very unwell at the time, a relative, close friend or an Professional Legal Representative may have provided their consent on your behalf. In either situation, you can opt out if you no longer wish that we process your data in these ways (contact details below).

More information about MOSAICC is available on this website. If you have any other questions or wish to opt out or withdraw, please contact:

Catherine Oversby      Trial Manager            catherine.oversby@icnarc.org                 020 7269 9277

ICNARC’s overarching privacy notice, and details of our Data Protection Officer, is available here.

If you have a complaint about our use of your information, you can contact the Information Commissioner’s Office via their website or write to them at:

Information Commissioner’s Office
Wycliffe House
Water Lane
Wilmslow
Cheshire
SK9 5AF