Plain English Summary
Background and study aims
Acute Kidney Injury (AKI) refers to an abrupt drop in kidney function and is often seen in unwell patients who require hospitalisation. In the short term, AKI increases the complexity and duration of treatment and reduces the chance of patient survival. In many patients that do recover, there is also an improvement in kidney function. It is possible that episodes of AKI may have effects on patients in the longer term, leading to kidney damage over time or reducing long-term survival. There is a lack of good quality research in this area. This study intends to find out the long-term effects of AKI on the development and progression of long-term kidney disease as well as the effects of AKI on patient survival.
Who can participate?
Hospitalised patients with similar characteristics, one group who did sustain AKI and one group who did not.
What does the study involve?
Patients will be identified through routine blood tests to measure kidney function that were collected during their hospital stay. They will be invited to participate in the study about three months after these blood tests were taken, by which time they will have recovered from their hospital stay. We will then collect three routine blood tests to measure kidney function: the first at the start of the study (i.e., three months after the episode of AKI to assess the degree of recovery of kidney function); the second at nine months (1 year after the episode of AKI) and the third at 33 months (three years after the episode of AKI). These blood tests can be taken in the community at the patients GP surgery or local blood-taking clinic. Samples from all three blood and urine tests will be stored for further testing. Stored samples will be disposed of at the end of the study. We will confirm the medical details of patients from hospital records and we will monitor health status (including cause of death for any patients who die) through the records kept at the NHS Information Centre.
What are the possible benefits and risks of participating?
Taking part in this study will ensure that the patients kidney function is monitored regularly. This will allow us to pick up any abnormalities and respond to them. The results will be reviewed by our researchers and a specialist doctor. Their GPs will be given advice about how to respond to abnormal results. There are no major disadvantages, risks or side effects. The blood tests will take about 5 minutes of your time and there may be a small amount of discomfort.
Where is the study run from?
The Department of Renal Medicine, Royal Derby Hospital, UK.
When is the study starting and how long is it expected to run for?
The study started in March 2013 and is expected to run for two years.
Who is funding the study?
1. The Bupa Foundation (UK)
2. British Renal Society (UK)
3. Kidney Research (UK)
Who is the main contact?
Dr Nick Selby
nick.selby@nhs.net
Trial website
Contact information
Type
Scientific
Primary contact
Dr Nick Selby
ORCID ID
http://orcid.org/0000-0003-0351-8326
Contact details
Uttoxeter Road
Derby
DE22 3NE
United Kingdom
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
13864
Study information
Scientific title
Defining the long-term consequences of acute kidney injury: the Aki Risk In Derby (ARID) study
Acronym
ARID
Study hypothesis
The research questions that the study has been designed to address are as follows:
1. Does AKI lead to the onset or progression of chronic kidney disease?
2. Does AKI increase the risk of cardiovascular events?
3. Does AKI confer an increased risk of long-term mortality?
4. Can we develop strategies to identify those patients at higher risk of worse long-term outcomes following an episode of AKI?
On 22/05/2014 the target number of participants was changed from 1802 to 1084.
Ethics approval
Derbyshire Research Ethics Committee, 12/EM/0441; First MREC approval date 06/12/2012
Study design
Non-randomised; Observational; Design type: Case-controlled study
Primary study design
Observational
Secondary study design
Case-control study
Trial setting
GP practices
Trial type
Diagnostic
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Topic: Renal and Urogenital; Subtopic: Renal and Urogenital (all Subtopics); Disease: Renal
Intervention
Patients will be identified through routine blood tests to measure kidney function collected during their hospital stay. They will be invited to participate in the study at least two months after these blood tests, by which time they will have recovered from their hospital stay. We will collect three routine blood and urine samples to measure kidney function: the first at recruitment (three months after the episode of AKI to assess the degree of recovery of renal function); the second at nine months (1 year after the AKI) and the third at 33 months (three years after the AKI). These samples can be collected in the community at patients GP surgery or local blood-taking clinic. We will retain samples for further testing. We will confirm medical details of patients from hospital records and we will monitor health status (including cause of death for any patients who die) through the records kept at the NHS Information Centre.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
Current primary outcome measures as of 28/03/2017:
Mortality, progression to a combined renal end point (initiation of RRT, GFR<15ml/min/1.73m2, doubling of serum creatinine) at one, three, five and ten years.
Previous primary outcome measures:
CKD progression; Timepoint(s): 1 year and 3 years
Secondary outcome measures
Current secondary outcome measures as of 28/03/2017:
CKD progession defined as ≥25% decline in eGFR plus decline in eGFR stage measred at one, three and five years.
Previous secondary outcome measures:
Mortality; Timepoint(s): 1, 3 and 5 years
Overall trial start date
25/03/2013
Overall trial end date
14/04/2026
Reason abandoned
Eligibility
Participant inclusion criteria
1. Age 18-85 years
2. Recent inpatient at Royal Derby Hospital during which a blood test was sent to assess kidney function, and was classified either as AKI or as NAKI (screened for possible AKI but who did not sustain AKI)
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Planned Sample Size: 1084; UK Sample Size: 1084
Participant exclusion criteria
1. Inability/refusal to give informed consent to participate
2. Language barrier that prevents informed postal consent
3. Death during the same hospital admission that AKI occurred
4. Receiving palliative care
Recruitment start date
23/04/2013
Recruitment end date
14/04/2016
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Royal Derby Hospital
Uttoxeter Road
Derby
DE22 3NE
United Kingdom
Funders
Funder type
Research organisation
Funder name
The Bupa Foundation (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
British Renal Society
Alternative name(s)
BRS
Funding Body Type
private sector organisation
Funding Body Subtype
professional associations and societies
Location
United Kingdom
Funder name
Kidney Research UK
Alternative name(s)
Funding Body Type
private sector organisation
Funding Body Subtype
other non-profit
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Planned publication in a high-impact peer reviewed journal. Patient feedback meetings to be held in May and June 2017 to update participants on the progress of the study.
IPD sharing plan:
The datasets generated during and/or analysed during the current study are/will be available upon request from Dr Nicholas Selby at Nicholas.Selby@notthingham.ac.uk
Intention to publish date
14/04/2027
Participant level data
Available on request
Results - basic reporting
Publication summary