NCT02398682

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,865

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2014

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 20, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 25, 2015

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2017

Completed
Last Updated

February 26, 2018

Status Verified

February 1, 2018

Enrollment Period

2.7 years

First QC Date

March 20, 2015

Last Update Submit

February 23, 2018

Conditions

Keywords

electronic alertsacute kidney injuryNHSmortality

Outcome Measures

Primary Outcomes (1)

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

    Combined endpoint

    within 30 days

Study Arms (4)

After study Intervention arm Heartlands

EXPERIMENTAL

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.

Other: Rapid diagnosis of AKI causeOther: Rapid treatment of AKI causeOther: Stopping 'nephrotoxic' drugsOther: Early nephrology followup for stage 3 AKIOther: Preventing recurrent AKIOther: Good standard care

After study Control arm Good Hope

ACTIVE COMPARATOR

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.

Other: Good standard care

Before study Heartlands area

ACTIVE COMPARATOR

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.

Other: Good standard care

Before study Good Hope area

ACTIVE COMPARATOR

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.

Other: Good standard care

Interventions

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.

After study Intervention arm Heartlands

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.

After study Intervention arm Heartlands

Cessation of all potentially nephrotoxic drugs.

Also known as: Avoidance of iatrogenic causes of AKI
After study Intervention arm Heartlands

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.

After study Intervention arm Heartlands

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

Also known as: Patient information to reduce recurrent AKI
After study Intervention arm Heartlands

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 HopeAfter study Intervention arm HeartlandsBefore study Good Hope areaBefore study Heartlands area

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Heart of England hospital NHS trust

Birmingham, Midlands, B9 5SS, United Kingdom

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Mark Thomas, FRCP

    Heart of England NHS Trust

    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

March 20, 2015

First Posted

March 25, 2015

Study Start

October 1, 2014

Primary Completion

May 31, 2017

Study Completion

May 31, 2017

Last Updated

February 26, 2018

Record last verified: 2018-02

Data Sharing

IPD Sharing
Will share

Contact the Chief Investigator mark.thomas@heartofengland.nhs.uk

Locations