Agitated Saline, Albumin, or Propofol-albumin Mixture for Enhanced Contrast in TEE Examinations

September 23, 2019 updated by: Swapnil Khoche, University of California, San Diego

The Use of Agitated Saline, Albumin, or a Propofol-albumin Mixture for Enhanced Contrast in Bubble Studies During Transesophageal Echocardiographic 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, 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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 the current standard of care contrast agent, agitated saline. The study will take place in the Operating Rooms (OR) at the UCSD Sulpizio Cardiovascular Center. The TEE studies will be reviewed by UCSD Anesthesiology or Cardiology faculty who are credentialed to read and interpret echocardiographic studies.

The study population will consist of 20 English-speaking patients and all will receive two doses of contrast, namely agitated albumin or propofol and albumin mixture, undergoing cardiac surgery who require TEE. Each patient will undergo qualitative review by 10 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. The multiple reviewers per patient will increase the power of the study (~200 studies). Each patient will receive three bubble studies using 10 ml of agitated contrast agent as named above. The order in which each contrast agent is utilized, as well as the experimental contrast agent, is randomized and the interpreting physician is blinded to this information. Agitated saline (AS) alone will be used as a (third dose) control for each patient, which is the current standard contrast agent for TEE bubble studies. The other bubble studies will use an experimental agitated contrast agent, either a mixture of 7 mL albumin and 3 mL propofol (10 mg/ml) or 10 mL albumin (human). Saline and albumin 5% are intravenous fluids FDA approved for the use in restoration and maintenance of circulating of blood volume. Propofol is FDA approved for the use in induction or maintenance of general anesthesia.

The anesthesia care team, as per the standard care during UCSD cardiac surgical procedures, will place a TEE probe after induction of general anesthesia and endotracheal intubation. During the initial TEE exam, a bicaval view will be obtained. Both the order and type of experimental agitated contrast agent will be randomized and blinded to the sonographer and reviewer. A 20 beat loop will be recorded for each bubble study. Hemodynamic variables prior to injection of contrast agent; and 30 seconds, 1 minute and 2 minutes after injection are monitored and recorded. All recorded data will be anonymized prior to review. TEE is standard of care and routinely used in the care of cardiac surgery patients and is not performed solely for this study.

All anesthetic, surgical and medical interventions will be chosen and carried out by the surgical and anesthesia teams, including those involving invasive monitor placement, fluid administration, ventilator management and patient positioning.

Appropriate statistical analysis will be utilized to evaluate the difference in contrast enhancement in the saline only, albumin, and albumin and propofol groups.

The results of the study will be published in the peer-reviewed medical literature.

Study Type

Interventional

Enrollment (Actual)

17

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • La Jolla, California, United States, 92037
        • UC San Diego Sulpizio Cardiovascular Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • cardiac surgical patients requiring a transesophageal echocardiogram (TEE)

Exclusion Criteria:

  • allergy to propofol
  • inability to place a TEE probe
  • inability to obtain a TEE bicaval image
  • known right to left intracardiac shunt
  • pt refusal to accept human blood products including albumin
  • pt refusal to participate in study
  • vulnerable patients (pregnant women, prisoners, cognitively impaired, or institutionalized)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Agitated Normal Saline
Agitated saline is the current standard of care contrast agent used for bubble studies. 10 mL of agitated normal saline will be used for the bubble study.
Drug: normal saline
10 mL of normal saline agitated prior to IV administration
Other Names:
  • sodium chloride
Active Comparator: Albumin only
10 mL of agitated 5% albumin will be used for the bubbly study.
Drug: human albumin
10 mL of 5% albumin agitated prior to IV administration
Experimental: Albumin and Propofol
7 mL of 5% albumin and 3 mL of propofol (10 mg/mL) will be agitated together and used for the bubble study.
Drug: human albumin and propofol
7 mL of 5% albumin mixed with 3 mL of propofol (10 mg/mL) agitated together prior to IV administration
Other Names:
  • Diprivan

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Qualitative enhancement in right atrial opacification during intraoperative TEE bubble studies
Time Frame: 6 months
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.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Diego

Investigators

  • Principal Investigator: Swapnil Khoche, MD, University of California, San Diego
  • Study Director: Ryan YS Suda, MD, University of California, San Diego

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2016

Primary Completion (Actual)

June 1, 2017

Study Completion (Actual)

September 1, 2017

Study Registration Dates

First Submitted

November 19, 2015

First Submitted That Met QC Criteria

November 23, 2015

First Posted (Estimate)

November 24, 2015

Study Record Updates

Last Update Posted (Actual)

September 25, 2019

Last Update Submitted That Met QC Criteria

September 23, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 151360

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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