- Study Focus: Renal Retention of Lipid MicrobubblesNCT01647464
Renal Retention of Microbubbles
An observational study of - Study Focus: Renal Retention of Lipid Microbubbles, run by Oregon Health and Science University at 1 site in United States.
Trial summary
Flank pain has been reported with ultrasound (US) contrast agents. The purpose of this study is to determine whether there is retention of ultrasound contrast agents in the renal microcirculation, which has been described in mice. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- - Study Focus: Renal Retention of Lipid Microbubbles
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2012to Oct 2012
- Phase
- Observational
- 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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing contrast echocardoigraphy
Who may be able to join
- Undergoing clinically indicated contrast echo
- adequate renal ultrasound images
Who cannot join
- chronic inflammatory disease
- known kidney disease
- immunomodulatory therapy
Trial locations and contacts
1 site in 1 country.
United States1 site
Oregon Health & Science University
Portland, Oregon, 97239
About this study
Official title: Study of Whether There is Renal Retention of Lipid Microbubble Ultrasound Contrast Agents
Flank pain has been reported with ultrasound (US) contrast agents. The purpose of this study is to determine whether there is retention of ultrasound contrast agents in the renal microcirculation, which has been described in mice.
Read the detailed description
In this study patients undergoing clinically indicated contrast echocardiography will have renal ultrasound performed 10 minutes after completion of contrast infusion to determine the presence and location of renal retention of lipid microbubbles.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Contrast administration | Patients undergoing contrast-enhanced echo. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Renal Video Intensity Units
Video intensity units in the kidney 10 min after completion of a clinically indicated contrast echocardiography study.
Measured: 10 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2012 (estimated)
- Study startJul 2012
- Primary completionOct 2012
- Study completionOct 2012
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.
- Other trials for - Study Focus: Renal Retention of Lipid MicrobubblesStudies 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
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jonathan R. Lindner, MD, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01647464
- Sponsor's protocol ID
- MBretention
- Status last verified
- Mar 2016
- First submitted
- 19 Jul 2012
- Last updated
- 28 Apr 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Whether There is Renal Retention of Lipid Microbubble Ultrasound Contrast Agents
- ClinicalTrials.gov ID
- NCT01647464
- Acronym / sponsor ID
- MBretention
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 23 Jul 2012 (estimated)
- Results
- Posted 28 Apr 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Flank pain has been reported with ultrasound (US) contrast agents. The purpose of this study is to determine whether there is retention of ultrasound contrast agents in the renal microcirculation, which has been described in mice.
Detailed description
In this study patients undergoing clinically indicated contrast echocardiography will have renal ultrasound performed 10 minutes after completion of contrast infusion to determine the presence and location of renal retention of lipid microbubbles.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Contrast administration | – | –Patients undergoing contrast-enhanced echo. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing contrast echocardoigraphy
Key inclusion criteria (2 listed)
- Undergoing clinically indicated contrast echo
- adequate renal ultrasound images
Key exclusion criteria (3 listed)
- chronic inflammatory disease
- known kidney disease
- immunomodulatory therapy
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
Renal Video Intensity Units
Time frame: 10 min
Video intensity units in the kidney 10 min after completion of a clinically indicated contrast echocardiography study.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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.
The record lists no contact. Use the official record to reach the sponsor.
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 - Study Focus: Renal Retention of Lipid Microbubbles, run by Oregon Health and Science University 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 3 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 28 Apr 2016. 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?
Yes. Results are posted in the registry (first posted 28 Apr 2016). 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?
Renal Video Intensity Units (time frame: 10 min). 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 28 Apr 2016.