Acute Kidney InjuryNCT02675296
Regional and Long Term Outcomes of Acute Kidney Injury in England From 2000 to 2015 - A National Database Study
An observational study of Acute Kidney Injury, run by University Hospitals of Derby and Burton NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
Acute kidney injury requiring dialysis (AKI-D) has increased considerably over last 15 years. The national rise in incidence of acute kidney injury has several ramifications in terms of cost to the health services resulting not only from cost of therapy but also from the later consequences of AKI from development of… Read more about this study
- Who is it for?
- Ages Up to 120 years
- Conditions the study is for
- Acute Kidney Injury
- How many people
- 54,680 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2015to Dec 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 120 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The 2000 to 2015 data was extracted from the Hospital Episode Statistics (HES), a data warehouse containing details of all admissions, outpatient appointments and A\&E attendances at NHS hospitals in England. HES collects a detailed record for each 'episode' of admitted patient care delivered in England, either by NHS hospitals, primary care trusts, mental health trusts or delivered in the independent sector but commissioned by the NHS. These data are collected during a patient's time in hospital and stored as a large collection of separate records, one for each period of care, in a secure data warehouse.
Who may be able to join
- Patients with AKI as identified by International classification of disease, 10th revision (ICD10) of N17 any of the diagnoses codes.
- AKI patients with procedure code for hemodialysis or for hemofiltration in any of the 25 procedures codes.
Who cannot join
- AKI patients who had CKD stage 5 and end stage renal disease
- AKI patients with procedure codes for arteriovenous fistula or arteriovenous shunt during the inpatient admission.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Derby Hospital NHS Foundation Trust
Derby, Derbyshire, DE22 3NE
About this study
Acute kidney injury requiring dialysis (AKI-D) has increased considerably over last 15 years. The national rise in incidence of acute kidney injury has several ramifications in terms of cost to the health services resulting not only from cost of therapy but also from the later consequences of AKI from development of chronic kidney disease and cardiovascular disease. Mortality in patients with AKI-D is very high and remains unchanged in the last decade in England. In recent years it is becoming clearer that even the national incidence and case-fatality of AKI is influenced by regional variation. In last three decades, many studies have reported unwarranted variation in a wide range of procedures, from the performance of cesarean section and coronary angiography to the treatment of early prostate cancer, stroke, and the ailments of the chronically ill. In surgical care there is evidence that the variation may be driven by forces other than patient illness and medical appropriateness such as access to care and other socioeconomic factors, provider capacity of the local system, medical malpractice pressure, and distinctly different local practices. Despite the public health burden of AKI-D in England, it is unclear if regional variation exists in AKI-D. Variation in incidence of AKI-D in different region of a country may be influenced by patient and physician demographics of the regions, physician preferences or the nature of the hospital serving the population. To reduce the incidence and case fatality of AKI-D, it is imperative to understand if variations in incidence and case-fatality in AKI-D exists in different regions of the country.
To address this gap in knowledge, the investigators combined national database of hospital admissions and discharge with census data from office of national statistic over a period of fifteen years to determine the trend in change in the regional incidence and case fatality of AKI requiring dialysis in England. The investigators also explored various determinants of the regional variation in the dialysis requiring AKI.
Read more
Methods Data source The investigators extracted 2000-2015 data from the Hospital Episode Statistics (HES), a data warehouse containing details of all admissions, outpatient appointments, and A\&E attendances at National Health Service (NHS) hospitals in England.
Definitions The investigators identified all cases of AKI by using validated International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM) codes in any diagnoses codes, in keeping with the objective of the study. Patients with any of the following codes were included: N17.0 for acute renal failure (ARF) with tubular necrosis, N17.1 for ARF with acute cortical necrosis, N17.2 for ARF with medullary necrosis, N17.8 for other ARF and N17.9 for ARF, unspecified. ARF has been replaced by new terminology, AKI, but due to lack of ICD10 codes for AKI, the investigators used the ICD10 codes for ARF and henceforth, will be referred to as AKI in this study. The investigators also extracted all available secondary diagnosis and up to 24 Office of Population Censuses and Surveys Classification of Interventions and Procedures, 4th revision (OPCS-4) codes. To identify patients with AKI-D, the investigators included OPCS code of X40.3 for hemodialysis or X40.4 for hemofiltration in any of the 25 procedures. Patients with chronic kidney disease stage 5 (CKD-5) starting chronic dialysis and end stage renal disease (ESRD) with ICD-10 code of N18.5 and N18.6 respectively were excluded. The investigators also excluded OPCS-4 codes for Arteriovenous fistula (L74.2) or Arteriovenous graft (L74.3) during the inpatient admission. HES data stratifies patient location into 16 different regions. The geographic regions in England were stratified as per the Office of National Statistic (ONS) into nine regions: North East, North West, Yorkshire and Humber, East Midlands, West Midlands, East of England, London, South East and South West. Patients' in geographical locations outside these nine regions were excluded. Patients who were admitted, but were not discharged during the study period will not be included in the study. The investigators also obtained completed hospital discharges from each region to estimate the effect of hospitalization on AKI-D incidence rates, along with number of nephrology consultants in each region from 2000 to 2015 from Health and Social Care Information Centre (HSCIC) in the annual census of medical and dental staff in the NHS. The investigators will also obtain linkage with ONS and UK Renal Registry (UKRR) for long-term patient and renal outcomes. To obtain population incidence of AKI-D for each region, mid-year population of the region in each year from 2000 to 2015 was obtained from the ONS.
- Conditions
- Acute Kidney Injury
- Keywords
- outcome
- Medical subject headings
- Acute Kidney Injury
What is being measured
The primary outcome is the main question the study is designed to answer.
Incident of AKI-D patients
The study aims to identify regional variation in incidence of AKI-D in each region of England over 15 year period
Measured: 15 years
Secondary outcomes (3)
Number of deaths in each region.
Patient survival over 10 year period
Measured: 10 years
Number of patients developing end stage renal disease
Renal survival over 10 year period
Measured: 10 years
Case-fatality in AKI-D patients
The study aims to identify regional variation in case-fatality of AKI-D in each region of England over 15 year period
Measured: 15 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2016 (estimated)
- Study startSep 2015
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 54,680 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospitals of Derby and Burton NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Nitin Kolhe, University Hospitals of Derby and Burton NHS Foundation Trust
- Investigators
- Nitin V Kolhe, MD, Principal investigator, Derby Teaching Hospital NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02675296
- Sponsor's protocol ID
- 1.3
- Status last verified
- Feb 2016
- First submitted
- 28 Jan 2016
- Last updated
- 5 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Data is freely available from HSCIC
Publications
Kolhe NV, Muirhead AW, Wilkes SR, Fluck RJ, Taal MW. National trends in acute kidney injury requiring dialysis in England between 1998 and 2013. Kidney Int. 2015 Nov;88(5):1161-9. doi: 10.1038/ki.2015.234. Epub 2015 Jul 29.
PubMed 26221750Hsu RK, McCulloch CE, Heung M, Saran R, Shahinian VB, Pavkov ME, Burrows NR, Powe NR, Hsu CY; Centers for Disease Control and Prevention Chronic Kidney Disease Surveillance Team. Exploring Potential Reasons for the Temporal Trend in Dialysis-Requiring AKI in the United States. Clin J Am Soc Nephrol. 2016 Jan 7;11(1):14-20. doi: 10.2215/CJN.04520415. Epub 2015 Dec 18.
PubMed 26683890Hsu RK, McCulloch CE, Ku E, Dudley RA, Hsu CY. Regional variation in the incidence of dialysis-requiring AKI in the United States. Clin J Am Soc Nephrol. 2013 Sep;8(9):1476-81. doi: 10.2215/CJN.12611212. Epub 2013 Aug 8.
PubMed 23929923Wald R, McArthur E, Adhikari NK, Bagshaw SM, Burns KE, Garg AX, Harel Z, Kitchlu A, Mazer CD, Nash DM, Scales DC, Silver SA, Ray JG, Friedrich JO. Changing incidence and outcomes following dialysis-requiring acute kidney injury among critically ill adults: a population-based cohort study. Am J Kidney Dis. 2015 Jun;65(6):870-7. doi: 10.1053/j.ajkd.2014.10.017. Epub 2014 Dec 18.
PubMed 25533599
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Regional and Long Term Outcomes of Acute Kidney Injury in England From 2000 to 2015 - A National Database Study
- ClinicalTrials.gov ID
- NCT02675296
- Acronym / sponsor ID
- 1.3
- Conditions
- Acute Kidney Injury
- Keywords
- outcome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 54,680 participants (actual)
- Lead sponsor
- University Hospitals of Derby and Burton NHS Foundation TrustUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 5 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Acute kidney injury requiring dialysis (AKI-D) has increased considerably over last 15 years. The national rise in incidence of acute kidney injury has several ramifications in terms of cost to the health services resulting not only from cost of therapy but also from the later consequences of AKI from development of chronic kidney disease and cardiovascular disease. Mortality in patients with AKI-D is very high and remains unchanged in the last decade in England. In recent years it is becoming clearer that even the national incidence and case-fatality of AKI is influenced by regional variation. In last three decades, many studies have reported unwarranted variation in a wide range of procedures, from the performance of cesarean section and coronary angiography to the treatment of early prostate cancer, stroke, and the ailments of the chronically ill. In surgical care there is evidence that the variation may be driven by forces other than patient illness and medical appropriateness such as access to care and other socioeconomic factors, provider capacity of the local system, medical malpractice pressure, and distinctly different local practices. Despite the public health burden of AKI-D in England, it is unclear if regional variation exists in AKI-D. Variation in incidence of AKI-D in different region of a country may be influenced by patient and physician demographics of the regions, physician preferences or the nature of the hospital serving the population. To reduce the incidence and case fatality of AKI-D, it is imperative to understand if variations in incidence and case-fatality in AKI-D exists in different regions of the country.
To address this gap in knowledge, the investigators combined national database of hospital admissions and discharge with census data from office of national statistic over a period of fifteen years to determine the trend in change in the regional incidence and case fatality of AKI requiring dialysis in England. The investigators also explored various determinants of the regional variation in the dialysis requiring AKI.
Methods Data source The investigators extracted 2000-2015 data from the Hospital Episode Statistics (HES), a data warehouse containing details of all admissions, outpatient appointments, and A\&E attendances at National Health Service (NHS) hospitals in England.
Definitions The investigators identified all cases of AKI by using validated International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM) codes in any diagnoses codes, in keeping with the objective of the study. Patients with any of the following codes were included: N17.0 for acute renal failure (ARF) with tubular necrosis, N17.1 for ARF with acute cortical necrosis, N17.2 for ARF with medullary necrosis, N17.8 for other ARF and N17.9 for ARF, unspecified. ARF has been replaced by new terminology, AKI, but due to lack of ICD10 codes for AKI, the investigators used the ICD10 codes for ARF and henceforth, will be referred to as AKI in this study. The investigators also extracted all available secondary diagnosis and up to 24 Office of Population Censuses and Surveys Classification of Interventions and Procedures, 4th revision (OPCS-4) codes. To identify patients with AKI-D, the investigators included OPCS code of X40.3 for hemodialysis or X40.4 for hemofiltration in any of the 25 procedures. Patients with chronic kidney disease stage 5 (CKD-5) starting chronic dialysis and end stage renal disease (ESRD) with ICD-10 code of N18.5 and N18.6 respectively were excluded. The investigators also excluded OPCS-4 codes for Arteriovenous fistula (L74.2) or Arteriovenous graft (L74.3) during the inpatient admission. HES data stratifies patient location into 16 different regions. The geographic regions in England were stratified as per the Office of National Statistic (ONS) into nine regions: North East, North West, Yorkshire and Humber, East Midlands, West Midlands, East of England, London, South East and South West. Patients' in geographical locations outside these nine regions were excluded. Patients who were admitted, but were not discharged during the study period will not be included in the study. The investigators also obtained completed hospital discharges from each region to estimate the effect of hospitalization on AKI-D incidence rates, along with number of nephrology consultants in each region from 2000 to 2015 from Health and Social Care Information Centre (HSCIC) in the annual census of medical and dental staff in the NHS. The investigators will also obtain linkage with ONS and UK Renal Registry (UKRR) for long-term patient and renal outcomes. To obtain population incidence of AKI-D for each region, mid-year population of the region in each year from 2000 to 2015 was obtained from the ONS.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- Up to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The 2000 to 2015 data was extracted from the Hospital Episode Statistics (HES), a data warehouse containing details of all admissions, outpatient appointments and A\&E attendances at NHS hospitals in England. HES collects a detailed record for each 'episode' of admitted patient care delivered in England, either by NHS hospitals, primary care trusts, mental health trusts or delivered in the independent sector but commissioned by the NHS. These data are collected during a patient's time in hospital and stored as a large collection of separate records, one for each period of care, in a secure data warehouse.
Key inclusion criteria (2 listed)
- Patients with AKI as identified by International classification of disease, 10th revision (ICD10) of N17 any of the diagnoses codes.
- AKI patients with procedure code for hemodialysis or for hemofiltration in any of the 25 procedures codes.
Key exclusion criteria (2 listed)
- AKI patients who had CKD stage 5 and end stage renal disease
- AKI patients with procedure codes for arteriovenous fistula or arteriovenous shunt during the inpatient admission.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incident of AKI-D patients
Time frame: 15 years
The study aims to identify regional variation in incidence of AKI-D in each region of England over 15 year period
3 secondary outcomes
Number of deaths in each region.
Time frame: 10 years
Number of patients developing end stage renal disease
Time frame: 10 years
Case-fatality in AKI-D patients
Time frame: 15 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2016.
- Background: PubMed 26221750Kolhe NV, Muirhead AW, Wilkes SR, Fluck RJ, Taal MW. National trends in acute kidney injury requiring dialysis in England between 1998 and 2013. Kidney Int. 2015 Nov;88(5):1161-9. doi: 10.1038/ki.2015.234. Epub 2015 Jul 29.
- Background: PubMed 26683890Hsu RK, McCulloch CE, Heung M, Saran R, Shahinian VB, Pavkov ME, Burrows NR, Powe NR, Hsu CY; Centers for Disease Control and Prevention Chronic Kidney Disease Surveillance Team. Exploring Potential Reasons for the Temporal Trend in Dialysis-Requiring AKI in the United States. Clin J Am Soc Nephrol. 2016 Jan 7;11(1):14-20. doi: 10.2215/CJN.04520415. Epub 2015 Dec 18.
- Background: PubMed 23929923Hsu RK, McCulloch CE, Ku E, Dudley RA, Hsu CY. Regional variation in the incidence of dialysis-requiring AKI in the United States. Clin J Am Soc Nephrol. 2013 Sep;8(9):1476-81. doi: 10.2215/CJN.12611212. Epub 2013 Aug 8.
- Background: PubMed 25533599Wald R, McArthur E, Adhikari NK, Bagshaw SM, Burns KE, Garg AX, Harel Z, Kitchlu A, Mazer CD, Nash DM, Scales DC, Silver SA, Ray JG, Friedrich JO. Changing incidence and outcomes following dialysis-requiring acute kidney injury among critically ill adults: a population-based cohort study. Am J Kidney Dis. 2015 Jun;65(6):870-7. doi: 10.1053/j.ajkd.2014.10.017. Epub 2014 Dec 18.
- Individual participant dataSharing planned: Yes. Data is freely available from HSCIC
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nitin V Kolhe, MD principal investigator
Derby Teaching Hospital NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Kidney Injury, run by University Hospitals of Derby and Burton NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incident of AKI-D patients (time frame: 15 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02675296, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2016.