- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02947698
Effect of Weekend Admission on Mortality Associated With Severe Acute Kidney Injury in England: a Propensity Score Matched, Population-based Study
Study Overview
Status
Conditions
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 Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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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
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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
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
in-hospital mortality for weekend and weekday AKI-D admissions
Time Frame: 60-day
|
60-day
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Effect of in-center nephrology services on weekdays and weekend mortality of AKI-D admissions
Time Frame: 60-day
|
60-day
|
|
Effect of deprivation on weekdays and weekend mortality of AKI-D admissions
Time Frame: 60-day
|
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
|
60-day
|
Collaborators and Investigators
Investigators
- Principal Investigator: Nitin V Kolhe, MD, Derby Hospital NHS Foundation Trust
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1.4
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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