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Acute Kidney Outreach to Reduce Deterioration and Death (AKORDD) (AKORDD)

Primary Purpose

Acute Kidney Injury

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Rapid diagnosis of AKI cause
Rapid treatment of AKI cause
Stopping 'nephrotoxic' drugs
Early nephrology followup for stage 3 AKI
Preventing recurrent AKI
Good standard care
Sponsored by
Heart of England NHS Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Acute Kidney Injury focused on measuring electronic alerts, acute kidney injury, NHS, mortality

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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

Sites / Locations

  • Heart of England hospital NHS trust

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Active Comparator

Active Comparator

Arm Label

After study Intervention arm Heartlands

After study Control arm Good Hope

Before study Heartlands area

Before study Good Hope area

Arm Description

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

Composite measure of participants not alive, need for dialysis, or progression of AKI stage
Combined endpoint

Secondary Outcome Measures

Full Information

First Posted
March 20, 2015
Last Updated
February 23, 2018
Sponsor
Heart of England NHS Trust
Collaborators
University of Birmingham, University of Warwick
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1. Study Identification

Unique Protocol Identification Number
NCT02398682
Brief Title
Acute Kidney Outreach to Reduce Deterioration and Death (AKORDD)
Acronym
AKORDD
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
October 2014 (undefined)
Primary Completion Date
May 31, 2017 (Actual)
Study Completion Date
May 31, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Heart of England NHS Trust
Collaborators
University of Birmingham, University of Warwick

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Kidney Injury
Keywords
electronic alerts, acute kidney injury, NHS, mortality

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
1865 (Actual)

8. Arms, Groups, and Interventions

Arm Title
After study Intervention arm Heartlands
Arm Type
Experimental
Arm Description
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.
Arm Title
After study Control arm Good Hope
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Before study Heartlands area
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Before study Good Hope area
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Rapid diagnosis of AKI cause
Intervention Description
The Outreach team will advise on an evidence-based package of care: 1) 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.
Intervention Type
Other
Intervention Name(s)
Rapid treatment of AKI cause
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Stopping 'nephrotoxic' drugs
Other Intervention Name(s)
Avoidance of iatrogenic causes of AKI
Intervention Description
Cessation of all potentially nephrotoxic drugs.
Intervention Type
Other
Intervention Name(s)
Early nephrology followup for stage 3 AKI
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Preventing recurrent AKI
Other Intervention Name(s)
Patient information to reduce recurrent AKI
Intervention Description
Patients with AKI in the Intervention arm will receive information on preventing AKI during the study.
Intervention Type
Other
Intervention Name(s)
Good standard care
Intervention Description
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.
Primary Outcome Measure Information:
Title
Composite measure of participants not alive, need for dialysis, or progression of AKI stage
Description
Combined endpoint
Time Frame
within 30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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) Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark Thomas, FRCP
Organizational Affiliation
Heart of England NHS Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Heart of England hospital NHS trust
City
Birmingham
State/Province
Midlands
ZIP/Postal Code
B9 5SS
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Contact the Chief Investigator mark.thomas@heartofengland.nhs.uk
Citations:
PubMed Identifier
27543592
Citation
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.
Results Reference
derived

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Acute Kidney Outreach to Reduce Deterioration and Death (AKORDD)

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