What is the RRAM study?
It is common for patients in intensive care units (ICUs) to have a kidney injury which prevents their kidney from working properly. If this happens the patients are treated with a machine that takes over the kidney functions and allows their own kidneys to recover. This process is called continuous renal replacement therapy (CRRT). Traditionally as part of this procedure, a medicine called heparin is added to the blood as it enters the CRRT machine to prevent the blood from clotting and clogging the machine. This process is termed anticoagulation. Recently citrate anticoagulation (an alternative to heparin) is being increasingly used in UK ICUs because it may be controllable and cheaper than the traditional heparin. However, both heparin and citrate anticoagulation are associated with different risks to the patient. Currently we do not know if one form of anticoagulation is better than the other as there have not been any direct comparisons of the effects of using heparin and citrate for CRRT. The Renal Replacement Anticoagulant Management (RRAM) study will research the advantages and disadvantages of the two anticoagulant methods for patients with a kidney injury and treated in an ICU.
What does the study involve?
ICNARC holds the data for the Case Mix Programme (CMP) which is the national clinical audit for adult, general critical care units in England, Wales and Northern Ireland. The CMP includes intensive care and combined intensive care and high dependency units in the NHS and collects high quality data on patient outcomes for all adults that are admitted to a critical unit in the UK (more information about the CMP can be found here). As part of the RRAM study we will use this existing high quality data collected for the CMP to help answer the research question. To get a more comprehensive view of the long-term effects of using the different anticoagulation methods to treat people with a kidney injury in the ICU, we will ‘link’ data from the CMP together with the following national datasets that contain information about patient outcomes after leaving hospital:
• Hospital Episode Statistics (HES) inpatient data which contains details of hospital admissions at NHS hospitals in England – held by NHS Digital
• Patient Episodes Data for Wales (PEDW) which collects inpatient data for Wales – held by NHS Wales Informatics Service (NWIS)
• Office for National Statistics (ONS) mortality data which will tell us about patients’ long-term survival – held by NHS Digital
• UK Renal Registry (UKRR) which will tell us if patients go on to have long term kidney problems after leaving the ICU
Managing patient data securely
The process of ‘linking’ the information together from the individual databases will be done by NHS Digital (an organisation that manages access to a database of NHS records). To do so, authorised members of the RRAM team at ICNARC will upload the date of births, home postcodes, NHS numbers, and a unique study number (this is used as the common link between data sets) for each
patient that is eligible for the study to NHS Digital. No patient names will be included in the dataset. This will be done using a secure, password protected online system. All of these pieces of information are sent to help ensure that we identify the right individuals in the other databases. An authorised staff member from NHS Digital will then link the data for each patient together from the different databases using the unique study number and return this to ICNARC where it will be stored securely.
Future data linkage to the PEDW dataset will also take place. As part of this process the RRAM team will securely upload the same patient identifiers and study number for each of the eligible patients to NWIS who will perform the data linkage. NWIS will then return to ICNARC the data for linked patients containing their unique study number (no patient identifiers will be transferred). The PEDW data will then be combined with the data from all of the different databases will be combined into a final dataset using the unique study numbers. At this point all identifiable data (i.e. postcodes, dates of admission/survival data, etc.) will be anonymised by an authorised member of the RRAM team at ICNARC. The data in the final dataset will then be analysed to see the effects of CRRT using heparin or citrate have on the long-term outcomes of patients. This will include looking at patient survival, health care usage (such as number of hospital visits), and whether patients go on to develop kidney failure following discharge from the ICU.
The final data set will not contain any patient identifiable information and will held by ICNARC (the data controller) for a minimum of 10 years. Only approved members of the RRAM team from ICNARC will analyse the data and will only know the unique study number. The results of the study will appear in scientific journals and on this website. It will not be possible to identify any person who has taken part in the study in any reports or articles. No personal or identifiable information will be shared with anyone other than the NHS Digital.
The RRAM study has received ethical (REC reference: 18/SC/0204) and Section 251 approvals (CAG reference: 18/CAG/0070) to undertake the linkage of datasets as described above. The RRAM study processes data under Section 6(1)(f) and Article 9(2)(j) legal basis from the General Data Protection Regulation. This is because ICNARC is a registered charity and the data processing described here is to support scientific and statistical research.
Information collected for the RRAM study is stored on secure servers at ICNARC (office in London) or servers owned by an authorised contractor Red Technology (http://www.redtechnology.com/). ICNARC takes steps to ensure this information is not lost and makes regular back-ups of the data using an authorised contractor (Disaster Recovery Service: http://securemediastorage.co.uk/).
Your rights over your information
The RRAM team do not have access to your personal data. If you have been treated in a hospital participating in the CMP between 1 April 2009 and 31 March 2017 and would like to access, amend, erase or opt out of your personal data being used, you can 1. contact the health care team at the hospital where you were treated who will inform ICNARC or; 2. completing the Data Subject Request Form (click here), stating RRAM as the research study and returning it to ICNARC.
For more information about RRAM please contact:
Dr Doug Gould (Senior Researcher) Doug.Gould@icnarc.org
Professor David Harrison (Head Statistician) David.Harrison@icnarc.org
Your right to complain
If you have a complaint about our use of your information, you can contact the Information Commissioner’s Office via their website at www.ico.org.uk/concerns or write to them at:
Information Commissioner's Office