Condition category
Urological and Genital Diseases
Date applied
15/01/2014
Date assigned
06/03/2014
Last edited
22/05/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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 patient’s 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?
The Bupa Foundation (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

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

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

CKD progression; Timepoint(s): 1 year and 3 years

Secondary outcome measures

Mortality; Timepoint(s): 1, 3 and 5 years

Overall trial start date

25/03/2013

Overall trial end date

25/03/2015

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

25/03/2013

Recruitment end date

25/03/2015

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Uttoxeter Road
Derby
DE22 3NE
United Kingdom

Sponsor information

Organisation

Derby Hospital NHS Foundation Trust (UK)

Sponsor details

Research and Development Department
Derby City General Hospital
Uttoxeter Road
Derby
DE22 3DT
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Research organisation

Funder name

The Bupa Foundation (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes