Cardiac Surgical ProceduresNCT02580292
Diagnostic Accuracy of Doppler Resistive Indices for Early Diagnosis of Acute Kidney Injury .
An observational study of Cardiac Surgical Procedures, run by University of Michigan at 1 site in United States.
Trial summary
To determine if ultrasound measurement of renal and carotid arterial resistive indices are associated with post-cardiac surgery acute kidney injury. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Surgical Procedures
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2015to 25 Apr 2024
- 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: Adult patients undergoing cardiac surgery
Who may be able to join
- adult patients >= 18 years
- undergoing cardiac surgery with cardiopulmonary bypass and transesophageal echocardiography (TEE) probe placement
Who cannot join
- chronic kidney diseases (estimated GFR < 60 ml/min/1.73m2)
- prior carotid endarterectomy
- known carotid artery stenosis of 50% or greater
- dissection or aneurysm involving renal or carotid arteries
- scheduled aortic or aortic valve surgery
- heart transplant
- intraaortic balloon pump, ventricular assist device, or exctracorporeal membrane oxygenation support.
Trial locations and contacts
1 site in 1 country.
United States1 site
Cardiovascular Center - University of Michigan
Ann Arbor, Michigan, 48109
About this study
Official title: Diagnostic Accuracy of Renal, Carotid, and Aortic Doppler Resistive Indices for Early Diagnosis of Acute Kidney Injury Following Cardiopulmonary Bypass Surgery.
To determine if ultrasound measurement of renal and carotid arterial resistive indices are associated with post-cardiac surgery acute kidney injury.
Read the detailed description
To determine if ultrasound measurement of renal and carotid arterial resistive indices are associated with post-cardiac surgery acute kidney injury.
- Conditions
- Cardiac Surgical Procedures
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute kidney injury - Lassnigg grade-minimal
Based on change in creatinine
Measured: 2nd postoperative day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2015 (estimated)
- Study startOct 2015
- Primary completion25 Apr 2024
- Study completion25 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac Surgical ProceduresStudies of the same condition, open and under way.
- More trials run by University of MichiganThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Milo Engoren, University of Michigan
- Investigators
- Milo Engoren, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02580292
- Sponsor's protocol ID
- 1
- Status last verified
- Nov 2024
- First submitted
- 17 Oct 2015
- Last updated
- 12 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Accuracy of Renal, Carotid, and Aortic Doppler Resistive Indices for Early Diagnosis of Acute Kidney Injury Following Cardiopulmonary Bypass Surgery.
- ClinicalTrials.gov ID
- NCT02580292
- Acronym / sponsor ID
- 1
- Conditions
- Cardiac Surgical Procedures
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- 25 Apr 2024 (actual)
- Study completion
- 25 Apr 2024 (actual)
- First posted
- 20 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.
To determine if ultrasound measurement of renal and carotid arterial resistive indices are associated with post-cardiac surgery acute kidney injury.
Detailed description
To determine if ultrasound measurement of renal and carotid arterial resistive indices are associated with post-cardiac surgery acute kidney injury.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients undergoing cardiac surgery
Key inclusion criteria (2 listed)
- adult patients >= 18 years
- undergoing cardiac surgery with cardiopulmonary bypass and transesophageal echocardiography (TEE) probe placement
Key exclusion criteria (7 listed)
- chronic kidney diseases (estimated GFR < 60 ml/min/1.73m2)
- prior carotid endarterectomy
- known carotid artery stenosis of 50% or greater
- dissection or aneurysm involving renal or carotid arteries
- scheduled aortic or aortic valve surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Acute kidney injury - Lassnigg grade-minimal
Time frame: 2nd postoperative day
Based on change in creatinine
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 12 Nov 2024.
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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.
Milo Engoren principal investigator
University of Michigan
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 Cardiac Surgical Procedures, run by University of Michigan 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 2 inclusion and 7 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 12 Nov 2024. 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?
Acute kidney injury - Lassnigg grade-minimal (time frame: 2nd postoperative day). 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 12 Nov 2024.