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Completed

NCT Number: NCT02398682

Acute Kidney Outreach to Reduce Deterioration and Death (AKORDD)

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.

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Key information

Conditions

Acute Kidney Injury Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Heart of England hospital NHS trust

Birmingham, Midlands, B9 5SS, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rapid diagnosis of AKI cause

Other

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 cause

Other

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

Other

Cessation of all potentially nephrotoxic drugs.

Other names: Avoidance of iatrogenic causes of AKI

Early nephrology followup for stage 3 AKI

Other

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

Other

Patients with AKI in the Intervention arm will receive information on preventing AKI during the study.

Other names: Patient information to reduce recurrent AKI

Good standard care

Other

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 outcomes

  1. Composite measure of participants not alive, need for dialysis, or progression of AKI stage

    Time frame: within 30 days

    Combined endpoint

Sponsors and collaborators

Lead sponsor

Heart of England NHS Trust

Other

Collaborators

  • University of Birmingham
  • University of Warwick

Registry information

Official study 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

Acronym: AKORDD

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Mar 25, 2015
Registry last updated
Feb 26, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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