Malformations of the heart are common; 1.35 million infants are born each year with congenital heart disease. Many of these defects carry a considerable threat to the individual's quality of life as well as survival. Along with focused medical management, surgical repair remains a standard of care for more than 25,000 infants and children each year in the United States and Canada. The care of individuals with congenital heart disease is highly complex and has significant risks of morbidity and mortality. Most cardiac operations require the use of cardiopulmonary bypass (CPB, also known as the heart-lung machine) to safely access the inner chambers of the heart. CPB itself has been well documented to cause significant inflammation and hemodilution as the individual's blood is passed through a foreign circuit. This inflammatory response can lead to fluid overload, distributive shock and potential end-organ dysfunction in the heart, lungs, kidneys, brain, liver or bowels. These organ dysfunctions may culminate in post-operative low cardiac output syndrome (LCOS), prolonged ventilation time, prolonged intensive care unit (ICU) stay and can contribute to mortality. Dampening the inflammatory response from CPB has been a focus of research interest for years. Intra-operative ultrafiltration has been used to remove excess fluids and filter off inflammatory cytokines during cardiac operations. Over 90% of children's heart centers in the world utilize some form of ultrafiltration (mostly some form of modified ultrafiltration), but there are wide variations in published ultrafiltration protocols (none of which are combination SBUF-SMUF in children). Ultimately, this project seeks to provide high-quality evidence that the immunologic and clinical effects of combination SBUF-SMUF are rate dependent. Therefore, a randomized study directly comparing a high-exchange SBUF-SMUF (60ml/kg/hr) and a low-exchange SBUF-SMUF (6ml/kg/hr) can identify which is the optimal ultrafiltration protocol to enhance post-operative clinical outcomes for this patient population. The expected data and results could be immediately applicable to improve recovery after heart surgery for infants and children across Canada and the rest of the world at large.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
104
Ultrafiltration is used during cardiac surgery with cardiopulmonary bypass to remove both fluid and small molecules such as inflammatory cytokines from the patient's circulation.
IWK Health Centre
Halifax, Nova Scotia, Canada
Peak Vasoactive-Ventilation Renal Score
Time frame: Up to 5 days
Vasoactive Inotrope Score
Taken in time series at ICU admission, 0, 12, 24, 36, 48, 72, 96 and 120 hours.
Time frame: Up to 5 days
Ventilation Index
Taken in time series at ICU admission, 0, 12, 24, 36, 48, 72, 96 and 120 hours.
Time frame: Up to 5 days
Oxygenation Index
Taken in time series at ICU admission, 0, 12, 24, 36, 48, 72, 96 and 120 hours.
Time frame: Up to 5 days
Ventilation Time
Time frame: Up to 28 days
Ventilator Free Days
Time frame: Up to 28 days
Low Cardiac Output Syndrome
Defined by any one of the following within the first 72 post-operative hours: * Lactate \> 4mM with oxygen extraction \>35% (SaO2 - ScvO2/ SaO2) * VIS \> 15.0 with oxygen extraction \>35% (SaO2 - ScvO2/ SaO2) * Mechanical circulatory support requirement
Time frame: Up to 3 days
Vasoplegic Shock
Defined by any one of the following with the first 72 post-operative hours: * Lactate \> 4mM with oxygen extraction \<25% (SaO2 - ScvO2/ SaO2) * VIS \> 15.0 with oxygen extraction \<25% (SaO2 - ScvO2/ SaO2)
Time frame: Up to 3 days
Inotrope Dependence
Vasoactive-inotrope score at 48 hours equal to or greater than that at ICU admission.
Time frame: Up to 2 days
Inotrope Free Days
Time frame: Up to 28 days
C-Reactive Protein Concentrations
Time frame: Measured at 1 day
Composite Outcome of mechanical circulatory support, acute renal failure, prolonged intubation and operative mortality.
Time frame: Up to 30 days
Cytokine Concentration (Patient Plasma)
C3, C3a, C3b, C5, C5a, IL-1, IL1-Ra, IL-6, IL-10, TNF, CXCL-8 among others. The final selection of mediators will be subject to final pilot study results and assay availability. Taken at baseline, 0 hours and 24 hours after CPB.
Time frame: Up to 1 day
Loop Diuretic Use
Total loop diuretic (mg/kg), measured in furosemide equivalents, during the first 7 post-operative days.
Time frame: Up to 7 days
Peak Vasoactive-Inotrope Score
Time frame: Up to 5 days
Peak Ventilation Index
Time frame: Up to 5 days
Peak Oxygenation Index
Time frame: Up to 5 days
Prolonged Intubation
Mechanical ventilation for more than 7 days
Time frame: Up to 28 days
Inotrope Time
Time frame: Up to 28 days
Acute Kidney Injury
KDIGO Criteria
Time frame: Up to 28 days
ICU Length of Stay
Time frame: Up to 30 days
Hospital Length of Stay
Time frame: Up to 60 days
Haptoglobin (Plasma)
Time frame: Up to 1 day
Complete blood count
Time frame: Up to 5 days
Lactate
Measured by arterial blood gas (mM)
Time frame: Up to 5 days
Creatinine
Blood Concentration (uM)
Time frame: Up to 5 days
Vasoactive-Ventilation Renal Score
Taken in time series at ICU admission, 12, 24, 36, 48, 72, 96 and 120 hours.
Time frame: Up to 5 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.