NCT02534584

Brief Summary

This study is a service evaluation to assess the impact of compliance of Acute Kidney Injury care bundle (AKI-CB) on clinical and renal outcomes. The AKI care bundle is coupled with an interruptive electronic alert, which is triggered by the first attempt to order blood tests or medications on patients who have been identified as having AKI by the electronic recognition from serum creatinine results. The interruptive alert will warn the clinician about AKI and request them to complete the AKI care bundle. Once the AKI care bundle is completed, the clinician is able to request blood tests or medication. The clinician will be able to override the alert only after stating the reason. Education with respect to importance of AKI and the AKI-CB is provided every four months when junior doctors rotated through different specialities and also at clinical governance days. The investigators will compare AKI episodes, which have the AKI-CB completed early (defined as within 24 hours of availability of the blood results) with those who either had the AKI-CB completed late (defined as after 24 hours of availability of the blood results) or not completed at all. The AKI patients who either had the AKI-CB completed late or not completed will be considered as not having the AKI-CB completed for this analysis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
944

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2013

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2013

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 23, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 27, 2015

Completed
Last Updated

August 27, 2015

Status Verified

August 1, 2015

Enrollment Period

1.4 years

First QC Date

August 23, 2015

Last Update Submit

August 25, 2015

Conditions

Keywords

acute kidney injuryoutcomemortalitycare-bundle

Outcome Measures

Primary Outcomes (1)

  • Mortality

    This is the average follow up

    1 year

Secondary Outcomes (2)

  • Length of stay

    10 days

  • Severity of AKI as measured by AKI stages

    10 days

Eligibility Criteria

Age17 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All adults patients with acute kidney injury

You may qualify if:

  • All episodes of acute kidney injury in adults patients

You may not qualify if:

  • Age less than 17 years
  • Patients without acute kidney injury

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

Study Officials

  • Nitin V Kolhe, MD, DM

    Derby Teaching Hospital NHS Trust

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

August 23, 2015

First Posted

August 27, 2015

Study Start

August 1, 2013

Primary Completion

January 1, 2015

Study Completion

July 1, 2015

Last Updated

August 27, 2015

Record last verified: 2015-08

Locations