Acute Kidney InjuryNCT02947698
Effect of Weekend Admission on Mortality Associated With Severe Acute Kidney Injury in England: a Propensity Score Matched, Population-based Study
An observational study of Acute Kidney Injury and Outcome, Fatal, run by University Hospitals of Derby and Burton NHS Foundation Trust.
Trial summary
Increased in-hospital mortality associated with weekend admission has been reported for many acute conditions, but no study has investigated "weekend effect" for acute kidney injury requiring dialysis (AKI-D). Read more about this study
- Who is it for?
- Ages Up to 120 years
- Conditions the study is for
- Acute Kidney Injury, Outcome, Fatal
- How many people
- 53,878 participants
- Where
- No sites listed yet
- Study dates
- Jan 2016to Apr 2016
- 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: 2003-2015 data from the Hospital Episode Statistics (HES) database containing details of all admissions at National Health Service (NHS) hospitals in England will be used to extract all AKI-D patients
Who may be able to join
- AKI cases identified by using validated International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM) codes of N17 in any diagnoses codes.
- AKI cases requiring dialysis (AKI-D) were identified by OPCS code of X40.3 for hemodialysis or X40.4 for hemofiltration in any of the 24 procedures.
Who cannot join
- Patients' with ICD10 codes N18.5 and N18.6 for chronic kidney disease stage five (CKD-5) and end stage renal disease (ESRD) respectively will be excluded.
- Patients with OPCS-4 codes for arteriovenous fistula (L74.2) or arteriovenous shunt (L74.3) during the inpatient admission will be excluded.
About this study
Increased in-hospital mortality associated with weekend admission has been reported for many acute conditions, but no study has investigated "weekend effect" for acute kidney injury requiring dialysis (AKI-D). In this study, the investigators compared mortality in AKI-D patients admitted on weekday versus weekend and assessed factors associated with increased mortality.
Read the detailed description
Several studies have reported an unwanted adverse effect of weekend admission on mortality in certain acute medical conditions. Though the reason for this variation could be illness severity, some studies have hypothesized that this could be due to variation in care provided over weekends when services are a minimum. The increased mortality over weekends for certain conditions in the National Health Service (NHS) in England has led to an intense debate on reconfiguring the health service. Little is known about the impact of the weekend effect on severe acute kidney requiring dialysis (AKI-D) in England, the incidence of which has increased more than 12-foldover the past 15 years. Most nephrology departments in England provide continuous consultant cover over weekends and have the capacity to perform emergency dialysis as needed over weekends suggesting that a weekend effect is less likely to occur. Patients admitted over the weekend may present in three ways - with severe AKI requiring dialysis over the weekend, with AKI and requiring dialysis on a subsequent weekday or with no AKI, but develop AKI-D during the in-patient stay over next few days. Some studies have reported that patients starting dialysis on Sunday or a diagnosis of severe AKI over weekend, does not affect mortality, while others have reported increased mortality for AKI in all sizes of hospital over weekend. One explanation for this observation is that necessary dialysis therapy may not be initiated on a weekend as a result of limitations in physician or nurse staffing or device availability. However, bias can be created by single center studies as it is well recognized that the epidemiology of AKI-D shows considerable regional variation and this may be true for all days of the week. It can also be speculated that patients admitted on weekends may not receive optimal care resulting in development of new AKI or progression of AKI to AKI-D resulting in excess mortality.
With this background, the investigators wanted to investigate whether a weekend effect on mortality exists for AKI-D patients in England. The investigators hypothesized that patients admitted over weekend would have increased mortality irrespective of demographic features and clinical characteristics. They also hypothesized that the effect on mortality would be more pronounced in centers with no on-site nephrology services.
- Conditions
- Acute Kidney Injury, Outcome, Fatal
- Keywords
- acute kidney injury, weekend admission, mortality
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Acute kidney injury patients admitted on weekday | All patients with acute kidney injury requiring dialysis admitted on week day (Monday to Friday) between 1st April 2003 and 31st March 2015 | |
| Acute kidney injury patients admitted on weekend | All patients with acute kidney injury requiring dialysis admitted on weekend (Saturday or Sunday) between 1st April 2003 and 31st March 2015 |
What is being measured
The primary outcome is the main question the study is designed to answer.
in-hospital mortality for weekend and weekday AKI-D admissions
Measured: 60-day
Secondary outcomes (2)
Effect of in-center nephrology services on weekdays and weekend mortality of AKI-D admissions
Measured: 60-day
Effect of deprivation on weekdays and weekend mortality of AKI-D admissions
The Index of Multiple Deprivation is the official measure of relative deprivation (for neighborhoods) in England. The Index of Multiple Deprivation ranks every small area in England from one (most deprived area) to 32,844 (least deprived area) and deciles are calculated dividing the ranking into 10 equal groups
Measured: 60-day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2016 (estimated)
- Study startJan 2016
- Primary completionApr 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 53,878 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 Hospital NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02947698
- Sponsor's protocol ID
- 1.4
- Status last verified
- Oct 2016
- First submitted
- 26 Oct 2016
- Last updated
- 28 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: The data is anonymised and freely available from HSCIC
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Weekend Admission on Mortality Associated With Severe Acute Kidney Injury in England: a Propensity Score Matched, Population-based Study
- ClinicalTrials.gov ID
- NCT02947698
- Acronym / sponsor ID
- 1.4
- Conditions
- Acute Kidney Injury, Outcome, Fatal
- Keywords
- acute kidney injury, weekend admission, mortality
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 53,878 participants (actual)
- Lead sponsor
- University Hospitals of Derby and Burton NHS Foundation TrustUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 28 Oct 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.
Increased in-hospital mortality associated with weekend admission has been reported for many acute conditions, but no study has investigated "weekend effect" for acute kidney injury requiring dialysis (AKI-D). In this study, the investigators compared mortality in AKI-D patients admitted on weekday versus weekend and assessed factors associated with increased mortality.
Detailed description
Several studies have reported an unwanted adverse effect of weekend admission on mortality in certain acute medical conditions. Though the reason for this variation could be illness severity, some studies have hypothesized that this could be due to variation in care provided over weekends when services are a minimum. The increased mortality over weekends for certain conditions in the National Health Service (NHS) in England has led to an intense debate on reconfiguring the health service. Little is known about the impact of the weekend effect on severe acute kidney requiring dialysis (AKI-D) in England, the incidence of which has increased more than 12-foldover the past 15 years. Most nephrology departments in England provide continuous consultant cover over weekends and have the capacity to perform emergency dialysis as needed over weekends suggesting that a weekend effect is less likely to occur. Patients admitted over the weekend may present in three ways - with severe AKI requiring dialysis over the weekend, with AKI and requiring dialysis on a subsequent weekday or with no AKI, but develop AKI-D during the in-patient stay over next few days. Some studies have reported that patients starting dialysis on Sunday or a diagnosis of severe AKI over weekend, does not affect mortality, while others have reported increased mortality for AKI in all sizes of hospital over weekend. One explanation for this observation is that necessary dialysis therapy may not be initiated on a weekend as a result of limitations in physician or nurse staffing or device availability. However, bias can be created by single center studies as it is well recognized that the epidemiology of AKI-D shows considerable regional variation and this may be true for all days of the week. It can also be speculated that patients admitted on weekends may not receive optimal care resulting in development of new AKI or progression of AKI to AKI-D resulting in excess mortality.
With this background, the investigators wanted to investigate whether a weekend effect on mortality exists for AKI-D patients in England. The investigators hypothesized that patients admitted over weekend would have increased mortality irrespective of demographic features and clinical characteristics. They also hypothesized that the effect on mortality would be more pronounced in centers with no on-site nephrology services.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acute kidney injury patients admitted on weekday | – | –All patients with acute kidney injury requiring dialysis admitted on week day (Monday to Friday) between 1st April 2003 and 31st March 2015 |
| Acute kidney injury patients admitted on weekend | – | –All patients with acute kidney injury requiring dialysis admitted on weekend (Saturday or Sunday) between 1st April 2003 and 31st March 2015 |
Who may qualify
- Ages
- Up to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 2003-2015 data from the Hospital Episode Statistics (HES) database containing details of all admissions at National Health Service (NHS) hospitals in England will be used to extract all AKI-D patients
Key inclusion criteria (2 listed)
- AKI cases identified by using validated International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM) codes of N17 in any diagnoses codes.
- AKI cases requiring dialysis (AKI-D) were identified by OPCS code of X40.3 for hemodialysis or X40.4 for hemofiltration in any of the 24 procedures.
Key exclusion criteria (2 listed)
- Patients' with ICD10 codes N18.5 and N18.6 for chronic kidney disease stage five (CKD-5) and end stage renal disease (ESRD) respectively will be excluded.
- Patients with OPCS-4 codes for arteriovenous fistula (L74.2) or arteriovenous shunt (L74.3) during the inpatient admission will be excluded.
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
in-hospital mortality for weekend and weekday AKI-D admissions
Time frame: 60-day
2 secondary outcomes
Effect of in-center nephrology services on weekdays and weekend mortality of AKI-D admissions
Time frame: 60-day
Effect of deprivation on weekdays and weekend mortality of AKI-D admissions
Time frame: 60-day
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 28 Oct 2016.
- Individual participant dataSharing planned: No. The data is anonymised and 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 Hospital NHS Foundation Trust
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Kidney Injury and Outcome, Fatal, run by University Hospitals of Derby and Burton NHS Foundation Trust.
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 28 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
in-hospital mortality for weekend and weekday AKI-D admissions (time frame: 60-day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Oct 2016.