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Point of Care Ultrasound Measurements of Perioperative Edema in Infants With Congenital Heart Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04151160
Recruitment Status : Recruiting
First Posted : November 5, 2019
Last Update Posted : June 4, 2020
Sponsor:
Collaborator:
MuscleSound
Information provided by (Responsible Party):
University of Colorado, Denver

Brief Summary:
Babies can be born with heart problems and sometimes need a heart surgery to fix the heart problem. Heart surgery can cause swelling from the build-up of extra fluid. Swelling can make it harder for babies to breath and has to be treated with medicine called diuretics. Swelling is hard to measure in babies, so it can be hard to know how much diuretic they need to treat the swelling. The investigators are looking for a better way to measure swelling in babies who have had heart surgery. Ultrasound uses sound waves to take pictures of the inside of the body. Ultrasound is used to take pictures of babies before they are born and to take pictures of their heart after they are born. New ultrasound software has been made from a company called MuscleSound that can quickly measure the amount of swelling in adults, usually in less than 2 minutes. This software has not yet been used to measure swelling in kids. This study plans to learn more about swelling in babies and will try to measure swelling in babies before and after heart surgery with the new ultrasound software. The study will also make the same measurements in babies who do not have heart disease to compare to babies having heart surgery.

Condition or disease Intervention/treatment
Congenital Heart Disease Edema Fluid Overload Diagnostic Test: Point of care ultrasound measurements

Detailed Description:

Congenital heart disease is the most common birth defect and occurs in ~8 per 1000 live births in the United States. Approximately 25% of these infants require surgery in the first year of life to repair or palliate their heart defect. Many cardiac surgeries require the use of cardiopulmonary bypass to maintain systemic blood flow and oxygen delivery during surgery. Cardiopulmonary bypass is not a natural process, and, as a result, contributes to post-operative physiologic derangements including ischemia-reperfusion injury, systemic inflammatory response, and subsequent fluid overload.

Fluid overload, in particular, is a common issue in children undergoing cardiac surgery, particularly in the immediate post-operative period. The rates of fluid overload following cardiothoracic surgery are high, reported between 31% and 100% in different studies depending on the method of assessment and the degree of fluid overload analyzed. Diaz et al demonstrated approximately 55% of children requiring mechanical ventilation or inotropic support in the intensive care unit developed fluid overload. Fluid overload is defined as a positive fluid balance and can occur extra or intravascularly. The buildup of excess extravascular fluid is also known as edema. The etiology of fluid overload and edema is multifactorial and includes fluid retention due neurohormonal pathway activation such as vasopressin and renin-angiotensin system, congestive heart failure, iatrogenic fluid administration, and capillary leak. Intravascular fluid overload can cause elevated central venous pressure, potentially leading to poor renal perfusion and subsequent acute kidney injury (AKI) while extravascular edema compromises abdominal and thoracic compliance and can make ventilation difficult. In the post-operative period, fluid overload has been associated with significant morbidity including AKI, longer mechanical ventilation dependence, prolonged length of stay, and increased mortality.

Unfortunately, management and treatment of fluid overload and edema are not standardized as it is currently difficult to accurately quantify the degree of fluid overload. Methods for monitoring fluid status include trending body weights, monitoring net fluid balance (intake versus output), trending central venous pressure, and physical exam findings. All of these current methods for monitoring fluid status can easily be confounded in the intensive care unit. A paucity of data exists regarding accurate methods of assessing edema in infants. Objective methods of evaluating fluid overload have been attempted, but are limited to measuring only intravascular volume, such as ultrasound of the jugular vein, or are difficult to apply clinically, such as skin bioelectric impedance. Additional research is needed to better understand and directly measure edema in infants.

Ultrasound of the skin is one possible method for quantifying extravascular fluid overload and edema through measurement of the thickness of skin and underlying subcutaneous layers. Ultrasound has previously been utilized in pediatric patients to diagnose skin and soft tissue infections, but there are no dedicated studies performed to solely measure edema. MuscleSound, an ultrasound technology company, has developed an automated software system to measure skin tissue structures, including edema, in adults. This technology has been studied in adults, however, it has not yet been trialed or validated in children. The ability to evaluate edema with a reliable, automated, non-invasive, bedside tool would provide objective measurements into a patient's fluid status. This tool would be of particular importance in infants with congenital heart disease who have many risk factors for fluid overload but whose fluid status can be difficult to appropriately assess.

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Using Point of Care Ultrasound to Measure Perioperative Edema in Infants With Congenital Heart Disease
Actual Study Start Date : January 13, 2020
Estimated Primary Completion Date : February 2021
Estimated Study Completion Date : February 2021

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Case Subjects
Infants with hemodynamically significant congenital heart disease.
Diagnostic Test: Point of care ultrasound measurements
i. Ultrasound images will be obtained using a commercial, high frequency, linear Philips ultrasound probe attached to small, portable tablet. This tablet will have the capability of transferring the saved images to the secure MuscleSound cloud-based server.

Control Subjects
Healthy infants with no heart disease or non-hemodynamically significant congenital heart disease.
Diagnostic Test: Point of care ultrasound measurements
i. Ultrasound images will be obtained using a commercial, high frequency, linear Philips ultrasound probe attached to small, portable tablet. This tablet will have the capability of transferring the saved images to the secure MuscleSound cloud-based server.




Primary Outcome Measures :
  1. Ultrasound Measurement of Edema [ Time Frame: Up to Post-Op Day 5 ]
    Depth (in millimeters) of edema from skin ultrasound measurements.


Secondary Outcome Measures :
  1. Change in Daily Weight [ Time Frame: Day 0, Day 1, Day 2, Day 3, Day 4, Day 5 ]
    Weight will be recorded in kilograms (kg)

  2. Daily Fluid Balance (intake and output) [ Time Frame: Up to Post-Op Day 5 ]
    Hourly fluid intake and output will be measured in milliliters (mL)

  3. CVP Measurements [ Time Frame: Up to Post-Op Day 5 ]
    Current central venous pressure (CVP) will be documented in millimeters of Mercury (mmHg) at the time of the each daily ultrasound

  4. Documentation of edema [ Time Frame: Up to Post-Op Day 5 ]
    Presence of edema documented in the Electronic Medical Record (EMR)

  5. Reports of pulmonary edema and/or pleural effusions on chest x-ray reports [ Time Frame: Up to Post-Op Day 5 ]
    Documentation of "pulmonary edema" and/or "pleural effusions". If pulmonary edema and/or pleural effusions are documented on chest x-ray, then this will be added to the study data collection form, including the documented severity (ranging from "minimal", "mild", "moderate", and "large")

  6. Daily diuretic dose [ Time Frame: Up to Post-Op Day 5 ]
    Total amount of diuretics given in the post-operative period (and day prior to surgery).The diuretic dose over each 24 hour post-operative period (from post-operative day 0 up to post-operative day 5) will be divided by the subject's weight in kilograms leading to a total daily diuretic dose in "mcg/kg/day" or "mg/kg/day".

  7. Daily positive pressure ventilation (invasive or non-invasive), [ Time Frame: Up to Post-Op Day 5 ]
    Documentation of mechanical ventilation, Continuous positive airway pressure (CPAP), Bilevel Positive Airway Pressure (BiPAP), Average volume-assured pressure support (AVAPS), and SiPAP. The number of days (rounding to the nearest half day) that a patient requires any of these forms of positive pressure ventilation will be documented.

  8. Length of mechanical ventilation (hours), [ Time Frame: Up to Post-Op Day 5 ]
    Documentation of mechanical ventilation, CPAP, BiPAP, AVAPS, and SiPAP. The hours that a patient requires mechanical ventilation in the post-operative period will be calculated and documented

  9. Intensive care unit length of stay (days) [ Time Frame: Up to Post-Op Day 5 ]
    The days spent in the intensive care unit in the post-operative period will be calculated and documented

  10. Development of Acute Kidney Injury (AKI) using the Acute Kidney Injury Network (AKIN) scoring system [ Time Frame: Up to Post-Op Day 5 ]
    The AKIN scale will be used to assess the presence and severity of acute kidney injury (AKI). The AKIN is a classification/staging system of acute kidney injury developed by the Acute Kidney Injury Network which uses changes in serum creatinine (SCr) and urine output to assess AKI. Stages of acute kidney injury are defined as 1, 2, or 3, with 3 indicating the most severe AKI.

  11. Post-operative mortality [ Time Frame: Up to 30 days Post-Op ]
    Death during their hospitalization after surgery or within 30 days in the post-operative period



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   up to 12 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Case subjects: Infants with hemodynamically significant congenital heart disease.

Control subjects: Healthy infants with no heart disease or non-hemodynamically significant congenital heart disease.

Criteria

Case Subjects:

Inclusion Criteria:

  • Age less than or equal to 12 months old at the time of enrollment
  • Known hemodynamically significant congenital heart disease
  • Undergoing surgery, with or without cardiopulmonary bypass, to repair or palliate their congenital heart defect

Exclusion Criteria:

  • Known renal dysfunction
  • Prematurity less than 36 weeks corrected gestational age

Control Subjects:

Inclusion Criteria:

  • Age less than or equal to 12 months old at the time of enrollment
  • No known heart disease OR presence of only non-hemodynamically significant congenital heart disease, including: tiny muscular ventricular septal defect, patent foramen ovale, peripheral pulmonary stenosis, normally functioning bicuspid aortic valve (no stenosis and no more than trivial insufficiency), and tiny patent ductus arteriosus

Exclusion Criteria:

  • History of hemodynamically significant congenital heart disease
  • History of surgery with general anesthesia
  • Known renal dysfunction
  • Prematurity less than 36 weeks corrected gestational age

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04151160


Contacts
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Contact: Jessica Persson, MD (330) 519-2525 jessica.persson@childrenscolorado.org

Locations
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United States, Colorado
Children's Hospital Colorado Recruiting
Aurora, Colorado, United States, 80045
Contact: Jessica Persson, MD    330-519-2525    jessica.persson@childrenscolorado.org   
Sponsors and Collaborators
University of Colorado, Denver
MuscleSound
Investigators
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Principal Investigator: Jessica Persson, MD University of Colorado, Denver
Study Director: Jesse Davidson, MD University of Colorado, Denver
Publications:
Benjamin EJ, Blaha MJ, Chiuve SE, Cushman M, Das SR, Deo R, de Ferranti SD, Floyd J, Fornage M, Gillespie C, Isasi CR, Jiménez MC, Jordan LC, Judd SE, Lackland D, Lichtman JH, Lisabeth L, Liu S, Longenecker CT, Mackey RH, Matsushita K, Mozaffarian D, Mussolino ME, Nasir K, Neumar RW, Palaniappan L, Pandey DK, Thiagarajan RR, Reeves MJ, Ritchey M, Rodriguez CJ, Roth GA, Rosamond WD, Sasson C, Towfighi A, Tsao CW, Turner MB, Virani SS, Voeks JH, Willey JZ, Wilkins JT, Wu JH, Alger HM, Wong SS, Muntner P; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart Disease and Stroke Statistics-2017 Update: A Report From the American Heart Association. Circulation. 2017 Mar 7;135(10):e146-e603. doi: 10.1161/CIR.0000000000000485. Epub 2017 Jan 25. Review. Erratum in: Circulation. 2017 Mar 7;135(10 ):e646. Circulation. 2017 Sep 5;136(10 ):e196.
Millan IS, Hill J and Wischmeyer PE. Measurement of skeletal muscle glycogen status in critically ill patients: a new approach in critical care monitoring. Critical Care. 2015;19:S141.

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Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT04151160    
Other Study ID Numbers: 19-1387
First Posted: November 5, 2019    Key Record Dates
Last Update Posted: June 4, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by University of Colorado, Denver:
MuscleSound
Additional relevant MeSH terms:
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Heart Diseases
Heart Defects, Congenital
Edema
Cardiovascular Diseases
Cardiovascular Abnormalities
Congenital Abnormalities