Acute Kidney InjuryNCT02578173
Evaluation of a Novel Method of Contrast Volume Quantification - AVERT PLUS 2.0
An observational study of Acute Kidney Injury, run by Anand Prasad.
Trial summary
Purpose: To evaluate the accuracy of the AVERT PLUS to monitor contrast volume used during angiographic procedures. This will be a first in man prospective observational study of the accuracy of this system to quantify contrast volume used during clinically indicated angiography in the cardiac catheterization… 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?
- AVERT PLUS
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Oct 2015to Mar 2016
- 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 with cardiovascular disease who are undergoing clinically indicated coronary or peripheral angiography
Who may be able to join
- Patients undergoing clinically indicated coronary or peripheral angiography
Who cannot join
- None
About this study
Purpose: To evaluate the accuracy of the AVERT PLUS to monitor contrast volume used during angiographic procedures. This will be a first in man prospective observational study of the accuracy of this system to quantify contrast volume used during clinically indicated angiography in the cardiac catheterization laboratory.
Read the detailed description
Research Design:
The AVERT PLUS is an FDA 510K cleared device which consists of 1) a contrast delivery modulator designed to reduce unnecessary contract dye delivery to the patient during angiography (coronary or peripheral) and 2) a concomitant contrast monitoring system to precisely measure contrast volume delivered to the patient. This will be a first in man prospective observational study of the accuracy of this system to quantify contrast volume used during clinically indicated angiography in the cardiac catheterization laboratory.
- Conditions
- Acute Kidney Injury
- Being tested
- AVERT PLUS
- 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.
AVERT PLUSDevice
| Study group | Role | What they receive |
|---|---|---|
| AVERT PLUS | The AVERT PLUS will be used on the first 10 patients enrolled in the study. The AVERT PLUS is a contrast monitoring system which is used to precisely measure the volume of contrast delivered to the patient. Receives: Device: AVERT PLUS | |
| Non device group | The second group of 10 patients will undergo the scheduled angiography using the standard method of measuring contrast dye delivery. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Observational study of the accuracy of the AVERT PLUS CM system to quantify contrast volume during a clinically indicated procedure.
The fluid volume of contrast media used during the angiography procedure will be measured in milliliters.
Measured: The total volume of contrast received by the subject will be measured at the conclusion of the angiography procedure, procedure duration from 30 minutes to 4 hours dependent on patient's clinical status; no further measurements thereafter.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2015 (estimated)
- Study startOct 2015
- Primary completionMar 2016
- Study completionMar 2016
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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Anand Prasad
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Anand Prasad, The University of Texas Health Science Center at San Antonio
- Investigators
- Michele Shepard, Study director, Osprey Medical, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02578173
- Sponsor's protocol ID
- HSC20150682H
- Status last verified
- Jun 2016
- First submitted
- 10 Oct 2015
- Last updated
- 21 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Novel Method of Contrast Volume Quantification - AVERT PLUS 2.0
- ClinicalTrials.gov ID
- NCT02578173
- Acronym / sponsor ID
- HSC20150682H
- Conditions
- Acute Kidney Injury
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Anand PrasadUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 16 Oct 2015 (estimated)
- 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.
Purpose: To evaluate the accuracy of the AVERT PLUS to monitor contrast volume used during angiographic procedures. This will be a first in man prospective observational study of the accuracy of this system to quantify contrast volume used during clinically indicated angiography in the cardiac catheterization laboratory.
Detailed description
Research Design:
The AVERT PLUS is an FDA 510K cleared device which consists of 1) a contrast delivery modulator designed to reduce unnecessary contract dye delivery to the patient during angiography (coronary or peripheral) and 2) a concomitant contrast monitoring system to precisely measure contrast volume delivered to the patient. This will be a first in man prospective observational study of the accuracy of this system to quantify contrast volume used during clinically indicated angiography in the cardiac catheterization laboratory.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AVERT PLUS | – | Device: AVERT PLUSThe AVERT PLUS will be used on the first 10 patients enrolled in the study. The AVERT PLUS is a contrast monitoring system which is used to precisely measure the volume of contrast delivered to the patient. |
| Non device group | – | –The second group of 10 patients will undergo the scheduled angiography using the standard method of measuring contrast dye delivery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with cardiovascular disease who are undergoing clinically indicated coronary or peripheral angiography
Key inclusion criteria (1 listed)
- Patients undergoing clinically indicated coronary or peripheral angiography
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| AVERT PLUS | Device | AVERT PLUS |
Primary outcome
Observational study of the accuracy of the AVERT PLUS CM system to quantify contrast volume during a clinically indicated procedure.
Time frame: The total volume of contrast received by the subject will be measured at the conclusion of the angiography procedure, procedure duration from 30 minutes to 4 hours dependent on patient's clinical status; no further measurements thereafter.
The fluid volume of contrast media used during the angiography procedure will be measured in milliliters.
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 21 Jun 2016.
Related trials for Acute Kidney Injury
Not yet recruiting
Vitamin C for Acute Kidney Injury in ACLF With Septic Shock: A Randomized Controlled Trial
Acute-on-Chronic Liver Failure (ACLF)
Not yet recruiting
Early Biomarker Kidney Injury Assessment After Acumen Directed Fluid Management in Cardiac Surgery
Renal Injury, Acute Kidney Injury
Recruiting
Acute Kidney Injury and Ultra-endurance Running
AKI (Acute Kidney Injury) Due to Trauma
Recruiting
WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency Department
Acute Hypoxic Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS)
Not yet recruitingObservational study
Diastolic Shock Index for Predicting Hemodynamic Instability During Continuous Renal Replacement Therapy
Acute Kidney Injury, Hypotension (MeSH: D007022)
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.
Michele Shepard study director
Osprey Medical, Inc
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Kidney Injury, run by Anand Prasad.
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 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 21 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Observational study of the accuracy of the AVERT PLUS CM system to quantify contrast volume during a clinically indicated procedure. (time frame: The total volume of contrast received by the subject will be measured at the conclusion of the angiography procedure, procedure duration from 30 minutes to 4 hours dependent on patient's clinical status; no further measurements thereafter.). 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 21 Jun 2016.