Strategy for Uptake of Processes for Recognizing and Responding to Acute Kidney Injury

Acute Kidney Injury Clinical Trial

— SUPPORT AKI  

Official title:

Strategy for Uptake of Processes for Recognizing and Responding to Acute Kidney Injury

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03564314
• Other study ID #: REB14-1531
• Status: Completed
• Phase: N/A
• Start date: March 13, 2018
• Est. completion date: December 31, 2020

Study information

• Verified date: June 2022
• Source: University of Calgary
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2135
• Est. completion date: December 31, 2020
• Est. primary completion date: January 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Hospitalized on non-surgical units

• Receiving dialysis prior to admission on surgery unit

Related Conditions & MeSH terms

• Acute Kidney Injury
• Wounds and Injuries

Intervention

Other:
• SUPPORT AKI Clinical Decision Support
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.

Locations

Country	Name	City	State
Canada	Foothills Medical Centre	Calgary	Alberta
Canada	Peter Lougheed Centre	Calgary	Alberta
Canada	Grey Nuns Community Hospital	Edmonton	Alberta
Canada	University of Alberta Hospital	Edmonton	Alberta

Sponsors (4)

Lead Sponsor	Collaborator
University of Calgary	Alberta Health services, Covenant Health, University of Alberta

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Length of AKI hospital stay, days	Mean length of hospital stay from acute kidney injury to discharge	From date of AKI onset to discharge from hospital, assessed up to 30 days
Secondary	Resource use for AKI	Mean total health care costs of hospital care during the index admission	Duration of index hospital admission, assessed up to 30 days
Secondary	Time to initial response to AKI	Time from AKI onset to clinical response with fluid or medication management intervention	From AKI onset up to 48 hours following AKI onset
Secondary	Volume intervention (change in fluid or diuretic order) for AKI	New or modified intravenous fluid or diuretic order	Within 48 hours following AKI onset
Secondary	Adverse medication exposure	Dose modification or suspension or a medication that may cause AKI or that is cleared by the kidney	Within 48 hours following AKI onset
Secondary	Medical consultation for AKI	Consultation with nephrology or general internal medicine	Within 7 days of AKI onset
Secondary	Change in estimated Glomerular Filtration Rate (eGFR)	The difference in eGFR from baseline to 3 months after development of AKI	From most recent baseline eGFR measurement prior to AKI onset to eGFR measurement closest to 3 months after AKI onset
Secondary	Mortality	All cause mortality	Within 30 days of AKI onset