Acute Kidney Outreach to Reduce Deterioration and Death (AKORDD)

Acute Kidney Injury Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02398682
• Other study ID #: PB-PG-1111-26038
• Status: Completed
• Phase: N/A
• First received: March 20, 2015
• Last updated: February 23, 2018
• Start date: October 2014
• Est. completion date: May 31, 2017

Study information

• Verified date: February 2018
• Source: Heart of England NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. The aim is to reduce morbidity and mortality in the syndrome, and also to reduce healthcare costs.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1865
• Est. completion date: May 31, 2017
• Est. primary completion date: May 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Kidney Injury

Intervention

Other:
• 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: Improved assessment of volume status Standardised use of urine dipstick . Appropriate sepsis investigations. 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.

Locations

Country	Name	City	State
United Kingdom	Heart of England hospital NHS trust	Birmingham	Midlands

Sponsors (3)

Lead Sponsor	Collaborator
Heart of England NHS Trust	University of Birmingham, University of Warwick

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite measure of participants not alive, need for dialysis, or progression of AKI stage	Combined endpoint	within 30 days