Acute Kidney InjuryAKORDDNCT02398682
Acute Kidney Outreach to Reduce Deterioration and Death (AKORDD)
A study testing Rapid diagnosis of AKI cause, Rapid treatment of AKI cause and Stopping 'nephrotoxic' drugs in people with Acute Kidney Injury, run by Heart of England NHS Trust at 1 site in United Kingdom.
Trial summary
The study pilots an outreach service for Acute kidney injury (AKI) patients, based on electronic alerts. Using the alerts we will contact the primary clinician caring for the patient with AKI in the Intervention group. The study has a control group of patients receiving good standard care, but without Outreach. 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?
- Rapid diagnosis of AKI cause, Rapid treatment of AKI cause and Stopping 'nephrotoxic' drugs
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,865 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Oct 2014to 31 May 2017
- 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
- adult patients with an Alert for AKI issued in accordance with the national algorithm for AKI alerts (NHS England)
- AKI stage 2 or 3 (this criterion is under review during the preparatory phase of the study)
Who cannot join
- patients already on dialysis for AKI at the time of alert
- patients with End stage renal disease
- patients <18 years of age
- patients with no evidence of AKI on review of the automated Alert
- patients dissenting from participation according to the Ethics application
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Heart of England hospital NHS trust
Birmingham, Midlands, B9 5SS
About this study
Official title: Acute Kidney Outreach to Reduce Deterioration and Death (AKORDD) - A Pilot Study to Look at Enhancing Patient Care, Improving Patient Outcomes and Reducing NHS Costs
The study pilots an outreach service for Acute kidney injury (AKI) patients, based on electronic alerts. Using the alerts we will contact the primary clinician caring for the patient with AKI in the Intervention group. The study has a control group of patients receiving good standard care, but without Outreach. The aim is to reduce morbidity and mortality in the syndrome, and also to reduce healthcare costs.
Read the detailed description
Lay summary:
About one in six hospital inpatients suffer Acute Kidney Injury (AKI), also called acute renal failure. About a third of patients with AKI die. The large majority of patients with AKI are managed by doctors who are not kidney experts. Effective AKI advice and treatments are available but not currently integrated into routine care. A recent National review of the care of patients who died from AKI showed poor management of many patients. Early diagnosis of AKI can avoid complications, dialysis (which affects the quality of life of patients, and is costly) or death. AKI is diagnosed by a change in a blood test. We have developed computer software to diagnose AKI earlier. It sends a warning or 'Alert' about the test to our team of kidney experts. We will further develop the settings of the Alert system. It needs to send an Alert for the right patients. We will also study the best way to make clinicians pay attention to their patients who are developing AKI. When our expert Outreach team receive an Alert, they will call the doctor or nurse looking after the patient with AKI. We will advise on the best treatment for that patient, to reduce their risk of death, dialysis and other complications. We will do a pilot study in one large hospital, to further develop the system, and check it reduces the risk of death or complications from AKI. We will use this work to develop a larger trial of this new system of care for patients with AKI in different hospitals. This will convince the wider NHS of the need to change, and show how to prevent or reduce AKI. Ultimately we aim to improve patients' lives by reducing avoidable death and illness from AKI , and also save the NHS money.
- Conditions
- Acute Kidney Injury
- Being tested
- Rapid diagnosis of AKI cause, Rapid treatment of AKI cause, Stopping 'nephrotoxic' drugs, Early nephrology followup for stage 3 AKI, Preventing recurrent AKI
- Keywords
- electronic alerts, acute kidney injury, NHS, mortality
- 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.
Rapid diagnosis of AKI causeOther
The Outreach team will advise on an evidence-based package of care:
- Rapidly establish a credible diagnosis of the cause of AKI including:
- Improved assessment of volume status
- Standardised use of urine dipstick .
- Appropriate sepsis investigations.
- Urgent ultrasound with suspected obstruction.
Rapid treatment of AKI causeOther
Rapid, limited treatment of hypovolaemia, with avoidance of iatrogenic fluid overload, recently recognised as a significant cause of mortality in AKI. Rapid sepsis therapy. Urgent relief of urinary tract obstruction.
Stopping 'nephrotoxic' drugsOther
Also called Avoidance of iatrogenic causes of AKI
Cessation of all potentially nephrotoxic drugs.
Early nephrology followup for stage 3 AKIOther
A rapid followup at discharge in an AKI clinic for survivors of stage 3 AKI, within 7 days of discharge for those in hospital, or within 7 days of the Alert for those not admitted to hospital.
Preventing recurrent AKIOther
Also called Patient information to reduce recurrent AKI
Patients with AKI in the Intervention arm will receive information on preventing AKI during the study.
Good standard careOther
Good standard care will be provided for all patients in non Experimental arms; clinicians will continue to be able to rapidly refer patients for Nephrology advice or review; online guidance will be available for all clinicians and noted in the alerts for all cases of AKI.
| Study group | Role | What they receive |
|---|---|---|
| After study Intervention arm Heartlands | Experimental | The trial has 4 arms in a Before and After design:
Arm 3. After/Heartlands area patients receiving the experimental intervention
Patients who have AKI and are either inpatients in the Intervention hospital or living within the surrounding catchment area are eligible. The intervention will be in the form of a telephone call to the primary clinician or visit to the patient. The intervention will include:
Rapid diagnosis of AKI cause; Rapid treatment of AKI cause; Stopping 'nephrotoxic' drugs; Early nephrology followup for stage 3 AKI survivors; and preventing recurrent AKI. Receives: Other: Rapid diagnosis of AKI cause; Other: Rapid treatment of AKI cause; Other: Stopping 'nephrotoxic' drugs; Other: Early nephrology followup for stage 3 AKI; Other: Preventing recurrent AKI; Other: Good standard care |
| After study Control arm Good Hope | Active comparator | The trial has 4 arms in a Before and After design:
Arm 4. After/Good Hope area patients observed whilst receiving active comparator
Patients who have AKI, as shown by having an Alert for such, and are either inpatients in Good Hope Hospital or living within the surrounding catchment area. These patients will receive good standard care (active comparator), but none of the interventions listed for the Intervention group. Receives: Other: Good standard care |
| Before study Heartlands area | Active comparator | The trial has 4 arms in a Before and After design:
Arm 1. Before/Heartlands area patients observed whilst receiving active comparator
Patients who have AKI, as shown by having an Alert for such, and are either inpatients in Heartlands Hospital or living within the surrounding catchment area. These patients will receive good standard care (active comparator), but none of the interventions listed for the Intervention group. Receives: Other: Good standard care |
| Before study Good Hope area | Active comparator | The trial has 4 arms in a Before and After design:
Arm 2. Before/Good Hope area patients observed whilst receiving active comparator
Patients who have AKI, as shown by having an Alert for such, and are either inpatients in Good Hope Hospital or living within the surrounding catchment area. These patients will receive good standard care (active comparator), but none of the interventions listed for the Intervention group. Receives: Other: Good standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite measure of participants not alive, need for dialysis, or progression of AKI stage
Combined endpoint
Measured: within 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2015 (estimated)
- Study startOct 2014
- Primary completion31 May 2017
- Study completion31 May 2017
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
- 1,865 participants (actual)
Sponsor and investigators
- Lead sponsor
- Heart of England NHS Trust
- Sponsor type
- University, hospital or other
- Collaborators
- University of Birmingham, University of Warwick
- Responsible party
- Sponsor
- Investigators
- Mark Thomas, FRCP, Principal investigator, Heart of England NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02398682
- Sponsor's protocol ID
- PB-PG-1111-26038
- Acronym
- AKORDD
- Status last verified
- Feb 2018
- First submitted
- 20 Mar 2015
- Last updated
- 26 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Contact the Chief Investigator mark.thomas@heartofengland.nhs.uk
Publications
Abdelaziz TS, Lindenmeyer A, Baharani J, Mistry H, Sitch A, Temple RM, Perkins G, Thomas M. Acute Kidney Outreach to Reduce Deterioration and Death (AKORDD) trial: the protocol for a large pilot study. BMJ Open. 2016 Aug 19;6(8):e012253. doi: 10.1136/bmjopen-2016-012253.
PubMed 27543592
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Kidney Outreach to Reduce Deterioration and Death (AKORDD) - A Pilot Study to Look at Enhancing Patient Care, Improving Patient Outcomes and Reducing NHS Costs
- ClinicalTrials.gov ID
- NCT02398682
- Acronym / sponsor ID
- AKORDD / PB-PG-1111-26038
- Conditions
- Acute Kidney Injury
- Keywords
- electronic alerts, acute kidney injury, NHS, mortality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,865 participants (actual)
- Lead sponsor
- Heart of England NHS TrustUniversity, hospital or other
- Collaborators
- University of Birmingham, University of Warwick
- Study start
- Oct 2014
- Primary completion
- 31 May 2017 (actual)
- Study completion
- 31 May 2017 (actual)
- First posted
- 25 Mar 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.
The study pilots an outreach service for Acute kidney injury (AKI) patients, based on electronic alerts. Using the alerts we will contact the primary clinician caring for the patient with AKI in the Intervention group. The study has a control group of patients receiving good standard care, but without Outreach. The aim is to reduce morbidity and mortality in the syndrome, and also to reduce healthcare costs.
Detailed description
Lay summary:
About one in six hospital inpatients suffer Acute Kidney Injury (AKI), also called acute renal failure. About a third of patients with AKI die. The large majority of patients with AKI are managed by doctors who are not kidney experts. Effective AKI advice and treatments are available but not currently integrated into routine care. A recent National review of the care of patients who died from AKI showed poor management of many patients. Early diagnosis of AKI can avoid complications, dialysis (which affects the quality of life of patients, and is costly) or death. AKI is diagnosed by a change in a blood test. We have developed computer software to diagnose AKI earlier. It sends a warning or 'Alert' about the test to our team of kidney experts. We will further develop the settings of the Alert system. It needs to send an Alert for the right patients. We will also study the best way to make clinicians pay attention to their patients who are developing AKI. When our expert Outreach team receive an Alert, they will call the doctor or nurse looking after the patient with AKI. We will advise on the best treatment for that patient, to reduce their risk of death, dialysis and other complications. We will do a pilot study in one large hospital, to further develop the system, and check it reduces the risk of death or complications from AKI. We will use this work to develop a larger trial of this new system of care for patients with AKI in different hospitals. This will convince the wider NHS of the need to change, and show how to prevent or reduce AKI. Ultimately we aim to improve patients' lives by reducing avoidable death and illness from AKI , and also save the NHS money.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| After study Intervention arm Heartlands | Experimental | Other: Rapid diagnosis of AKI cause, Other: Rapid treatment of AKI cause, Other: Stopping 'nephrotoxic' drugs, Other: Early nephrology followup for stage 3 AKI, Other: Preventing recurrent AKI, Other: Good standard careThe trial has 4 arms in a Before and After design: Arm 3. After/Heartlands area patients receiving the experimental intervention Patients who have AKI and are either inpatients in the Intervention hospital or living within the surrounding catchment area are eligible. The intervention will be in the form of a telephone call to the primary clinician or visit to the patient. The intervention will include: Rapid diagnosis of AKI cause; Rapid treatment of AKI cause; Stopping 'nephrotoxic' drugs; Early nephrology followup for stage 3 AKI survivors; and preventing recurrent AKI. |
| After study Control arm Good Hope | Active comparator | Other: Good standard careThe trial has 4 arms in a Before and After design: Arm 4. After/Good Hope area patients observed whilst receiving active comparator Patients who have AKI, as shown by having an Alert for such, and are either inpatients in Good Hope Hospital or living within the surrounding catchment area. These patients will receive good standard care (active comparator), but none of the interventions listed for the Intervention group. |
| Before study Heartlands area | Active comparator | Other: Good standard careThe trial has 4 arms in a Before and After design: Arm 1. Before/Heartlands area patients observed whilst receiving active comparator Patients who have AKI, as shown by having an Alert for such, and are either inpatients in Heartlands Hospital or living within the surrounding catchment area. These patients will receive good standard care (active comparator), but none of the interventions listed for the Intervention group. |
| Before study Good Hope area | Active comparator | Other: Good standard careThe trial has 4 arms in a Before and After design: Arm 2. Before/Good Hope area patients observed whilst receiving active comparator Patients who have AKI, as shown by having an Alert for such, and are either inpatients in Good Hope Hospital or living within the surrounding catchment area. These patients will receive good standard care (active comparator), but none of the interventions listed for the Intervention group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- adult patients with an Alert for AKI issued in accordance with the national algorithm for AKI alerts (NHS England)
- AKI stage 2 or 3 (this criterion is under review during the preparatory phase of the study)
Key exclusion criteria (5 listed)
- patients already on dialysis for AKI at the time of alert
- patients with End stage renal disease
- patients <18 years of age
- patients with no evidence of AKI on review of the automated Alert
- patients dissenting from participation according to the Ethics application
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 |
|---|---|---|
| Rapid diagnosis of AKI causeThe Outreach team will advise on an evidence-based package of care: 1) Rapidly establish a credible diagnosis of the cause of AKI including: 1. Improved assessment of volume status 2. Standardised use of urine dipstick . 3. Appropriate sepsis investigations. 4. Urgent ultrasound with suspected obstruction. | Other | After study Intervention arm Heartlands |
| Rapid treatment of AKI causeRapid, limited treatment of hypovolaemia, with avoidance of iatrogenic fluid overload, recently recognised as a significant cause of mortality in AKI. Rapid sepsis therapy. Urgent relief of urinary tract obstruction. | Other | After study Intervention arm Heartlands |
| Stopping 'nephrotoxic' drugsAlso: Avoidance of iatrogenic causes of AKICessation of all potentially nephrotoxic drugs. | Other | After study Intervention arm Heartlands |
| Early nephrology followup for stage 3 AKIA rapid followup at discharge in an AKI clinic for survivors of stage 3 AKI, within 7 days of discharge for those in hospital, or within 7 days of the Alert for those not admitted to hospital. | Other | After study Intervention arm Heartlands |
| Preventing recurrent AKIAlso: Patient information to reduce recurrent AKIPatients with AKI in the Intervention arm will receive information on preventing AKI during the study. | Other | After study Intervention arm Heartlands |
| Good standard careGood standard care will be provided for all patients in non Experimental arms; clinicians will continue to be able to rapidly refer patients for Nephrology advice or review; online guidance will be available for all clinicians and noted in the alerts for all cases of AKI. | Other | After study Control arm Good Hope, After study Intervention arm Heartlands, Before study Good Hope area, Before study Heartlands area |
Primary outcome
Composite measure of participants not alive, need for dialysis, or progression of AKI stage
Time frame: within 30 days
Combined endpoint
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 26 Feb 2018.
- Derived from this study: PubMed 27543592Abdelaziz TS, Lindenmeyer A, Baharani J, Mistry H, Sitch A, Temple RM, Perkins G, Thomas M. Acute Kidney Outreach to Reduce Deterioration and Death (AKORDD) trial: the protocol for a large pilot study. BMJ Open. 2016 Aug 19;6(8):e012253. doi: 10.1136/bmjopen-2016-012253.
- Individual participant dataSharing planned: Yes. Contact the Chief Investigator mark.thomas@heartofengland.nhs.uk
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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.
Mark Thomas, FRCP principal investigator
Heart of England NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rapid diagnosis of AKI cause, Rapid treatment of AKI cause and Stopping 'nephrotoxic' drugs in people with Acute Kidney Injury, run by Heart of England 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 5 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 26 Feb 2018. 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?
Composite measure of participants not alive, need for dialysis, or progression of AKI stage (time frame: within 30 days). 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 NCT02398682, 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 26 Feb 2018.