Acute Kidney InjuryNCT04585555
Physiologic Signals and Signatures With the Accuryn Monitoring System (The Accuryn Registry)
An observational study of Acute Kidney Injury and Abdominal Compartment Syndrome, run by Potrero Medical at 1 site in United States.
Trial summary
The Accuryn Registry Study is an open-ended, global, multi-center, retrospective and prospective, single-arm data collection study with an FDA cleared device. The target population are cardiovascular surgery patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Kidney Injury, Abdominal Compartment Syndrome, Intraabdominal Hypertension
- What is being tested?
- Accuryn Monitoring System
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jul 2017to 5 Nov 2019
- How long will I take part?
- 30 Days
- Phase
- Observational
- 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
Study population: Patients undergoing cardiovascular surgical intervention(s) monitored with the Accuryn Monitoring System (per standard of care) during their hospital stay.
Who may be able to join
- Adult (age ≥ 18).
- Monitored on the Accuryn® Monitoring System during hospital stay.
- Patient is undergoing cardiovascular surgical intervention(s).
Who cannot join
- 1. The patient is unsuitable for the study, in the opinion of the investigator. This may include vulnerable patient populations such as prisoners or those detained in a penal institution.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Physiologic Signals and Signatures With the Accuryn Monitoring System - A Retrospective and Prospective Analysis (The Accuryn Registry)
The Accuryn Registry Study is an open-ended, global, multi-center, retrospective and prospective, single-arm data collection study with an FDA cleared device. The target population are cardiovascular surgery patients. Physiologic data measurements will be collected from enrolled subjects using electronic medical records and data streams via the Accuryn Monitoring System.
Read the detailed description
The primary objective of the Accuryn Registry Study is to is to track and analyze changes in physiologic data streams using the Accuryn Monitoring System and correlate these changes to the occurrence of acute kidney injury (AKI) following cardiovascular surgery intervention(s).
The secondary objective is to determine the incidence of IAH and ACS in the cardiovascular surgery population and the correlation of these diagnoses to the diagnosis of AKI.
- Conditions
- Acute Kidney Injury, Abdominal Compartment Syndrome, Intraabdominal Hypertension, Cardiovascular Surgery
- Being tested
- Accuryn Monitoring System
- Medical subject headings
- Acute Kidney Injury, Intra-Abdominal Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Accuryn Monitoring SystemDevice
The Accuryn Monitoring System is a novel Foley catheter and monitoring device capable of detecting physiologic changes in vital signs via sensors within the catheter system. These data are captured non-invasively, continuously, and at a high frequency.
| Study group | Role | What they receive |
|---|---|---|
| Accuryn Monitoring System | Observational only (no intervention). Patients undergoing cardiovascular surgical intervention(s) monitored with the Accuryn Monitoring System (per standard of care) during their hospital stay. Receives: Device: Accuryn Monitoring System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urine Output (UO)
High accuracy Urine Output (mL/hour) while on a urinary catheter, and estimated UO while not on a urinary catheter
Measured: 30 days
Intra-Abdominal Pressure (IAP)
Intra-Abdominal Pressure (mmHg) trending while on a urinary catheter, as well as active measurements taken by clinician
Measured: 30 days
Temperature (T)
Temperature (degrees Celsius) trending during hospital stay
Measured: 30 days
Intraabdominal Hypertension (IAH)
Intra-abdominal pressure (IAP) above 12 mm Hg (timepoint and duration)
Measured: 30 days
Abdominal Compartment Syndrome (ACS)
Intra-abdominal pressure (IAP) above 20 mm Hg with new organ dysfunction or failure (timepoint and duration)
Measured: 30 days
Acute Kidney Injury (AKI)
% of patients diagnosed with AKI, and hospitalization day of diagnosis. AKI diagnosed per KDIGO criteria (Stage 1 to 3)
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2020
- Study start10 Jul 2017
- Primary completion6 Oct 2019
- Study completion5 Nov 2019
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.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
- Target duration
- 30 Days
Sponsor and investigators
- Lead sponsor
- Potrero Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Amit Prabhakar, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04585555
- Sponsor's protocol ID
- CRD-06-2963
- Status last verified
- Feb 2021
- First submitted
- 21 Aug 2020
- Last updated
- 4 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physiologic Signals and Signatures With the Accuryn Monitoring System - A Retrospective and Prospective Analysis (The Accuryn Registry)
- ClinicalTrials.gov ID
- NCT04585555
- Acronym / sponsor ID
- CRD-06-2963
- Conditions
- Acute Kidney Injury, Abdominal Compartment Syndrome, Intraabdominal Hypertension, Cardiovascular Surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Potrero MedicalIndustry (pharma, biotech, devices)
- Study start
- 10 Jul 2017 (actual)
- Primary completion
- 6 Oct 2019 (actual)
- Study completion
- 5 Nov 2019 (actual)
- First posted
- 14 Oct 2020 (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.
The Accuryn Registry Study is an open-ended, global, multi-center, retrospective and prospective, single-arm data collection study with an FDA cleared device. The target population are cardiovascular surgery patients. Physiologic data measurements will be collected from enrolled subjects using electronic medical records and data streams via the Accuryn Monitoring System.
Detailed description
The primary objective of the Accuryn Registry Study is to is to track and analyze changes in physiologic data streams using the Accuryn Monitoring System and correlate these changes to the occurrence of acute kidney injury (AKI) following cardiovascular surgery intervention(s).
The secondary objective is to determine the incidence of IAH and ACS in the cardiovascular surgery population and the correlation of these diagnoses to the diagnosis of AKI.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 30 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Accuryn Monitoring System | – | Device: Accuryn Monitoring SystemObservational only (no intervention). Patients undergoing cardiovascular surgical intervention(s) monitored with the Accuryn Monitoring System (per standard of care) during their hospital stay. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing cardiovascular surgical intervention(s) monitored with the Accuryn Monitoring System (per standard of care) during their hospital stay.
Key inclusion criteria (3 listed)
- Adult (age ≥ 18).
- Monitored on the Accuryn® Monitoring System during hospital stay.
- Patient is undergoing cardiovascular surgical intervention(s).
Key exclusion criteria (1 listed)
- 1. The patient is unsuitable for the study, in the opinion of the investigator. This may include vulnerable patient populations such as prisoners or those detained in a penal institution.
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 |
|---|---|---|
| Accuryn Monitoring SystemThe Accuryn Monitoring System is a novel Foley catheter and monitoring device capable of detecting physiologic changes in vital signs via sensors within the catheter system. These data are captured non-invasively, continuously, and at a high frequency. | Device | Accuryn Monitoring System |
Primary outcome
Urine Output (UO)
Time frame: 30 days
High accuracy Urine Output (mL/hour) while on a urinary catheter, and estimated UO while not on a urinary catheter
Intra-Abdominal Pressure (IAP)
Time frame: 30 days
Intra-Abdominal Pressure (mmHg) trending while on a urinary catheter, as well as active measurements taken by clinician
Temperature (T)
Time frame: 30 days
Temperature (degrees Celsius) trending during hospital stay
Intraabdominal Hypertension (IAH)
Time frame: 30 days
Intra-abdominal pressure (IAP) above 12 mm Hg (timepoint and duration)
Abdominal Compartment Syndrome (ACS)
Time frame: 30 days
Intra-abdominal pressure (IAP) above 20 mm Hg with new organ dysfunction or failure (timepoint and duration)
Acute Kidney Injury (AKI)
Time frame: 30 days
% of patients diagnosed with AKI, and hospitalization day of diagnosis. AKI diagnosed per KDIGO criteria (Stage 1 to 3)
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 4 Feb 2021.
- Individual participant dataSharing planned: Undecided
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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.
Amit Prabhakar, MD principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Kidney Injury and Abdominal Compartment Syndrome, run by Potrero Medical at 1 site 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 3 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 4 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
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?
Urine Output (UO) (time frame: 30 days). The study lists 6 primary outcomes in all. 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 4 Feb 2021; AzTrials last refreshed its copy on 8 Nov 2026.