Acute Kidney InjuryIMPROVE-AKINCT03556293
IMPROVE AKI Cluster-Randomized Trial
A study testing AKI Prevention Toolkit, Technical Assistance (TA) and Virtual Learning Collaborative (VLC) in people with Acute Kidney Injury, run by Dartmouth-Hitchcock Medical Center at 2 sites in United States.
Trial summary
When a person has an imaging procedure that uses radio-contrast dye, there is a possibility of damage to that person's kidneys, which could result in being on dialysis or early death. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Acute Kidney Injury
- What is being tested?
- AKI Prevention Toolkit, Technical Assistance (TA) and Virtual Learning Collaborative (VLC)
- Type of treatment
- Pill or oral medicine, Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10,252 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Sep 2019to 31 Jan 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- VA Site Inclusion Criteria: All VA medical centers with a cardiac catheterization laboratory are eligible, and all catheterization operators at a site are included.
- Patient Inclusion Criteria: Among these sites, only patients aged 18 or greater with pre-existing CKD who undergo diagnostic coronary angiography or percutaneous coronary intervention (PCI or angioplasty) will be enrolled in the trial. CKD will be determined by a pre-existing CKD diagnosis in the VA medical record, or by two or more estimated glomerular filtration rates <60 (ml/min/1.73 m2) at least 90-days apart prior to presentation.
Who cannot join
- Patient Exclusion Criteria: Patients with a history of dialysis (hemodialysis, peritoneal dialysis), under the age of 18, or no evidence of pre-existing CKD will be excluded. Cardiac catheterization (also referred to as coronary angiography) is defined as a procedure in which a catheter is inserted into the femoral or radial artery and is threaded to the cardiac vasculature where radio-contrast dye is administered and a series of x-rays obtained in order to visualize the coronary arterial anatomy. PCI is when a clinical intervention is then performed to address any treatable pathology that is found.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Tennesee Valley VA
Nashville, Tennessee, 37212
White River Junction VA
White River Junction, Vermont, 05001
About this study
Official title: IMPROVE AKI: A Cluster-Randomized Trial of Team-Based Coaching Interventions to IMPROVE Acute Kidney Injury
When a person has an imaging procedure that uses radio-contrast dye, there is a possibility of damage to that person's kidneys, which could result in being on dialysis or early death. The investigators are testing novel coaching and automated tools to help healthcare teams apply approaches that have been shown to prevent damage to kidneys during a cardiac catheterization procedure. The results of our study will help inform health care leaders on how to implement low-cost preventive strategies through team-based coaching and surveillance reporting for kidney injury and other patient safety priorities to every hospital in the United States.
Read the detailed description
The investigators propose to test the implementation of evidence-based preventive interventions through a Virtual Learning Collaborative (VLC) with and without the novel use Automated Surveillance Reporting (ASR) intervention to change clinical practice and improve patient safety in common diagnostic procedures. Over 2 million people in the United States undergo diagnostic or interventional cardiac catheterization each year. Acute kidney injury (AKI), a patient safety metric set by the National Quality Forum, occurs in up to 14% of all patients following a procedure and up to 50% in patients with pre-existing chronic kidney disease (CKD), making AKI the most prevalent adverse event. Patients developing AKI have an increased risk of serious adverse events. There are widely accepted interventions to prevent AKI in patients undergoing cardiac catheterization. Our research team has demonstrated AKI can be prevented in 28% of patients with CKD through a large regional pilot. Our team has already developed ASR techniques for AKI nationally within the Veterans' Administration. Based on our own preliminary studies, the investigators hypothesize the incorporation of an automated plug-in ASR toolkit to provide near-realtime feedback to front-line care teams will significantly augment both VLC and Technical Assistance (TA) interventions in implementation trials. Our objective is to conduct a national randomized clinical trial testing the use of VLC or TA with or without a plug-in ASR toolkit to determine if ASR significantly improves outcomes for patients undergoing procedures with contrast dye to overcome the inconsistent application of known ways to prevent AKI. The rationale underlying the project is that ASR could prove to be a plug-in vehicle to improve patient endpoints in evidence-based preventive interventions in common diagnostic procedures. The investigators plan to test our hypothesis through the following specific aims in a 2x2 factorial cluster-randomized trial. For all aims, 16 hospitals will be randomized to receive one of the following interventions for 18-months: A) Technical Assistance (TA); B) Technical Assistance with Automated Surveillance Reporting (TA+ASR); C) Virtual Learning Collaborative (VLC) with team-based coaching (VLC); and D) Virtual Learning Collaborative with Automated Surveillance Reporting (VLC+ASR). Specific Aim 1: Compare the efficacy of a VLC and/or ASR compared to TA to reduce the incidence of AKI. Specific Aim 2: Evaluate the sustained efficacy of VLC and/or ASR to reduce the incidence of AKI following the intervention period. The interventions proposed use novel interactive video coaching sessions and ASR as low-cost scalable implementation strategies to prevent a clinical endpoint (AKI). Eighteen hospitals have agreed to participate and be randomized. The investigators expect the impact of a plug-in ASR to augment evidence based preventive interventions and VLC could significantly improve the consistent application of these interventions and implementation trials. In our opinion, our study will open the door to a new paradigm of implementation science seeking to continuously improve health care.
- Conditions
- Acute Kidney Injury
- Being tested
- AKI Prevention Toolkit, Technical Assistance (TA), Virtual Learning Collaborative (VLC), Automated Surveillance Reporting (ASR)
- 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.
AKI Prevention ToolkitBehavioural
AKI Prevention Toolkit. Intervention: All sites will receive the AKI Prevention Toolkit including 3 core interventions: 1. Standardized order sets; 2. IV and oral fluids; and 3. Reduced contrast volume. The interventions adhere to the KDIGO guidelines and add interventions developed and tested in our pilot intervention to implement AKI preventive strategies.
Technical Assistance (TA)Behavioural
Technical Assistance (TA). Intervention: TA will be offered to the 8 teams randomized to the TA condition and will receive the AKI Prevention Toolkit plus monthly technical calls independently. TA arms will include TA with and without automated surveillance reporting (ASR).
Virtual Learning Collaborative (VLC)Behavioural
Virtual Learning Collaborative (VLC). Intervention: The VLC will be offered to 8 teams and will receive the AKI Prevention Toolkit plus monthly virtual training calls with the other VLC sites. Each participating site will be supported to establish a multidisciplinary team charged with continuously improving AKI, which will include interventional cardiologists, cardiac catheterization lab manager and technicians, nursing representatives from the intensive care unit and/or holding areas, cardiology administration, nephrology, and representation from the quality improvement department (VA Clinical Application Coordinator [CAC] and Systems Redesign). VLC arms will include VLC with and without automated surveillance reporting (ASR).
Automated Surveillance Reporting (ASR)Behavioural
Automated Surveillance Reporting (ASR). Intervention: The ASR will be offered to 8 teams. In addition to either TA or VLC, ASR teams will receive automated monthly reports in the form of an dashboard focused on AKI outcome and preventative measures overtime. The ASR report will be customized to each team and each individual operator and linked to their national VA-CART registry.
| Study group | Role | What they receive |
|---|---|---|
| Technical Assistance (No ASR) | Active comparator | Technical Assistance (TA). Intervention: TA will be offered to the 4 teams randomized to the TA condition without automated surveillance reporting and will receive the AKI Prevention Toolkit plus monthly technical calls independently Receives: Behavioral: AKI Prevention Toolkit; Behavioral: Technical Assistance (TA) |
| Virtual Learning Collaborative (No ASR) | Active comparator | Virtual Learning Collaborative (VLC). Intervention: The VLC will be offered to 4 teams without automated surveillance reportingand will receive the AKI Prevention Toolkit plus monthly virtual training calls with the other VLC sites. Each participating site will be supported to establish a multidisciplinary team charged with continuously improving AKI, which will include interventional cardiologists, cardiac catheterization lab manager and technicians, nursing representatives from the intensive care unit and/or holding areas, cardiology administration, nephrology, and representation from the quality improvement department (VA Clinical Application Coordinator [CAC] and Systems Redesign). Receives: Behavioral: AKI Prevention Toolkit; Behavioral: Virtual Learning Collaborative (VLC) |
| Technical Assistance with ASR | Active comparator | Technical Assistance (TA). Intervention: TA will be offered to the 4 teams randomized to the TA condition with automated surveillance reporting (ASR) and will receive the AKI Prevention Toolkit plus monthly technical calls independently and monthly ASR dashboard. Receives: Behavioral: AKI Prevention Toolkit; Behavioral: Technical Assistance (TA); Behavioral: Automated Surveillance Reporting (ASR) |
| Virtual Learning Collaborative with ASR | Active comparator | Virtual Learning Collaborative (VLC). Intervention: The VLC will be offered to 4 teams with automated surveillance reporting (ASR) and will receive the AKI Prevention Toolkit plus monthly virtual training calls with the other VLC sites with the and monthly ASR dashboard. Each participating site will be supported to establish a multidisciplinary team charged with continuously improving AKI, which will include interventional cardiologists, cardiac catheterization lab manager and technicians, nursing representatives from the intensive care unit and/or holding areas, cardiology administration, nephrology, and representation from the quality improvement department (VA Clinical Application Coordinator [CAC] and Systems Redesign). Receives: Behavioral: AKI Prevention Toolkit; Behavioral: Virtual Learning Collaborative (VLC); Behavioral: Automated Surveillance Reporting (ASR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute Kidney Injury
Number of Participants with Acute Kidney Injury
Measured: within 48-hours of the procedure or within 7-days for in-patients, or onset of dialysis within 7-days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2018
- Study start1 Sep 2019
- Primary completion30 Nov 2022
- Study completion31 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- 2x2 factorial cluster randomized trial
- Masking
- None (open label)
- Enrolment
- 10,252 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dartmouth-Hitchcock Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Vanderbilt University, University of Vermont, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Responsible party
- Principal investigator, Jeremiah R. Brown, Dartmouth-Hitchcock Medical Center
- Investigators
- Jeremiah R Brown, PhD, Principal investigator, Dartmouth College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03556293
- Sponsor's protocol ID
- D18114
- Other IDs
- R01DK113201
- Acronym
- IMPROVE-AKI
- Status last verified
- Mar 2025
- First submitted
- 30 Apr 2018
- Last updated
- 18 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Tools (data, software, libraries, research tools, etc.) will be made available to all researchers in both the private and public sector free or for a nominal charge and with minimal restriction. An analytic program file used to produce the analyses and a de-identified dataset will be made available to third parties within the VA system to conduct confirmatory analyses for the proposed specific aims. All parties must be in compliance with VA regulations and access. All analytic program files (code) and results will be reported in supplementary appendixes for all publications.
Publications
Matheny ME, Carpenter-Song E, Ricket IM, Solomon RJ, Stabler ME, Davis SE, Zubkoff L, Westerman DM, Dorn C, Cox KC, Minter FF, Jneid H, Currier JW, Athar SA, Girotra S, Leung C, Helton TJ, Agarwal A, Vidovich MI, Plomondon ME, Waldo SW, Aschbrenner KA, McKay V, O'Malley AJ, Brown JR. Sustained Improvements After Intervention to Prevent Contrast-Associated Acute Kidney Injury: A Randomized Controlled Trial. J Am Heart Assoc. 2025 May 20;14(10):e038920. doi: 10.1161/JAHA.124.038920. Epub 2025 May 15.
PubMed 40371586Brown JR, Solomon R, Stabler ME, Davis S, Carpenter-Song E, Zubkoff L, Westerman DM, Dorn C, Cox KC, Minter F, Jneid H, Currier JW, Athar SA, Girotra S, Leung C, Helton TJ, Agarwal A, Vidovich MI, Plomondon ME, Waldo SW, Aschbrenner KA, O'Malley AJ, Matheny ME. Team-Based Coaching Intervention to Improve Contrast-Associated Acute Kidney Injury: A Cluster-Randomized Trial. Clin J Am Soc Nephrol. 2023 Mar 1;18(3):315-326. doi: 10.2215/CJN.0000000000000067. Epub 2023 Feb 8.
PubMed 36787125
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IMPROVE AKI: A Cluster-Randomized Trial of Team-Based Coaching Interventions to IMPROVE Acute Kidney Injury
- ClinicalTrials.gov ID
- NCT03556293
- Acronym / sponsor ID
- IMPROVE-AKI / D18114
- Conditions
- Acute Kidney Injury
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10,252 participants (actual)
- Lead sponsor
- Dartmouth-Hitchcock Medical CenterUniversity, hospital or other
- Collaborators
- Vanderbilt University, University of Vermont, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 30 Nov 2022 (actual)
- Study completion
- 31 Jan 2023 (actual)
- First posted
- 14 Jun 2018 (actual)
- Results
- Posted 18 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
When a person has an imaging procedure that uses radio-contrast dye, there is a possibility of damage to that person's kidneys, which could result in being on dialysis or early death. The investigators are testing novel coaching and automated tools to help healthcare teams apply approaches that have been shown to prevent damage to kidneys during a cardiac catheterization procedure. The results of our study will help inform health care leaders on how to implement low-cost preventive strategies through team-based coaching and surveillance reporting for kidney injury and other patient safety priorities to every hospital in the United States.
Detailed description
The investigators propose to test the implementation of evidence-based preventive interventions through a Virtual Learning Collaborative (VLC) with and without the novel use Automated Surveillance Reporting (ASR) intervention to change clinical practice and improve patient safety in common diagnostic procedures. Over 2 million people in the United States undergo diagnostic or interventional cardiac catheterization each year. Acute kidney injury (AKI), a patient safety metric set by the National Quality Forum, occurs in up to 14% of all patients following a procedure and up to 50% in patients with pre-existing chronic kidney disease (CKD), making AKI the most prevalent adverse event. Patients developing AKI have an increased risk of serious adverse events. There are widely accepted interventions to prevent AKI in patients undergoing cardiac catheterization. Our research team has demonstrated AKI can be prevented in 28% of patients with CKD through a large regional pilot. Our team has already developed ASR techniques for AKI nationally within the Veterans' Administration. Based on our own preliminary studies, the investigators hypothesize the incorporation of an automated plug-in ASR toolkit to provide near-realtime feedback to front-line care teams will significantly augment both VLC and Technical Assistance (TA) interventions in implementation trials. Our objective is to conduct a national randomized clinical trial testing the use of VLC or TA with or without a plug-in ASR toolkit to determine if ASR significantly improves outcomes for patients undergoing procedures with contrast dye to overcome the inconsistent application of known ways to prevent AKI. The rationale underlying the project is that ASR could prove to be a plug-in vehicle to improve patient endpoints in evidence-based preventive interventions in common diagnostic procedures. The investigators plan to test our hypothesis through the following specific aims in a 2x2 factorial cluster-randomized trial. For all aims, 16 hospitals will be randomized to receive one of the following interventions for 18-months: A) Technical Assistance (TA); B) Technical Assistance with Automated Surveillance Reporting (TA+ASR); C) Virtual Learning Collaborative (VLC) with team-based coaching (VLC); and D) Virtual Learning Collaborative with Automated Surveillance Reporting (VLC+ASR). Specific Aim 1: Compare the efficacy of a VLC and/or ASR compared to TA to reduce the incidence of AKI. Specific Aim 2: Evaluate the sustained efficacy of VLC and/or ASR to reduce the incidence of AKI following the intervention period. The interventions proposed use novel interactive video coaching sessions and ASR as low-cost scalable implementation strategies to prevent a clinical endpoint (AKI). Eighteen hospitals have agreed to participate and be randomized. The investigators expect the impact of a plug-in ASR to augment evidence based preventive interventions and VLC could significantly improve the consistent application of these interventions and implementation trials. In our opinion, our study will open the door to a new paradigm of implementation science seeking to continuously improve health care.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- 2x2 factorial cluster randomized trial
| Arm | Type | Receives |
|---|---|---|
| Technical Assistance (No ASR) | Active comparator | Behavioral: AKI Prevention Toolkit, Behavioral: Technical Assistance (TA)Technical Assistance (TA). Intervention: TA will be offered to the 4 teams randomized to the TA condition without automated surveillance reporting and will receive the AKI Prevention Toolkit plus monthly technical calls independently |
| Virtual Learning Collaborative (No ASR) | Active comparator | Behavioral: AKI Prevention Toolkit, Behavioral: Virtual Learning Collaborative (VLC)Virtual Learning Collaborative (VLC). Intervention: The VLC will be offered to 4 teams without automated surveillance reportingand will receive the AKI Prevention Toolkit plus monthly virtual training calls with the other VLC sites. Each participating site will be supported to establish a multidisciplinary team charged with continuously improving AKI, which will include interventional cardiologists, cardiac catheterization lab manager and technicians, nursing representatives from the intensive care unit and/or holding areas, cardiology administration, nephrology, and representation from the quality improvement department (VA Clinical Application Coordinator [CAC] and Systems Redesign). |
| Technical Assistance with ASR | Active comparator | Behavioral: AKI Prevention Toolkit, Behavioral: Technical Assistance (TA), Behavioral: Automated Surveillance Reporting (ASR)Technical Assistance (TA). Intervention: TA will be offered to the 4 teams randomized to the TA condition with automated surveillance reporting (ASR) and will receive the AKI Prevention Toolkit plus monthly technical calls independently and monthly ASR dashboard. |
| Virtual Learning Collaborative with ASR | Active comparator | Behavioral: AKI Prevention Toolkit, Behavioral: Virtual Learning Collaborative (VLC), Behavioral: Automated Surveillance Reporting (ASR)Virtual Learning Collaborative (VLC). Intervention: The VLC will be offered to 4 teams with automated surveillance reporting (ASR) and will receive the AKI Prevention Toolkit plus monthly virtual training calls with the other VLC sites with the and monthly ASR dashboard. Each participating site will be supported to establish a multidisciplinary team charged with continuously improving AKI, which will include interventional cardiologists, cardiac catheterization lab manager and technicians, nursing representatives from the intensive care unit and/or holding areas, cardiology administration, nephrology, and representation from the quality improvement department (VA Clinical Application Coordinator [CAC] and Systems Redesign). |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- VA Site Inclusion Criteria: All VA medical centers with a cardiac catheterization laboratory are eligible, and all catheterization operators at a site are included.
- Patient Inclusion Criteria: Among these sites, only patients aged 18 or greater with pre-existing CKD who undergo diagnostic coronary angiography or percutaneous coronary intervention (PCI or angioplasty) will be enrolled in the trial. CKD will be determined by a pre-existing CKD diagnosis in the VA medical record, or by two or more estimated glomerular filtration rates <60 (ml/min/1.73 m2) at least 90-days apart prior to presentation.
Key exclusion criteria (1 listed)
- Patient Exclusion Criteria: Patients with a history of dialysis (hemodialysis, peritoneal dialysis), under the age of 18, or no evidence of pre-existing CKD will be excluded. Cardiac catheterization (also referred to as coronary angiography) is defined as a procedure in which a catheter is inserted into the femoral or radial artery and is threaded to the cardiac vasculature where radio-contrast dye is administered and a series of x-rays obtained in order to visualize the coronary arterial anatomy. PCI is when a clinical intervention is then performed to address any treatable pathology that is found.
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 |
|---|---|---|
| AKI Prevention ToolkitAKI Prevention Toolkit. Intervention: All sites will receive the AKI Prevention Toolkit including 3 core interventions: 1. Standardized order sets; 2. IV and oral fluids; and 3. Reduced contrast volume. The interventions adhere to the KDIGO guidelines and add interventions developed and tested in our pilot intervention to implement AKI preventive strategies. | Behavioural | Technical Assistance (No ASR), Technical Assistance with ASR, Virtual Learning Collaborative (No ASR), Virtual Learning Collaborative with ASR |
| Technical Assistance (TA)Technical Assistance (TA). Intervention: TA will be offered to the 8 teams randomized to the TA condition and will receive the AKI Prevention Toolkit plus monthly technical calls independently. TA arms will include TA with and without automated surveillance reporting (ASR). | Behavioural | Technical Assistance (No ASR), Technical Assistance with ASR |
| Virtual Learning Collaborative (VLC)Virtual Learning Collaborative (VLC). Intervention: The VLC will be offered to 8 teams and will receive the AKI Prevention Toolkit plus monthly virtual training calls with the other VLC sites. Each participating site will be supported to establish a multidisciplinary team charged with continuously improving AKI, which will include interventional cardiologists, cardiac catheterization lab manager and technicians, nursing representatives from the intensive care unit and/or holding areas, cardiology administration, nephrology, and representation from the quality improvement department (VA Clinical Application Coordinator [CAC] and Systems Redesign). VLC arms will include VLC with and without automated surveillance reporting (ASR). | Behavioural | Virtual Learning Collaborative (No ASR), Virtual Learning Collaborative with ASR |
| Automated Surveillance Reporting (ASR)Automated Surveillance Reporting (ASR). Intervention: The ASR will be offered to 8 teams. In addition to either TA or VLC, ASR teams will receive automated monthly reports in the form of an dashboard focused on AKI outcome and preventative measures overtime. The ASR report will be customized to each team and each individual operator and linked to their national VA-CART registry. | Behavioural | Technical Assistance with ASR, Virtual Learning Collaborative with ASR |
Primary outcome
Acute Kidney Injury
Time frame: within 48-hours of the procedure or within 7-days for in-patients, or onset of dialysis within 7-days
Number of Participants with Acute Kidney Injury
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40371586Matheny ME, Carpenter-Song E, Ricket IM, Solomon RJ, Stabler ME, Davis SE, Zubkoff L, Westerman DM, Dorn C, Cox KC, Minter FF, Jneid H, Currier JW, Athar SA, Girotra S, Leung C, Helton TJ, Agarwal A, Vidovich MI, Plomondon ME, Waldo SW, Aschbrenner KA, McKay V, O'Malley AJ, Brown JR. Sustained Improvements After Intervention to Prevent Contrast-Associated Acute Kidney Injury: A Randomized Controlled Trial. J Am Heart Assoc. 2025 May 20;14(10):e038920. doi: 10.1161/JAHA.124.038920. Epub 2025 May 15.
- Derived from this study: PubMed 36787125Brown JR, Solomon R, Stabler ME, Davis S, Carpenter-Song E, Zubkoff L, Westerman DM, Dorn C, Cox KC, Minter F, Jneid H, Currier JW, Athar SA, Girotra S, Leung C, Helton TJ, Agarwal A, Vidovich MI, Plomondon ME, Waldo SW, Aschbrenner KA, O'Malley AJ, Matheny ME. Team-Based Coaching Intervention to Improve Contrast-Associated Acute Kidney Injury: A Cluster-Randomized Trial. Clin J Am Soc Nephrol. 2023 Mar 1;18(3):315-326. doi: 10.2215/CJN.0000000000000067. Epub 2023 Feb 8.
- Individual participant dataSharing planned: Yes. Tools (data, software, libraries, research tools, etc.) will be made available to all researchers in both the private and public sector free or for a nominal charge and with minimal restriction. An analytic program file used to produce the analyses and a de-identified dataset will be made available to third parties within the VA system to conduct confirmatory analyses for the proposed specific aims. All parties must be in compliance with VA regulations and access. All analytic program files (code) and results will be reported in supplementary appendixes for all publications.
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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.
Jeremiah R Brown, PhD principal investigator
Dartmouth College
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AKI Prevention Toolkit, Technical Assistance (TA) and Virtual Learning Collaborative (VLC) in people with Acute Kidney Injury, run by Dartmouth-Hitchcock Medical Center at 2 sites in United States.
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 2 inclusion and 1 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 18 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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?
Yes. Results are posted in the registry (first posted 18 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Acute Kidney Injury (time frame: within 48-hours of the procedure or within 7-days for in-patients, or onset of dialysis within 7-days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03556293, which also lists 2 linked publications.
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 18 Mar 2025.