Acute Kidney Outreach to Reduce Deterioration and Death (AKORDD)
NCT ID: NCT02398682
Last Updated: 2018-02-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
1865 participants
INTERVENTIONAL
2014-10-31
2017-05-31
Brief Summary
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Detailed Description
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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
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Study Design
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NON_RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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After study Intervention arm Heartlands
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.
Rapid diagnosis of AKI cause
The 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.
Rapid treatment of AKI cause
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' drugs
Cessation of all potentially nephrotoxic drugs.
Early nephrology followup for stage 3 AKI
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 AKI
Patients with AKI in the Intervention arm will receive information on preventing AKI during the study.
Good standard care
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.
After study Control arm Good Hope
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.
Good standard care
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.
Before study Heartlands area
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.
Good standard care
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.
Before study Good Hope area
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.
Good standard care
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.
Interventions
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Rapid diagnosis of AKI cause
The 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.
Rapid treatment of AKI cause
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' drugs
Cessation of all potentially nephrotoxic drugs.
Early nephrology followup for stage 3 AKI
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 AKI
Patients with AKI in the Intervention arm will receive information on preventing AKI during the study.
Good standard care
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* AKI stage 2 or 3 (this criterion is under review during the preparatory phase of the study)
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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University of Birmingham
OTHER
University of Warwick
OTHER
Heart of England NHS Trust
OTHER
Responsible Party
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Principal Investigators
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Mark Thomas, FRCP
Role: PRINCIPAL_INVESTIGATOR
Heart of England NHS Trust
Locations
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Heart of England hospital NHS trust
Birmingham, Midlands, United Kingdom
Countries
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References
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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.
Other Identifiers
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PB-PG-1111-26038
Identifier Type: -
Identifier Source: org_study_id
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