Electronic Alerting Tool to Help Prevent Acute Kidney Injury

NCT03047382 | Completed

• 1 other identifier: 13/LO/0960
• Study Type: interventional
• Target: 30,298
• Locations: 1 country
• Sites: 1

Brief Summary

Around a third of patients who develop acute kidney injury (AKI) do so after a hospital admission (hospital-acquired - HA-AKI). The primary aim of the study is to prospectively test whether introducing a complex intervention (a 'care package' - comprising a clinical prediction rule incorporating an electronic alert which generates a checklist for patient management to relevant health professionals) can identify patients on admission to hospital who are at risk of developing HA-AKI, highlight the need for closer monitoring and allow putative preventative measures to be put in place. The investigators will introduce the care package in one acute hospital and evaluate its effectiveness in reducing HA-AKI and its associated morbidity, over ten months, compared to a sister hospital within the same Trust (which will act as a control site). The investigators will extend evaluation for a further ten months to assess sustainability on the first site and introduce the package at the control hospital to assess generalisability. The primary aim is reducing HA-AKI, but secondary aims will include improved outcomes associated with HA-AKI, management of patients already with AKI on admission to hospital (whose care may also benefit from the checklist) and a cost-effectiveness analysis.

Conditions

Acute Kidney Injury

Outcome Measures

Primary Outcomes (1)

• Hospital Acquired AKI (HA-AKI) - KDIGO rise in serum creatinine

  HA-AKI will be defined as per KDIGO change in serum creatinine i.e. a ≥26.4μmol/L increase within a 48 hour period (during the first 7 days of admission to hospital) or a 1.5 times increase vs the admission result within the first 7 days of admission to hospital.

  <7 days from time of hospital admission

Secondary Outcomes (5)

• Admission to Intensive Care Unit (ICU)

  At any time point during the admission under analysis i.e. from admission to either discharge from the hospital or death in-hospital, participants will be followed for the duration of hospital stay, expected average of 7 days.

• Mortality

  During the index hospital admission. Each participant will be followed for the duration of hospital stay, an expected average of 7 days.

• Mortality associated with AKI on admission

  During the index hospital admission. Each participant will be followed for the duration of hospital stay, an expected average of 7 days.

• Magnitude of acute deterioration in Creatinine

  From admission to peak creatinine within the first 7 days of the index admission.

• Requirement for renal replacement therapies

  During the hospital admission. During the index hospital admission. Each participant will be followed for the duration of hospital stay, an expected average of 7 days.

Study Arms (2)

Worthing Hospital site

ACTIVE COMPARATOR

AKI Care bundle instituted at Worthing site

Other: AKI Care Bundle

Chichester Hospital site

NO INTERVENTION

Continues standard care

Interventions

AKI Care Bundle OTHER

Patients identified as high risk of AKI by the electronic clinical prediction model will be managed with a care bundle of best practice.

Worthing Hospital site

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Admission as an emergency
• Spending at least one night as an in-patient

You may not qualify if:

• Patients under 18
• Patients not admitted as emergencies or staying less than one night in hospital.

Sponsors & Collaborators

• Western Sussex Hospitals NHS Trust: lead
• University of Southampton: collaborator

Study Sites (1)

Western Sussex Hospitals NHS Foundation Trust

Worthing, West Suusex, United Kingdom

Location

Related Publications (1)

• Hodgson LE, Roderick PJ, Venn RM, Yao GL, Dimitrov BD, Forni LG. The ICE-AKI study: Impact analysis of a Clinical prediction rule and Electronic AKI alert in general medical patients. PLoS One. 2018 Aug 8;13(8):e0200584. doi: 10.1371/journal.pone.0200584. eCollection 2018.

  PMID: 30089118 DERIVED

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Richard Venn, MBBS

  Western Sussex Hospitals NHS FT

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2015
• First Posted: February 9, 2017
• Study Start: July 1, 2014
• Primary Completion: April 1, 2016
• Study Completion: October 1, 2016
• Last Updated: February 9, 2017

Record last verified: 2016-04

Locations

GB (1)