Clinical trial NCT04151160: Point of Care Ultrasound Measurements of Perioperative Edema in Infants With Congenital Heart Disease
Official title: Using Point of Care Ultrasound to Measure Perioperative Edema in Infants With Congenital Heart Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Congenital Heart Disease
Edema
Fluid Overload
Keywords: MuscleSound
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: MuscleSound
First posted: 2019-11-05
Enrollment: 72
Sex: ALL
Minimum age (years): 0
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility 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

Primary outcomes:
measure: Ultrasound Measurement of Edema
timeFrame: Up to Post-Op Day 5
Secondary outcomes:
measure: Change in Daily Weight
timeFrame: Day 0, Day 1, Day 2, Day 3, Day 4, Day 5
measure: Daily Fluid Balance (intake and output)
timeFrame: Up to Post-Op Day 5
measure: CVP Measurements
timeFrame: Up to Post-Op Day 5
measure: Documentation of edema
timeFrame: Up to Post-Op Day 5
measure: Reports of pulmonary edema and/or pleural effusions on chest x-ray reports
timeFrame: Up to Post-Op Day 5
measure: Daily diuretic dose
timeFrame: Up to Post-Op Day 5
measure: Daily positive pressure ventilation (invasive or non-invasive),
timeFrame: Up to Post-Op Day 5
measure: Length of mechanical ventilation (hours),
timeFrame: Up to Post-Op Day 5
measure: Intensive care unit length of stay (days)
timeFrame: Up to Post-Op Day 5
measure: Development of Acute Kidney Injury (AKI) using the Acute Kidney Injury Network (AKIN) scoring system
timeFrame: Up to Post-Op Day 5
measure: Post-operative mortality
timeFrame: Up to 30 days Post-Op
Other outcomes:
Locations:
city: Aurora
country: United States
facility: Children's Hospital Colorado
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Jessica Persson, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Colorado, Denver
name: Jesse Davidson, MD
role: STUDY_DIRECTOR
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