Clinical Trial: Epidemiology of Acute Kidney Injury in England - 1998 to 2013

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: Epidemiology of Acute Kidney Injury in England - 1998 to 2013

Brief Summary: The true population incidence of acute kidney injury (AKI), previously called acute renal failure, in England is not known. A better understanding of the epidemiology of AKI at a national level is essential to inform initiatives to prevent AKI as well as reduce the associated morbidity and mortality. The purpose of this study is to combine the national database of all hospital discharges with national census data to investigate trends in the incidence of both, AKI not requiring dialysis and AKI requiring dialysis, as well as its associated mortality and its determinants in England between 1998 and 2013

Detailed Summary:

Subject Selection and Withdrawal We will identify all cases of AKI by using validated International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM) codes in any of he diagnoses codes, in keeping with the objective of the study. Patients with any of the following codes will be included: N17.0 for acute renal failure with tubular necrosis, N17.1 for acute renal failure with acute cortical necrosis, N17.2 for acute renal failure with medullary necrosis, N17.8 for other acute renal failure and N17.9 for acute renal failure, unspecified. Acute renal failure has been replaced by new terminology, acute kidney injury, but due to lack of ICD-10-CM codes for AKI, we will use the ICD-10-CM codes for acute renal failure and henceforth, will be referred to as AKI in this protocol.

Subject Recruitment and Screening We will extract 1998 to 2013 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. 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. We will extract secondary diagnosis codes for up to 14 diagnoses available till 2006-07 and up to 20 additional diagnoses from 2007 till 2013. In addition to demographic data, we will also extract up to 15 procedure codes. To identify AKI patients requiring dialysis, we will include procedure code of X40.3 for hemodialysis or X40.4 for hemofiltration in any of the 15 procedures. To exclude patients with chronic kidney
Sponsor: Derby Hospitals NHS Foundation Trust

Current Primary Outcome:

  • Secular Trends in the Mortality After Acute Kidney Injury From 1998 to 2013 [ Time Frame: Participants will be followed for the duration of hospital stay (average of 15 days) ]
    A retrospective cohort study of patients with acute kidney injury in England over a period of fifteen years, describing the trends in the mortality of acute kidney injury.
  • Incidence of AKI-D From 1998-9 to 2012-13 [ Time Frame: 15-years ]
    The population incidence of acute kidney injury requiring dialysis (AKI-D) was calculated using mid-year population of England in each year from 1998 to 2013 and expressed as people per million population. This was calculated by dividing number of cases by mid year population of England and multiplying by million.


Original Primary Outcome: Secular trends in the incidence and mortality after acute kidney injury from 1998 to 2013 [ Time Frame: Participants will be followed for the duration of hospital stay ]

A retrospective cohort study of patients with acute kidney injury in England over a period of fifteen years, describing the trends in the population incidence and mortality of acute kidney injury. The population trend in the incidence of acute kideny injury will be reported per year from 1998 to 2013


Current Secondary Outcome:

  • Mortality From Acute Kidney Injury in Each Age Group From 1998 to 2013 [ Time Frame: Participants will be followed for the duration of hospital stay (average 13 days) ]
    The secondary objective is evaluate factors affecting mortality due to acute kidney injury in the fifteen year period between 1998 and 2013.
  • Mortality From Acute Kidney Injury in Each Five-year Period From 1998 to 2013 [ Time Frame: Participants will be followed for the duration of hospital stay (average 13 days) ]
    The secondary objective is evaluate factors affecting mortality due to acute kidney injury in the fifteen year period between 1998 and 2013.


Original Secondary Outcome: To evaluate the determinants of mortality from acute kidney injury from 1998 to 2013 [ Time Frame: Participants will be followed for the duration of hospital stay ]

The secondary objective is evaluate factors affecting mortality due to acute kidney injury in the fifteen year period between 1998 and 2013.


Information By: Derby Hospitals NHS Foundation Trust

Dates:
Date Received: August 8, 2014
Date Started: October 2014
Date Completion:
Last Updated: December 8, 2016
Last Verified: December 2016