NCT02947698

Brief Summary

Increased in-hospital mortality associated with weekend admission has been reported for many acute conditions, but no study has investigated "weekend effect" for acute kidney injury requiring dialysis (AKI-D). In this study, the investigators compared mortality in AKI-D patients admitted on weekday versus weekend and assessed factors associated with increased mortality.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
53,878

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2016

Shorter than P25 for all trials

Status
completed

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

Study Start

First participant enrolled

January 1, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

October 26, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 28, 2016

Completed
Last Updated

October 28, 2016

Status Verified

October 1, 2016

Enrollment Period

3 months

First QC Date

October 26, 2016

Last Update Submit

October 27, 2016

Conditions

Keywords

acute kidney injuryweekend admissionmortality

Outcome Measures

Primary Outcomes (1)

  • in-hospital mortality for weekend and weekday AKI-D admissions

    60-day

Secondary Outcomes (2)

  • Effect of in-center nephrology services on weekdays and weekend mortality of AKI-D admissions

    60-day

  • Effect of deprivation on weekdays and weekend mortality of AKI-D admissions

    60-day

Study Arms (2)

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

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

Eligibility Criteria

AgeUp to 120 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

2003-2015 data from the Hospital Episode Statistics (HES) database containing details of all admissions at National Health Service (NHS) hospitals in England will be used to extract all AKI-D patients

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

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

Study Officials

  • Nitin V Kolhe, MD

    Derby Hospital NHS Foundation Trust

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

October 26, 2016

First Posted

October 28, 2016

Study Start

January 1, 2016

Primary Completion

April 1, 2016

Study Completion

April 1, 2016

Last Updated

October 28, 2016

Record last verified: 2016-10

Data Sharing

IPD Sharing
Will not share

The data is anonymised and freely available from HSCIC