Acute Kidney InjuryNCT03047382
Electronic Alerting Tool to Help Prevent Acute Kidney Injury
A study testing AKI Care Bundle in people with Acute Kidney Injury, run by Western Sussex Hospitals NHS Trust at 1 site in United Kingdom.
Trial summary
Around a third of patients who develop acute kidney injury (AKI) do so after a hospital admission (hospital-acquired - HA-AKI). The primary aim of the study is to prospectively test whether introducing a complex intervention (a 'care package' - comprising a clinical prediction rule incorporating an electronic alert… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Kidney Injury
- What is being tested?
- AKI Care Bundle
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30,298 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jul 2014to Oct 2016
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Admission as an emergency
- Spending at least one night as an in-patient
Who cannot join
- Patients under 18
- Patients not admitted as emergencies or staying less than one night in hospital.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Western Sussex Hospitals NHS Foundation Trust
Worthing, West Suusex
About this study
Official title: 'Preventable Acute Kidney Injury (AKI) Should Never Occur.' The Use of a Novel Electronic Prediction Alerting Tool to Deliver an Individualised Care Package for Hospital In-patients at Risk of AKI
Around a third of patients who develop acute kidney injury (AKI) do so after a hospital admission (hospital-acquired - HA-AKI).
The primary aim of the study is to prospectively test whether introducing a complex intervention (a 'care package' - comprising a clinical prediction rule incorporating an electronic alert which generates a checklist for patient management to relevant health professionals) can identify patients on admission to hospital who are at risk of developing HA-AKI, highlight the need for closer monitoring and allow putative preventative measures to be put in place.
The investigators will introduce the care package in one acute hospital and evaluate its effectiveness in reducing HA-AKI and its associated morbidity, over ten months, compared to a sister hospital within the same Trust (which will act as a control site). The investigators will extend evaluation for a further ten months to assess sustainability on the first site and introduce the package at the control hospital to assess generalisability. The primary aim is reducing HA-AKI, but secondary aims will include improved outcomes associated with HA-AKI, management of patients already with AKI on admission to hospital (whose care may also benefit from the checklist) and a cost-effectiveness analysis.
Read the detailed description
Acute Kidney Injury (AKI) is common in hospital (incidence of 10-20% - up to 70% in the critically ill), with high associated morbidity and mortality. Even small changes in renal function are associated with increased mortality. The 2009 National Confidential Enquiry into Patient Outcome and Death examined the care of patients who had died in hospital with a primary diagnosis of AKI. Over 40% of cases had an unacceptable delay in diagnosis and in 20% of cases, AKI was thought to be predictable and avoidable.
Electronic alerts have been studied for patients with established AKI, however, they have highlighted rises in creatinine after insult rather than identifying patients at risk of AKI - a third of hospital AKI cases occur after admission (HA-AKI). Risk factors have been reported in surgical and burns patients. However, strategies to identify patients admitted as medical emergencies at risk of developing AKI are lacking - the group accounting for most Intensive Care admissions with AKI.
The investigators multidisciplinary team, with significant experience utilising technology in healthcare, have developed a novel prediction score - Acute Kidney injury Prediction Score (APS). Utilising physiological measurements, biochemical parameters and known co-morbidities, the APS identifies patients at risk of developing HA-AKI following admission (1/3 of all AKI cases).
A 'care package' has been devised incorporating the APS into an automated electronic algorithm to send realtime alerts to staff on the Observation chart, e-mail the patient's Consultant and advise on a checklist. Alongside this, an E-learning AKI module for ward staff has been developed building on NICE Guidance with additional information regarding the APS.
Aims Primary: investigate whether introducing a 'care package' can reduce HA-AKI in patients admitted to hospital as an emergency.
Secondary include determining whether the intervention: reduces associated complications; improves outcomes in patients with AKI on admission; and is cost-effective.
Research Questions Primary: can a 'care package' by systematically recognising the 'at risk' patient, alerting and prompting management to staff educated in the problem, reduce HA-AKI?
Secondary:
- Can harms associated with AKI be reduced?
- Is the intervention acceptable to staff and are there barriers to implementation?
- Are improvements sustainable and can the intervention be successfully applied to a second hospital?
- Does the intervention improve outcomes of those with AKI on admission?
- Is the intervention cost-effective?
Design A prospective, non-randomised, parallel cohorts study, with before-after trial periods, at intervention and control hospital sites, will be performed. A run-in phase (10 months) for baseline data collection and prospective external validation is followed by the intervention on one site (Worthing) with the Chichester site acting as control (Phase 1) for 10 months. The intervention will then be introduced at Chichester whilst continuing at Worthing (Phase 2) for 10 months. The additional period will allow analysis of the interventions' impact on readmissions.
Potential benefits:
- Preventing morbidity and mortality including secondary complications such as chronic kidney disease (immediate and longer term).
- Reducing length of stay, thus reducing potential exposure to harm.
- Prevent requirement for renal replacement therapies and escalation to Intensive Care with associated morbidity, mortality and psychological harm.
- A Cost-effectiveness analysis will aim to demonstrate whether such a strategy could provide savings locally and to the wider health economy (short and long-term).
- Inform the healthcare community on applicability of information technology to benefit patients and improve staff engagement, with potential utilisation in a number of other conditions.
- Conditions
- Acute Kidney Injury
- Being tested
- AKI Care Bundle
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AKI Care BundleOther
Patients identified as high risk of AKI by the electronic clinical prediction model will be managed with a care bundle of best practice.
| Study group | Role | What they receive |
|---|---|---|
| Worthing Hospital site | Active comparator | AKI Care bundle instituted at Worthing site Receives: Other: AKI Care Bundle |
| Chichester Hospital site | No intervention | Continues standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospital Acquired AKI (HA-AKI) - KDIGO rise in serum creatinine
HA-AKI will be defined as per KDIGO change in serum creatinine i.e. a ≥26.4μmol/L increase within a 48 hour period (during the first 7 days of admission to hospital) or a 1.5 times increase vs the admission result within the first 7 days of admission to hospital.
Measured: <7 days from time of hospital admission
Secondary outcomes (5)
Admission to Intensive Care Unit (ICU)
Patients who have been admitted to a ward bed who then have care escalated to ICU.
Measured: At any time point during the admission under analysis i.e. from admission to either discharge from the hospital or death in-hospital, participants will be followed for the duration of hospital stay, expected average of 7 days.
Mortality
Measured: During the index hospital admission. Each participant will be followed for the duration of hospital stay, an expected average of 7 days.
Mortality associated with AKI on admission
AKI on admission defined as at least 1.5 times baseline serum creatinine or ≥354μmol/L without a baseline. Baseline defined using NHS algorithm.
Measured: During the index hospital admission. Each participant will be followed for the duration of hospital stay, an expected average of 7 days.
Magnitude of acute deterioration in Creatinine
This will be measured in both KDIGO stage: increase from Stage 1 to Stage 2 (200% increase in serum creatinine) or Stage 3 (300% increase in serum creatinine) and also peak mean increase in serum creatinine.
Measured: From admission to peak creatinine within the first 7 days of the index admission.
Requirement for renal replacement therapies
Whether patients (not normally on dialysis) require RRT during the index admission or not.
Measured: During the hospital admission. During the index hospital admission. Each participant will be followed for the duration of hospital stay, an expected average of 7 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2017 (estimated)
- Study startJul 2014
- Primary completionApr 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30,298 participants (actual)
Sponsor and investigators
- Lead sponsor
- Western Sussex Hospitals NHS Trust
- Sponsor type
- University, hospital or other
- Collaborators
- University of Southampton
- Responsible party
- Sponsor
- Investigators
- Richard Venn, MBBS, Principal investigator, Western Sussex Hospitals NHS FT
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03047382
- Sponsor's protocol ID
- 13/LO/0960
- Status last verified
- Apr 2016
- First submitted
- 1 Sep 2015
- Last updated
- 9 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Hodgson LE, Roderick PJ, Venn RM, Yao GL, Dimitrov BD, Forni LG. The ICE-AKI study: Impact analysis of a Clinical prediction rule and Electronic AKI alert in general medical patients. PLoS One. 2018 Aug 8;13(8):e0200584. doi: 10.1371/journal.pone.0200584. eCollection 2018.
PubMed 30089118
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 'Preventable Acute Kidney Injury (AKI) Should Never Occur.' The Use of a Novel Electronic Prediction Alerting Tool to Deliver an Individualised Care Package for Hospital In-patients at Risk of AKI
- ClinicalTrials.gov ID
- NCT03047382
- Acronym / sponsor ID
- 13/LO/0960
- Conditions
- Acute Kidney Injury
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30,298 participants (actual)
- Lead sponsor
- Western Sussex Hospitals NHS TrustUniversity, hospital or other
- Collaborators
- University of Southampton
- Study start
- Jul 2014
- Primary completion
- Apr 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 9 Feb 2017 (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.
Around a third of patients who develop acute kidney injury (AKI) do so after a hospital admission (hospital-acquired - HA-AKI).
The primary aim of the study is to prospectively test whether introducing a complex intervention (a 'care package' - comprising a clinical prediction rule incorporating an electronic alert which generates a checklist for patient management to relevant health professionals) can identify patients on admission to hospital who are at risk of developing HA-AKI, highlight the need for closer monitoring and allow putative preventative measures to be put in place.
The investigators will introduce the care package in one acute hospital and evaluate its effectiveness in reducing HA-AKI and its associated morbidity, over ten months, compared to a sister hospital within the same Trust (which will act as a control site). The investigators will extend evaluation for a further ten months to assess sustainability on the first site and introduce the package at the control hospital to assess generalisability. The primary aim is reducing HA-AKI, but secondary aims will include improved outcomes associated with HA-AKI, management of patients already with AKI on admission to hospital (whose care may also benefit from the checklist) and a cost-effectiveness analysis.
Detailed description
Acute Kidney Injury (AKI) is common in hospital (incidence of 10-20% - up to 70% in the critically ill), with high associated morbidity and mortality. Even small changes in renal function are associated with increased mortality. The 2009 National Confidential Enquiry into Patient Outcome and Death examined the care of patients who had died in hospital with a primary diagnosis of AKI. Over 40% of cases had an unacceptable delay in diagnosis and in 20% of cases, AKI was thought to be predictable and avoidable.
Electronic alerts have been studied for patients with established AKI, however, they have highlighted rises in creatinine after insult rather than identifying patients at risk of AKI - a third of hospital AKI cases occur after admission (HA-AKI). Risk factors have been reported in surgical and burns patients. However, strategies to identify patients admitted as medical emergencies at risk of developing AKI are lacking - the group accounting for most Intensive Care admissions with AKI.
The investigators multidisciplinary team, with significant experience utilising technology in healthcare, have developed a novel prediction score - Acute Kidney injury Prediction Score (APS). Utilising physiological measurements, biochemical parameters and known co-morbidities, the APS identifies patients at risk of developing HA-AKI following admission (1/3 of all AKI cases).
A 'care package' has been devised incorporating the APS into an automated electronic algorithm to send realtime alerts to staff on the Observation chart, e-mail the patient's Consultant and advise on a checklist. Alongside this, an E-learning AKI module for ward staff has been developed building on NICE Guidance with additional information regarding the APS.
Aims Primary: investigate whether introducing a 'care package' can reduce HA-AKI in patients admitted to hospital as an emergency.
Secondary include determining whether the intervention: reduces associated complications; improves outcomes in patients with AKI on admission; and is cost-effective.
Research Questions Primary: can a 'care package' by systematically recognising the 'at risk' patient, alerting and prompting management to staff educated in the problem, reduce HA-AKI?
Secondary:
- Can harms associated with AKI be reduced?
- Is the intervention acceptable to staff and are there barriers to implementation?
- Are improvements sustainable and can the intervention be successfully applied to a second hospital?
- Does the intervention improve outcomes of those with AKI on admission?
- Is the intervention cost-effective?
Design A prospective, non-randomised, parallel cohorts study, with before-after trial periods, at intervention and control hospital sites, will be performed. A run-in phase (10 months) for baseline data collection and prospective external validation is followed by the intervention on one site (Worthing) with the Chichester site acting as control (Phase 1) for 10 months. The intervention will then be introduced at Chichester whilst continuing at Worthing (Phase 2) for 10 months. The additional period will allow analysis of the interventions' impact on readmissions.
Potential benefits:
- Preventing morbidity and mortality including secondary complications such as chronic kidney disease (immediate and longer term).
- Reducing length of stay, thus reducing potential exposure to harm.
- Prevent requirement for renal replacement therapies and escalation to Intensive Care with associated morbidity, mortality and psychological harm.
- A Cost-effectiveness analysis will aim to demonstrate whether such a strategy could provide savings locally and to the wider health economy (short and long-term).
- Inform the healthcare community on applicability of information technology to benefit patients and improve staff engagement, with potential utilisation in a number of other conditions.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Worthing Hospital site | Active comparator | Other: AKI Care BundleAKI Care bundle instituted at Worthing site |
| Chichester Hospital site | No intervention | –Continues standard care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Admission as an emergency
- Spending at least one night as an in-patient
Key exclusion criteria (2 listed)
- Patients under 18
- Patients not admitted as emergencies or staying less than one night in hospital.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AKI Care BundlePatients identified as high risk of AKI by the electronic clinical prediction model will be managed with a care bundle of best practice. | Other | Worthing Hospital site |
Primary outcome
Hospital Acquired AKI (HA-AKI) - KDIGO rise in serum creatinine
Time frame: <7 days from time of hospital admission
HA-AKI will be defined as per KDIGO change in serum creatinine i.e. a ≥26.4μmol/L increase within a 48 hour period (during the first 7 days of admission to hospital) or a 1.5 times increase vs the admission result within the first 7 days of admission to hospital.
5 secondary outcomes
Admission to Intensive Care Unit (ICU)
Time frame: At any time point during the admission under analysis i.e. from admission to either discharge from the hospital or death in-hospital, participants will be followed for the duration of hospital stay, expected average of 7 days.
Mortality
Time frame: During the index hospital admission. Each participant will be followed for the duration of hospital stay, an expected average of 7 days.
Mortality associated with AKI on admission
Time frame: During the index hospital admission. Each participant will be followed for the duration of hospital stay, an expected average of 7 days.
Magnitude of acute deterioration in Creatinine
Time frame: From admission to peak creatinine within the first 7 days of the index admission.
Requirement for renal replacement therapies
Time frame: During the hospital admission. During the index hospital admission. Each participant will be followed for the duration of hospital stay, an expected average of 7 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 9 Feb 2017.
- Derived from this study: PubMed 30089118Hodgson LE, Roderick PJ, Venn RM, Yao GL, Dimitrov BD, Forni LG. The ICE-AKI study: Impact analysis of a Clinical prediction rule and Electronic AKI alert in general medical patients. PLoS One. 2018 Aug 8;13(8):e0200584. doi: 10.1371/journal.pone.0200584. eCollection 2018.
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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.
Richard Venn, MBBS principal investigator
Western Sussex Hospitals NHS FT
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AKI Care Bundle in people with Acute Kidney Injury, run by Western Sussex Hospitals NHS 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 2 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 9 Feb 2017. 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?
Hospital Acquired AKI (HA-AKI) - KDIGO rise in serum creatinine (time frame: <7 days from time of hospital admission). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03047382, which also lists 1 linked publication.
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 9 Feb 2017.