NCT02216695

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64,882

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2014

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 8, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 15, 2014

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2014

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
2 years until next milestone

Results Posted

Study results publicly available

December 9, 2016

Completed
Last Updated

December 9, 2016

Status Verified

December 1, 2016

Enrollment Period

2 months

First QC Date

August 8, 2014

Results QC Date

August 8, 2016

Last Update Submit

December 8, 2016

Conditions

Keywords

acute kidney injuryepidemiologymortality

Outcome Measures

Primary Outcomes (2)

  • Secular Trends in the Mortality After Acute Kidney Injury From 1998 to 2013

    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.

    Participants will be followed for the duration of hospital stay (average of 15 days)

  • Incidence of AKI-D From 1998-9 to 2012-13

    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.

    15-years

Secondary Outcomes (2)

  • Mortality From Acute Kidney Injury in Each Age Group From 1998 to 2013

    Participants will be followed for the duration of hospital stay (average 13 days)

  • Mortality From Acute Kidney Injury in Each Five-year Period From 1998 to 2013

    Participants will be followed for the duration of hospital stay (average 13 days)

Eligibility Criteria

Age1 Day - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.
  • All patients of any age and gender, with AKI as identified as above between the period of 1st April 1998 and 31st March 2013.

You may not qualify if:

  • 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.
  • 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.
  • Patients', who were admitted in the study period, but were not discharged, will be excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Derby Hospital NHS Foundation Trust

Derby, Derbyshire, DE22 3NE, United Kingdom

Location

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Results Point of Contact

Title
Nitin V Kolhe
Organization
Derby Teaching Hospital NHS Trust

Study Officials

  • Nitin V Kolhe, MD, DM

    Derby Hospital NHS Trust

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant Nephrologist

Study Record Dates

First Submitted

August 8, 2014

First Posted

August 15, 2014

Study Start

October 1, 2014

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

December 9, 2016

Results First Posted

December 9, 2016

Record last verified: 2016-12

Data Sharing

IPD Sharing
Will not share

The data is freely available from www.hscic.gov.uk

Locations