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Epidemiology of Acute Kidney Injury in England - 1998 to 2013

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ClinicalTrials.gov Identifier: NCT02216695
Recruitment Status : Completed
First Posted : August 15, 2014
Results First Posted : December 9, 2016
Last Update Posted : December 9, 2016
Sponsor:
Information provided by (Responsible Party):
Dr. Nitin Kolhe, University Hospitals of Derby and Burton NHS Foundation Trust

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

Condition or disease
Acute Kidney Injury

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Study Type : Observational
Actual Enrollment : 64882 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Epidemiology of Acute Kidney Injury in England - 1998 to 2013
Study Start Date : October 2014
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014



Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.



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Ages Eligible for Study:   up to 120 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
This is a historical cohort study using already collected data 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.
Criteria

Inclusion Criteria:

  1. Patients with any of the following ICD 10 codes, in any of the diagnoses, in the HES database, 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.
  2. All patients of any age and gender, with AKI as identified as above between the period of 1st April 1998 and 31st March 2013.

Exclusion Criteria:

  1. Patients with any of the following codes in any of the diagnoses codes will be excluded: N18.5 for chronic kidney disease stage 5, N18.6 for end stage renal disease.
  2. Patients with following codes in the any of the procedure codes will be excluded: L74.2 for arterio-venous fistula, L74.3 for arterio-venous graft.
  3. Patients', who were admitted in the study period, but were not discharged, will be excluded.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02216695


Locations
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United Kingdom
Derby Hospital NHS Foundation Trust
Derby, Derbyshire, United Kingdom, DE22 3NE
Sponsors and Collaborators
University Hospitals of Derby and Burton NHS Foundation Trust
Investigators
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Principal Investigator: Nitin V Kolhe, MD, DM Derby Hospital NHS Trust
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Responsible Party: Dr. Nitin Kolhe, Consultant Nephrologist, University Hospitals of Derby and Burton NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT02216695    
Other Study ID Numbers: 1.2
First Posted: August 15, 2014    Key Record Dates
Results First Posted: December 9, 2016
Last Update Posted: December 9, 2016
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: The data is freely available from www.hscic.gov.uk
Keywords provided by Dr. Nitin Kolhe, University Hospitals of Derby and Burton NHS Foundation Trust:
acute kidney injury
epidemiology
mortality
Additional relevant MeSH terms:
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Acute Kidney Injury
Wounds and Injuries
Renal Insufficiency
Kidney Diseases
Urologic Diseases