An observational study in Congenital Heart Disease, Edema and Fluid Overload, sponsored by University of Colorado, Denver. Completed at 1 site in United States. Open to participants aged 0 Days to 12 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-05-10.
Sponsored by University of Colorado, Denver · Observational
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.
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.
3,639 studies on the registry are indexed under Heart Diseases; 461 are open to participants now.
This study's enrollment of 72 is below the median of 294 across 1,241 observational studies indexed under Heart Diseases.
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Case subjects: Infants with hemodynamically significant congenital heart disease.
Control subjects: Healthy infants with no heart disease or non-hemodynamically significant congenital heart disease.
Case Subjects:
Inclusion Criteria:
Exclusion Criteria:
Control Subjects:
Inclusion Criteria:
Exclusion Criteria:
Infants with hemodynamically significant congenital heart disease.
Diagnostic Test: Point of care ultrasound measurements
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.
Ultrasound Measurement of Edema
Depth (in millimeters) of edema from skin ultrasound measurements.
Time frame: Up to Post-Op Day 5
Change in Daily Weight
Weight will be recorded in kilograms (kg)
Time frame: Day 0, Day 1, Day 2, Day 3, Day 4, Day 5
Daily Fluid Balance (intake and output)
Hourly fluid intake and output will be measured in milliliters (mL)
Time frame: Up to Post-Op Day 5
CVP Measurements
Current central venous pressure (CVP) will be documented in millimeters of Mercury (mmHg) at the time of the each daily ultrasound
Time frame: Up to Post-Op Day 5
Documentation of edema
Presence of edema documented in the Electronic Medical Record (EMR)
Time frame: Up to Post-Op Day 5
Reports of pulmonary edema and/or pleural effusions on chest x-ray reports
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")
Time frame: Up to Post-Op Day 5
Daily diuretic dose
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".
Time frame: Up to Post-Op Day 5
Daily positive pressure ventilation (invasive or non-invasive),
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.
Time frame: Up to Post-Op Day 5
Length of mechanical ventilation (hours),
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
Time frame: Up to Post-Op Day 5
Intensive care unit length of stay (days)
The days spent in the intensive care unit in the post-operative period will be calculated and documented
Time frame: Up to Post-Op Day 5
Development of Acute Kidney Injury (AKI) using the Acute Kidney Injury Network (AKIN) scoring system
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.
Time frame: Up to Post-Op Day 5
Post-operative mortality
Death during their hospitalization after surgery or within 30 days in the post-operative period
Time frame: Up to 30 days Post-Op
Plan to share: No
This study is completed, as verified in May 2023. You cannot join it, but the record below documents what was studied.
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University of Colorado, Denver