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NCT02613052 · ClinicalTrials.gov registry record · NA
Agitated Saline, Albumin, or Propofol-albumin Mixture for Enhanced Contrast in TEE Examinations
A NA study of Transesophageal Echocardiography Contrast Agents, sponsored by University of California, San Diego.
- Completed
- Registry status
- NA
- Development phase
- 17
- Enrollment target
- 1
- Study location
NCT02613052: Completed NA study of Transesophageal Echocardiography Contrast Agents, sponsored by University of California, San Diego.
NCT02613052 is a NA study of Transesophageal Echocardiography Contrast Agents that has completed, run by University of California, San Diego. The registered enrollment target is 17 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02613052, a NA study of Transesophageal Echocardiography Contrast Agents, has completed, sponsored by University of California, San Diego.
- COMPLETED
- Registry status
- NA
- Development phase
- 17 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a prospective, randomized, controlled study to determine if albumin and propofol or albumin only will provide superior qualitative contrast enhancement during TEE bubble studies compared to agitated saline. Each patient will receive three randomized bubble studies (agitated saline, albumin, and albumin and propofol) using 10 ml of agitated contrast agent. The albumin and propofol mixture will consist of 7 mL of 5% albumin plus 3 mL of propofol (10 mg/mL). Each patient will undergo qualitative review of all 3 bubble studies by 10 different anesthesiologists and/or cardiologists credentialed to read echocardiographic studies at the time of the surgical procedure, and also with retrospective review of the echo video (\~200 studies). A bicaval view will be obtained to record a 20 beat loop for each bubble study. Hemodynamic variables prior to injection of contrast agent; and 30 seconds, 1 minute and 2 minutes after injection will be monitored and recorded.
Primary Outcome
Number of participants with qualitatively enhanced right atrial opacification with albumin or albumin and propofol mixture compared to standard of care agitated normal saline, during TEE bubble studies using the bicaval view.
Conditions Studied
Interventions
- DRUG normal saline
- DRUG human albumin
- DRUG human albumin and propofol
Study Locations (1)
California
- UC San Diego Sulpizio Cardiovascular Center - La Jolla
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2016-01 |
| Est. Completion | 2017-09 |
| Phase | NA |
What the finished NCT02613052 record still lists
NCT02613052 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 17 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 1 condition, with Transesophageal Echocardiography Contrast Agents appearing as the primary indexed condition, and to 3 interventions - of which normal saline is the first listed.
NCT02613052 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT02613052 about?
NCT02613052 is a clinical study titled "Agitated Saline, Albumin, or Propofol-albumin Mixture for Enhanced Contrast in TEE Examinations". This is a prospective, randomized, controlled study to determine if albumin and propofol or albumin only will provide superior qualitative contrast enhancement during TEE bubble studies compared to agitated saline. Each patient will receive three randomized bubble studies (agitated saline, albumin, ...
What is the current status of trial NCT02613052?
This trial is currently completed. It is a NA study. The enrollment target is 17 participants. The study started on 2016-01. Estimated completion is 2017-09.
What conditions does trial NCT02613052 study?
This clinical trial studies the following conditions: Transesophageal Echocardiography Contrast Agents.
What interventions are being tested in trial NCT02613052?
The interventions under investigation include: normal saline (DRUG), human albumin (DRUG), human albumin and propofol (DRUG).
Who is sponsoring clinical trial NCT02613052?
This trial is sponsored by University of California, San Diego, which has 775 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02613052 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02613052's enrollment target sits among peer trials
17 1871st of 2000 higher than 130 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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