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

NCT02613052 | Completed

• 1 other identifier: 151360
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Transesophageal Echocardiography Contrast Agents

Outcome Measures

Primary Outcomes (1)

• Qualitative enhancement in right atrial opacification during intraoperative TEE bubble studies

  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

Study Arms (3)

Agitated Normal Saline

PLACEBO COMPARATOR

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

Albumin only

ACTIVE COMPARATOR

10 mL of agitated 5% albumin will be used for the bubbly study.

Drug: human albumin

Albumin and Propofol

EXPERIMENTAL

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

Interventions

normal saline DRUG

10 mL of normal saline agitated prior to IV administration

Also known as: sodium chloride

Agitated Normal Saline

human albumin DRUG

10 mL of 5% albumin agitated prior to IV administration

Albumin only

human albumin and propofol DRUG

7 mL of 5% albumin mixed with 3 mL of propofol (10 mg/mL) agitated together prior to IV administration

Also known as: Diprivan

Albumin and Propofol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• cardiac surgical patients requiring a transesophageal echocardiogram (TEE)

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of California, San Diego: lead

Study Sites (1)

UC San Diego Sulpizio Cardiovascular Center

La Jolla, California, 92037, United States

Location

Related Publications (13)

• Meerbaum S. Introduction and general background. In: Myocardial Contrast Two-Dimensional Echocardiography, Meerbaum S, Meltzer R (Eds), Kluwer Academic Publishers, Boston 1989. p.2

  BACKGROUND

• Stewart MJ. Contrast echocardiography. Heart. 2003 Mar;89(3):342-8. doi: 10.1136/heart.89.3.342. No abstract available.

  PMID: 12591856 BACKGROUND

• Attaran RR, Ata I, Kudithipudi V, Foster L, Sorrell VL. Protocol for optimal detection and exclusion of a patent foramen ovale using transthoracic echocardiography with agitated saline microbubbles. Echocardiography. 2006 Aug;23(7):616-22. doi: 10.1111/j.1540-8175.2006.00272.x.

  PMID: 16911341 BACKGROUND

• Unger EC, Porter T, Culp W, Labell R, Matsunaga T, Zutshi R. Therapeutic applications of lipid-coated microbubbles. Adv Drug Deliv Rev. 2004 May 7;56(9):1291-314. doi: 10.1016/j.addr.2003.12.006.

  PMID: 15109770 BACKGROUND

• Mulvagh SL, Rakowski H, Vannan MA, Abdelmoneim SS, Becher H, Bierig SM, Burns PN, Castello R, Coon PD, Hagen ME, Jollis JG, Kimball TR, Kitzman DW, Kronzon I, Labovitz AJ, Lang RM, Mathew J, Moir WS, Nagueh SF, Pearlman AS, Perez JE, Porter TR, Rosenbloom J, Strachan GM, Thanigaraj S, Wei K, Woo A, Yu EH, Zoghbi WA; American Society of Echocardiography. American Society of Echocardiography Consensus Statement on the Clinical Applications of Ultrasonic Contrast Agents in Echocardiography. J Am Soc Echocardiogr. 2008 Nov;21(11):1179-201; quiz 1281. doi: 10.1016/j.echo.2008.09.009.

  PMID: 18992671 BACKGROUND

• Porter TR, Abdelmoneim S, Belcik JT, McCulloch ML, Mulvagh SL, Olson JJ, Porcelli C, Tsutsui JM, Wei K. Guidelines for the cardiac sonographer in the performance of contrast echocardiography: a focused update from the American Society of Echocardiography. J Am Soc Echocardiogr. 2014 Aug;27(8):797-810. doi: 10.1016/j.echo.2014.05.011. No abstract available.

  PMID: 25085408 BACKGROUND

• Shapiro JR, Reisner SA, Lichtenberg GS, Meltzer RS. Intravenous contrast echocardiography with use of sonicated albumin in humans: systolic disappearance of left ventricular contrast after transpulmonary transmission. J Am Coll Cardiol. 1990 Dec;16(7):1603-7. doi: 10.1016/0735-1097(90)90308-c.

  PMID: 2254545 BACKGROUND

• Davison P, Clift PF, Steeds RP. The role of echocardiography in diagnosis, monitoring closure and post-procedural assessment of patent foramen ovale. Eur J Echocardiogr. 2010 Dec;11(10):i27-34. doi: 10.1093/ejechocard/jeq120.

  PMID: 21078836 BACKGROUND

• Baker MT, Naguib M. Propofol: the challenges of formulation. Anesthesiology. 2005 Oct;103(4):860-76. doi: 10.1097/00000542-200510000-00026.

  PMID: 16192780 BACKGROUND

• de Jong N, Emmer M, van Wamel A, Versluis M. Ultrasonic characterization of ultrasound contrast agents. Med Biol Eng Comput. 2009 Aug;47(8):861-73. doi: 10.1007/s11517-009-0497-1. Epub 2009 May 26.

  PMID: 19468770 BACKGROUND

• Kitzman DW, Goldman ME, Gillam LD, Cohen JL, Aurigemma GP, Gottdiener JS. Efficacy and safety of the novel ultrasound contrast agent perflutren (definity) in patients with suboptimal baseline left ventricular echocardiographic images. Am J Cardiol. 2000 Sep 15;86(6):669-74. doi: 10.1016/s0002-9149(00)01050-x.

  PMID: 10980221 BACKGROUND

• Dewhirst E, et al. The Use of a Propofol-Saline Mixture for Enhanced Contrast in Bubble Studies During Echocardiographic Examinations. Society of Pediatric Anesthesia Meeting (Winter 2012).

  BACKGROUND

• Geny B, Mettauer B, Muan B, Bischoff P, Epailly E, Piquard F, Eisenmann B, Haberey P. Safety and efficacy of a new transpulmonary echo contrast agent in echocardiographic studies in patients. J Am Coll Cardiol. 1993 Oct;22(4):1193-8. doi: 10.1016/0735-1097(93)90437-6.

  PMID: 8409060 BACKGROUND

MeSH Terms

Interventions

Saline Solution; Sodium Chloride; Serum Albumin, Human; Propofol

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Serum Albumin; Albumins; Proteins; Amino Acids, Peptides, and Proteins; Blood Proteins; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Swapnil Khoche, MD

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

• Ryan YS Suda, MD

  University of California, San Diego

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistand Clinical Professor

Study Record Dates

• First Submitted: November 19, 2015
• First Posted: November 24, 2015
• Study Start: January 1, 2016
• Primary Completion: June 1, 2017
• Study Completion: September 1, 2017
• Last Updated: September 25, 2019

Record last verified: 2019-09

Locations

US (1)