Condition category
Urological and Genital Diseases
Date applied
21/11/2013
Date assigned
05/02/2014
Last edited
05/02/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Studies, mainly from America, have suggested that patients whose kidneys do not work properly are more likely to be readmitted to hospital due to a long-term condition called chronic kidney disease. We are carrying out a study of patients admitted to hospitals in Birmingham (UK) to see if this is the case in the UK. We will also be looking at other factors such as age and race to see if these affect the results. These findings should help us improve the treatment that patients with chronic kidney disease get before and after being admitted to hospital.

Who can participate?
This study aims to recruit about 4000 adult men and women admitted to hospitals in Birmingham with and without chronic kidney disease.

What does the study involve?
Over a period of two years patients will be invited to participate in this study during an admission to hospital. At recruitment, participants will be asked a few lifestyle questions. They will then be followed up using existing electronic databases for a minimum of 2 years and a maximum of 4 years.

What are the possible benefits and risks of participating?
There will be no immediate direct benefit to those taking part but there should be benefits to future patients who are admitted to hospital so that we will be better able to understand reasons for readmission.

Where is the study run from?
The study is run from the University Hospital Birmingham (UK).

When is study starting and how long is it expected to run for?
It is anticipated that recruitment will start towards the end of 2013. Participants will be enrolled on the study for a period of two years.

Who is funding the study?
The National Institute for Health Research (NIHR), UK.

Who is the main contact?
Dr Charles Ferro
charles.ferro@uhb.nhs.uk

Trial website

Contact information

Type

Scientific

Primary contact

Dr Charles Ferro

ORCID ID

Contact details

Renal Unit
University Hospitals Birmingham NHS Foundation Trust
Edgbaston
Birmingham
B15 2WB
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

RRK4784

Study information

Scientific title

The Acute Care QUAliTy in chronIc Kidney disease study: an observational cohort study

Acronym

ACQUATIK

Study hypothesis

The principal objective is to identify whether a diagnosis of chronic kidney disease influences the treatment and long-term outcomes of patients admitted to hospital.This is the primary end-point of the study on which the sample size calculation is based.

Do UK patients classified with chronic kidney disease (CKD) by their GP have higher hospital re-admission rates than patients not classified with CKD?

More details can be found at: http://public.ukcrn.org.uk/search/StudyDetail.aspx?StudyID=15135

Ethics approval

NRES Committee West Midlands - South Birmingham, ref: 13/WM/0317

Study design

Observational cohort study

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

Hospitals

Trial type

Screening

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Chronic Kidney Disease

Intervention

This will be a multi-centre, observational, prospective, longitudinal study of approximately 4000 patients to be recruited over two years.

Two core centres in Birmingham (University Hospital Birmingham NHS Foundation Trust; Heart of England Foundation Trust), with a high number of acute admissions and serving a large ethnically diverse population are undertaking this observational study. Additional centres may join to help contribute to the recruitment of patients.

Patients will be approached by members of the clinical research after having been identified by a member of their clinical team. Where possible, an introduction will be made by a member of the clinical team responsible for the potential participants' care.

The patient will be given a verbal explanation of the study and given a written information sheet. They will be given sufficient time to ask questions and think about their potential participation. If necessary a member of the research team will return the following day if the potential participant wants more time to discuss their participation with family and friends.

Once they have given consent that will be the end of the participants' direct involvement in the research other than to receive updates of the study progress or if they wish to withdraw. At the time of consent a simple form will be filled in consisting of their NHS/Unit number and admission date. That information will then be passed on to the Department of Medical Informatics at the University Hospital Birmingham NHS Foundation Trust. Data held by the participants' general practitioner on their medication and chronic conditions will then be extracted and entered into a secure research database after having been pseudo-anonymised. This baseline data will then be linked via a unique identifier number to obtain detailed information on current and future hospital admissions as well as death from the Hospital Episode Statistics and the Office of National Statistics.

Patient enrolment period will be 2 years. Participants will be followed up for a minimum period of 2 years (last patient enrolled) and up to a maximum of 4 years (first patient enrolled).

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Do UK patients classified with chronic kidney disease by their GP have higher hospital re-admission rates than patients not classified with CKD

Secondary outcome measures

1. Do UK patients classified as having CKD by their GP have higher hospital re-admission rates for a cardiovascular disease event (i.e., hospitalization for acute myocardial infarction, angina, coronary artery bypass graft surgery, percutaneous coronary intervention, peripheral arterial disease, revascularization or stroke) than patients not classified with CKD
2. Do UK patients classified as having CKD by their GP have higher all-cause and cardiovascular mortality than patients not classified with CKD
3. Do UK patients classified as having CKD by their GP receive the same primary and secondary prevention treatments for cardiovascular disease as do patients not classified with CKD
4. Do UK patients classified as having CKD by their GP attain the same targets in the management of chronic diseases as defined by the QOF compared with patients not classified as having CKD
5. Do UK patients classified as having CKD by their GP receive the same treatment for cardiovascular disease when admitted to hospital with a cardiovascular event
6. Do UK patients classified with CKD by their GP derive the same benefit:risk ratio from primary and secondary prevention treatments for cardiovascular disease as do patients not classified with CKD
7. Do UK patients classified with CKD by their GP have a higher risk of further deterioration in renal function (acute kidney injury) than patients not classified with CKD
8. Are there a significant number of patients with biochemical evidence of CKD not classified as such by their GP

In addition, there will be a number of secondary analyses performed. All of the above research questions will be analysed separately to investigate the influence of age, ethnicity, SES, deprivation score, gender and concurrent co-morbidities on outcomes, treatment and classifications.

Overall trial start date

30/09/2013

Overall trial end date

01/10/2015

Reason abandoned

Eligibility

Participant inclusion criteria

1. Male and female aged 18 years or over
2. Patient from GP practices in the two main Clinical Commissioning Groups served by University Hospital Birmingham NHS Foundation Trust and Heart of England NHS Foundation Trust; i.e. Birmingham South and Central and Birmingham Cross City CCGs

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

4000

Participant exclusion criteria

1. Unable to give informed consent
2. Patient on dialysis or with a working kidney transplant
3. Patient already under long-term follow-up by renal team in secondary care

Recruitment start date

30/09/2013

Recruitment end date

01/10/2015

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Renal Unit
Birmingham
B15 2WB
United Kingdom

Sponsor information

Organisation

University Hospitals Birmingham NHS Foundation Trust (UK)

Sponsor details

Research and Development Department
Edgbaston
Birmingham
B15 2TH
United Kingdom

Sponsor type

Hospital/treatment centre

Website

http://www.uhb.nhs.uk/

Funders

Funder type

Government

Funder name

National Institute for Health Research (NIHR) (UK) - Post Doctoral Fellowship ref: NIHR-PDF-2012-05-205

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