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Acute Kidney InjuryNCT02534584

Use of Care Bundle in Acute Kidney Injury

An observational study of Acute Kidney Injury, run by University Hospitals of Derby and Burton NHS Foundation Trust at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 17 years and older
Conditions the study is for
Acute Kidney Injury
How many people
944 participants
Where
1 siteUnited Kingdom
Study dates
Aug 2013to Jul 2015
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 17 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: All adults patients with acute kidney injury

Who may be able to join

  • All episodes of acute kidney injury in adults patients

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site
  • Derby Hospital NHS Foundation Trust

    Derby, Derbyshire, DE22 3NE

Other trials in United Kingdom

About this study

Official title: Impact of Compliance With a Care Bundle on Acute Kidney Injury Outcomes

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.

Read the detailed description

This single centre study will be conducted at the Royal Derby Hospital, a 1139-bed tertiary care centre. Data will be collected from February 2013 to December 2013 on all adult patients over the age of 18 years. An electronic recognition system for AKI has been in use since 2010 that allows prospective data collection for all cases of AKI. The electronic recognition system was modified in December 2012, to incorporate the Kidney Diseases Improving Global Outcomes (KDIGO) definitions for AKI. In an effort to improve the clinical outcomes, intranet guidelines were introduced along with the electronic recognition and alerting system. In December 2012, a one-page paper version of the AKI CB was devised, which was subsequently incorporated into the hospital electronic patient record on 1st February 2013. During this period, education on the AKI CB was given to all staff in acute areas of the hospital and a poster explaining the AKI CB was displayed in all clinical areas. The hospital already has electronic ordering of investigations and prescribing of medications in place. The CB consists of simple standardized investigations and interventions, reminding clinicians of the importance of thorough Assessment, Urinalysis, establishing a Diagnosis, planning Investigations and Treatment and at the same time issuing guidance about Seeking advice from nephrologist while caring for patients with AKI (AUDITS). All the steps in the CB are objective and the clinicians are requested to click yes or no for each step of the CB. On 1st August 2013, the AKI CB was coupled with an interruptive electronic alert, which was triggered by the first attempt to order blood tests or medications on patients who had been identified as having AKI. The interruptive alert would warn the clinician about AKI and request them to complete the AKI CB. Once the AKI CB was completed, the clinician was able to request blood tests or medication. The clinician would be able to override the alert only after stating the reason. The location of patients was categorized into the following divisions - Medical Assessment Unit, Medical wards, Surgical \& Orthopedic wards, Haematology and Oncology wards, Intensive Care and Surgical Step Down (high dependency unit) and Other wards.

A weekly report is automatically generated which captures patient location in the hospital, age, date of admission, date of discharge, finished consultant episode and survival status at the reporting date.

For this study, the investigators will analyze all AKI episodes, which had the AKI CB completed early (defined as within 24 hours of availability of the blood results) with those who either had AKI CB completed late (defined as after 24 hours of availability of the blood results) or not completed at all. The AKI episodes who either had AKI CB completed late or not completed will be considered as not having AKI CB completed for this analysis. Community acquired AKI will be defined as AKI within 24 hours of admission. Survival status of all patients will be obtained in February 2015.

Keywords
acute kidney injury, outcome, mortality, care-bundle
Medical subject headings
Acute Kidney Injury

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mortality

    This is the average follow up

    Measured: 1 year

Secondary outcomes (2)
  1. Length of stay

    This is average length of stay

    Measured: 10 days

  2. Severity of AKI as measured by AKI stages

    Proportion of patients whose AKI increases in severity, from AKI stage 1 to stage 2 and from stage 2 to stage 3

    Measured: 10 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Aug 2015 (estimated)
  2. Study startAug 2013
  3. Primary completionJan 2015
  4. Study completionJul 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
944 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02534584
Sponsor's protocol ID
1.0
Status last verified
Aug 2015
First submitted
23 Aug 2015
Last updated
27 Aug 2015
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

An observational study of Acute Kidney Injury, run by University Hospitals of Derby and Burton NHS Foundation Trust at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mortality (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2015.

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