Acute Kidney InjurySUPPORT AKINCT03564314
Strategy for Uptake of Processes for Recognizing and Responding to Acute Kidney Injury
A study testing SUPPORT AKI Clinical Decision Support in people with Acute Kidney Injury, run by University of Calgary at 4 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Kidney Injury
- What is being tested?
- SUPPORT AKI Clinical Decision Support
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,135 participants
- Where
- 4 sitesCanada
- Study dates
- 13 Mar 2018to 31 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients (18 years of age and older) who develop hospital-acquired acute kidney injury on identified general and vascular surgery units in Alberta
Who cannot join
- Hospitalized on non-surgical units
- Receiving dialysis prior to admission on surgery unit
Trial locations and contacts
4 sites in 1 country.
Canada4 sites
Peter Lougheed Centre
Calgary, Alberta, T1Y6J4
Foothills Medical Centre
Calgary, Alberta, T2N2T9
University of Alberta Hospital
Edmonton, Alberta, T6G2B7
Grey Nuns Community Hospital
Edmonton, Alberta, T6L5X8
About this study
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.
Read the detailed description
Overview: Cluster-randomized stepped-wedge trial to evaluate the impact of implementing a clinical decision support initiative for early recognition and management of hospital-acquired AKI.
Study Population: Adult patients hospitalized on surgical units in Alberta who develop acute kidney injury will be eligible if not already receiving dialysis.
Intervention: The multidimensional clinical decision support intervention consists of: (1) electronic and non-computerized tools for early recognition of AKI, (2) educational program for clinical staff, (3) decision support resources and guidance for the management of AKI and consultation with specialists.
Study Design: Using a stepped-wedge design, eight general and vascular surgery unit clusters in Calgary (Foothills Medical Centre, Peter Lougheed Centre) and Edmonton (University of Alberta Hospital, Grey Nuns Community Hospital), Alberta will be randomly ordered to be sequentially introduced to the clinical decision support intervention. The pre-implementation period will include all patients admitted to the participating hospital units in the year before the random timing of introduction of the initiative on each participating unit. The post-implementation study cohort will include patients admitted in the year after the random timing of introduction of the initiative on each unit. Analysis of processes of care and outcomes will focus on patients on these units who develop AKI during the pre- and post-implementation time periods (i.e. are eligible to receive care under the AKI decision support initiative). Additionally, health care providers (e.g. physicians, nursing staff, pharmacists) who have direct experience with the clinical decision support tools and processes will be invited to participate in the surveys and interviews pre- and post-implementation.
- Conditions
- Acute Kidney Injury
- Being tested
- SUPPORT AKI Clinical Decision Support
- Keywords
- Acute kidney injury, Major surgery, Clinical decision support
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: SUPPORT AKI Clinical Decision Support |
| Control | No intervention | Usual care provided to patients with AKI on surgical units. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression of AKI
Incidence of progression of AKI to higher AKI stage (including progression to dialysis or death)
Measured: From date of AKI onset to discharge from hospital, assessed up to 30 days
Secondary outcomes (8)
Length of AKI hospital stay, days
Mean length of hospital stay from acute kidney injury to discharge
Measured: From date of AKI onset to discharge from hospital, assessed up to 30 days
Resource use for AKI
Mean total health care costs of hospital care during the index admission
Measured: Duration of index hospital admission, assessed up to 30 days
Time to initial response to AKI
Time from AKI onset to clinical response with fluid or medication management intervention
Measured: From AKI onset up to 48 hours following AKI onset
Volume intervention (change in fluid or diuretic order) for AKI
New or modified intravenous fluid or diuretic order
Measured: Within 48 hours following AKI onset
Adverse medication exposure
Dose modification or suspension or a medication that may cause AKI or that is cleared by the kidney
Measured: Within 48 hours following AKI onset
Medical consultation for AKI
Consultation with nephrology or general internal medicine
Measured: Within 7 days of AKI onset
Change in estimated Glomerular Filtration Rate (eGFR)
The difference in eGFR from baseline to 3 months after development of AKI
Measured: From most recent baseline eGFR measurement prior to AKI onset to eGFR measurement closest to 3 months after AKI onset
Mortality
All cause mortality
Measured: Within 30 days of AKI onset
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2018
- Study start13 Mar 2018
- Primary completion31 Jan 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- More trials run by University of CalgaryThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 2,135 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Collaborators
- Alberta Health services, University of Alberta, Covenant Health, Canada
- Responsible party
- Sponsor
- Investigators
- Matthew T James, MD, PhD, Principal investigator, Associate Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03564314
- Sponsor's protocol ID
- REB14-1531
- Acronym
- SUPPORT AKI
- Status last verified
- Jun 2022
- First submitted
- 25 May 2018
- Last updated
- 28 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Strategy for Uptake of Processes for Recognizing and Responding to Acute Kidney Injury
- ClinicalTrials.gov ID
- NCT03564314
- Acronym / sponsor ID
- SUPPORT AKI / REB14-1531
- Conditions
- Acute Kidney Injury
- Keywords
- Acute kidney injury, Major surgery, Clinical decision support
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,135 participants (actual)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Collaborators
- Alberta Health services, University of Alberta, Covenant Health, Canada
- Study start
- 13 Mar 2018 (actual)
- Primary completion
- 31 Jan 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 20 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Overview: Cluster-randomized stepped-wedge trial to evaluate the impact of implementing a clinical decision support initiative for early recognition and management of hospital-acquired AKI.
Study Population: Adult patients hospitalized on surgical units in Alberta who develop acute kidney injury will be eligible if not already receiving dialysis.
Intervention: The multidimensional clinical decision support intervention consists of: (1) electronic and non-computerized tools for early recognition of AKI, (2) educational program for clinical staff, (3) decision support resources and guidance for the management of AKI and consultation with specialists.
Study Design: Using a stepped-wedge design, eight general and vascular surgery unit clusters in Calgary (Foothills Medical Centre, Peter Lougheed Centre) and Edmonton (University of Alberta Hospital, Grey Nuns Community Hospital), Alberta will be randomly ordered to be sequentially introduced to the clinical decision support intervention. The pre-implementation period will include all patients admitted to the participating hospital units in the year before the random timing of introduction of the initiative on each participating unit. The post-implementation study cohort will include patients admitted in the year after the random timing of introduction of the initiative on each unit. Analysis of processes of care and outcomes will focus on patients on these units who develop AKI during the pre- and post-implementation time periods (i.e. are eligible to receive care under the AKI decision support initiative). Additionally, health care providers (e.g. physicians, nursing staff, pharmacists) who have direct experience with the clinical decision support tools and processes will be invited to participate in the surveys and interviews pre- and post-implementation.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SUPPORT AKI Clinical Decision Support | Experimental | Other: SUPPORT AKI Clinical Decision SupportMultidimensional 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. |
| Control | No intervention | –Usual care provided to patients with AKI on surgical units. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients (18 years of age and older) who develop hospital-acquired acute kidney injury on identified general and vascular surgery units in Alberta
Key exclusion criteria (2 listed)
- Hospitalized on non-surgical units
- Receiving dialysis prior to admission on surgery unit
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SUPPORT AKI Clinical Decision SupportSurgical 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. | Other | SUPPORT AKI Clinical Decision Support |
Primary outcome
Progression of AKI
Time frame: From date of AKI onset to discharge from hospital, assessed up to 30 days
Incidence of progression of AKI to higher AKI stage (including progression to dialysis or death)
8 secondary outcomes
Length of AKI hospital stay, days
Time frame: From date of AKI onset to discharge from hospital, assessed up to 30 days
Resource use for AKI
Time frame: Duration of index hospital admission, assessed up to 30 days
Time to initial response to AKI
Time frame: From AKI onset up to 48 hours following AKI onset
Volume intervention (change in fluid or diuretic order) for AKI
Time frame: Within 48 hours following AKI onset
Adverse medication exposure
Time frame: Within 48 hours following AKI onset
Medical consultation for AKI
Time frame: Within 7 days of AKI onset
Change in estimated Glomerular Filtration Rate (eGFR)
Time frame: From most recent baseline eGFR measurement prior to AKI onset to eGFR measurement closest to 3 months after AKI onset
Mortality
Time frame: Within 30 days of AKI onset
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthew T James, MD, PhD principal investigator
Associate Professor
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SUPPORT AKI Clinical Decision Support in people with Acute Kidney Injury, run by University of Calgary at 4 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression of AKI (time frame: From date of AKI onset to discharge from hospital, assessed up to 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2023; AzTrials last refreshed its copy on 4 Nov 2026.