NCT03564314

Brief Summary

Acute kidney injury (AKI) is common and costly complication of major surgery. AKI can lead to prolonged hospitalization and a higher likelihood of dialysis, chronic kidney disease and death. However, AKI can be reversed when recognized early, by ensuring that patients receive adequate fluids and medications that worsen kidney function or cause toxicity are avoided or appropriately prescribed. Past research suggests that AKI in surgical settings can be missed early in its onset, leading to delayed intervention and progression to more severe stages. The purpose of this project is to implement clinical decision support for early recognition and management of AKI on surgical units in Alberta hospitals, and to determine whether the initiative leads to improvements in the quality of care for AKI, length of hospital stay for patients, and costs to the healthcare system.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
2,135

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2018

Typical duration for not_applicable

Geographic Reach
1 country

4 active sites

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

March 13, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 25, 2018

Completed
26 days until next milestone

First Posted

Study publicly available on registry

June 20, 2018

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2020

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

November 28, 2023

Status Verified

June 1, 2022

Enrollment Period

1.9 years

First QC Date

May 25, 2018

Last Update Submit

November 27, 2023

Conditions

Acute Kidney Injury

Keywords

Acute kidney injuryMajor surgeryClinical decision support

Outcome Measures

Primary Outcomes (1)

  • Progression of AKI

    Incidence of progression of AKI to higher AKI stage (including progression to dialysis or death)

    From date of AKI onset to discharge from hospital, assessed up to 30 days

Secondary Outcomes (8)

  • Length of AKI hospital stay, days

    From date of AKI onset to discharge from hospital, assessed up to 30 days

  • Resource use for AKI

    Duration of index hospital admission, assessed up to 30 days

  • Time to initial response to AKI

    From AKI onset up to 48 hours following AKI onset

  • Volume intervention (change in fluid or diuretic order) for AKI

    Within 48 hours following AKI onset

  • Adverse medication exposure

    Within 48 hours following AKI onset

  • +3 more secondary outcomes

Study Arms (2)

SUPPORT AKI Clinical Decision Support

EXPERIMENTAL

Multidimensional clinical decision support intervention consisting of education and tools to support early recognition and management of AKI, including guidance on fluid therapies, medication management, investigation, and consultation with specialists.

Other: SUPPORT AKI Clinical Decision Support

Control

NO INTERVENTION

Usual care provided to patients with AKI on surgical units.

Interventions

SUPPORT AKI Clinical Decision SupportOTHER

Surgical units will receive a multidimensional clinical decision support intervention consisting of: (1) electronic and non-computerized tools to alert for early recognition of AKI, (2) educational program for physicians and nursing staff, (3) decision support tools with guidance on fluid therapies, medication management, investigations for AKI, and consultation with specialists.

SUPPORT AKI Clinical Decision Support

Eligibility Criteria

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

You may qualify if:

  • Adult patients (18 years of age and older) who develop hospital-acquired acute kidney injury on identified general and vascular surgery units in Alberta

You may not qualify if:

  • Hospitalized on non-surgical units
  • Receiving dialysis prior to admission on surgery unit

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Peter Lougheed Centre

Calgary, Alberta, T1Y6J4, Canada

Location

Foothills Medical Centre

Calgary, Alberta, T2N2T9, Canada

Location

University of Alberta Hospital

Edmonton, Alberta, T6G2B7, Canada

Location

Grey Nuns Community Hospital

Edmonton, Alberta, T6L5X8, Canada

Location

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

  • Matthew T James, MD, PhD

    Associate Professor

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

May 25, 2018

First Posted

June 20, 2018

Study Start

March 13, 2018

Primary Completion

January 31, 2020

Study Completion

December 31, 2020

Last Updated

November 28, 2023

Record last verified: 2022-06

Locations

CA(4)