NCT04579562

Brief Summary

The COVID-19 pandemic has exposed the unwanted variation in outcomes as evidence by Public Health England's report on increased mortality in regions of the country. For example, UHDB, in East Midlands, has reported a high crude mortality as compared to other Trusts in the region.8 There may also have been variation in the incidence of complications of COVID-19 in the form of AKI, which may have influenced mortality. Variation in outcomes may be because of various factors - differing population demographics, underlying health conditions in the population, deprivation, physician preference and knowledge and ethnic diversity. Unwanted variation is care that is not consistent with a patient's preference or related to \[their\] underlying illness. It is important to understand the reason for unwanted variation in outcomes associated with COVID-19 to minimise patient harm and reduce morbidity and mortality.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
5,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2020

Shorter than P25 for all trials

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 6, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 8, 2020

Completed
24 days until next milestone

Study Start

First participant enrolled

November 1, 2020

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2021

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2021

Completed
Last Updated

October 8, 2020

Status Verified

October 1, 2020

Enrollment Period

5 months

First QC Date

October 6, 2020

Last Update Submit

October 6, 2020

Conditions

Outcome Measures

Primary Outcomes (2)

  • All-cause mortality

    In-hospital all cause mortality in patients with acute kidney injury and COVID-19

    30 days

  • acute kidney injury

    Incidence of acute kidney injury in patients with COVID-19

    30 days

Secondary Outcomes (1)

  • Mechanical ventilation

    30 days

Study Arms (3)

COVID-19 positive AKI

Other: No intervention

COVID-19 positive no AKI

Other: No intervention

COVID negative AKI

Other: No intervention

Interventions

This is observational, non-interventional study

COVID negative AKICOVID-19 positive AKICOVID-19 positive no AKI

Eligibility Criteria

Age18 Years - 110 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

We will use analysis of all admitted patients in the past in England between 1st March 2020 and 30th June 2020 from the Hospital Episode Statistics (HES), a data warehouse containing details of all admissions at NHS hospitals in England. This design will help to analyse large number of AKI patients in short time-span so as to cascade the learning in timely fashion. HES collects a detailed record for each admitted patient care delivered in England, either by NHS hospitals. In each patient record, there are specific codes for additional diagnosis, or operations. We will extract all patients with diagnosis of COVID-19 by ICD-10 code of U07.1 and AKI as identified by ICD-10 code of N17 in any of the 20 diagnostic codes during the study period.

You may qualify if:

  • This study will have two work packages (WP). Work Package 1 (WP1): Regional epidemiology of COVID-19 in England All patients who are admitted to hospital with COVID-19 infection between 1st March 2020 and 30th June 2020 and who meet following criteria will be included
  • Diagnostic code for COVID-19 (U07.1) in any of the 20 diagnoses codes
  • Adult patients greater or equal to 18 years of age.
  • Work Package 2 (WP2): Epidemiology of COVID-19 associated AKI in England All patients who are admitted to hospital with acute kidney injury (AKI) between 1st March 2020 and 30th June 2020 and who meet following criteria will be included
  • Diagnostic code for AKI (N17) in any of the 20 diagnoses codes
  • Adult patients greater or equal to 18 years of age.

You may not qualify if:

  • WP1:
  • The following patients will be excluded from the study
  • Patients not admitted to the hospital
  • Paediatric patients \< 18 years of age
  • WP2:
  • The following patients will be excluded from the study
  • Patients not admitted to the hospital
  • Paediatric patients \< 18 years of age
  • Patients on chronic maintenance haemodialysis or peritoneal dialysis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Kolhe NV, Fluck R, Taal M. Effect of COVID-19 with or without acute kidney injury on inpatient mortality in England: a national observational study using administrative data. BMJ Open. 2025 Mar 15;15(3):e095020. doi: 10.1136/bmjopen-2024-095020.

  • Kolhe NV, Fluck RJ, Taal MW. Regional variation of COVID-19 admissions, acute kidney injury and mortality in England - a national observational study using administrative data. BMC Infect Dis. 2024 Mar 22;24(1):346. doi: 10.1186/s12879-024-09210-6.

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Nitin V Kolhe, DM

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 6, 2020

First Posted

October 8, 2020

Study Start

November 1, 2020

Primary Completion

March 31, 2021

Study Completion

October 31, 2021

Last Updated

October 8, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, SAP
Time Frame
6 months