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.
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
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.
- Conditions
- Acute Kidney Injury
- 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.
Mortality
This is the average follow up
Measured: 1 year
Secondary outcomes (2)
Length of stay
This is average length of stay
Measured: 10 days
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.
- First posted27 Aug 2015 (estimated)
- Study startAug 2013
- Primary completionJan 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University Hospitals of Derby and Burton NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Nitin Kolhe, University Hospitals of Derby and Burton NHS Foundation Trust
- Investigators
- Nitin V Kolhe, MD, DM, Principal investigator, Derby Teaching Hospital NHS Trust
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
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Compliance With a Care Bundle on Acute Kidney Injury Outcomes
- ClinicalTrials.gov ID
- NCT02534584
- Acronym / sponsor ID
- 1.0
- Conditions
- Acute Kidney Injury
- Keywords
- acute kidney injury, outcome, mortality, care-bundle
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 944 participants (actual)
- Lead sponsor
- University Hospitals of Derby and Burton NHS Foundation TrustUniversity, hospital or other
- Study start
- Aug 2013
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 27 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 17 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All adults patients with acute kidney injury
Key inclusion criteria (1 listed)
- All episodes of acute kidney injury in adults patients
Key exclusion criteria (2 listed)
- Age less than 17 years
- Patients without acute kidney injury
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Mortality
Time frame: 1 year
This is the average follow up
2 secondary outcomes
Length of stay
Time frame: 10 days
Severity of AKI as measured by AKI stages
Time frame: 10 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nitin V Kolhe, MD, DM principal investigator
Derby Teaching Hospital NHS Trust
1 site in 1 country: see every site and its status.
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.