Ultrafiltration for Heart Surgery in Children
(ULTRA Trial)
Recruiting in Palo Alto (17 mi)
Age: Any Age
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: IWK Health Centre
Disqualifiers: Severe hematologic, genetic syndromes, others
No Placebo Group
Approved in 3 Jurisdictions
Trial Summary
What is the purpose of this trial?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.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the treatment Ultrafiltration for Heart Surgery in Children?
Research shows that using modified ultrafiltration (a process to remove excess fluid) during heart surgery in children can help reduce complications and improve recovery. It helps manage fluid levels and reduces harmful effects from the surgery, leading to better outcomes for young patients.
12345How is the ultrafiltration treatment for heart surgery in children different from other treatments?
Ultrafiltration, including its modified forms like SBUF-SMUF, is unique because it helps reduce fluid overload and inflammation during pediatric heart surgery by filtering excess fluid and inflammatory substances from the blood, which can improve recovery and reduce complications compared to standard treatments.
12456Eligibility Criteria
This trial is for children with congenital heart disease weighing between 2.5 to 15kg, who are scheduled for cardiac surgery requiring cardiopulmonary bypass. Parents or guardians must consent to participate. It excludes those over 15kg (with some exceptions), without planned CPB use, isolated ASD repair, severe blood disorders, certain genetic syndromes with immune dysfunction, immunodeficiency syndromes, and severe liver or kidney disease.Inclusion Criteria
My child, weighing between 2.5 and 15kg, is scheduled for heart surgery with cardiopulmonary bypass.
Parent or legal substitute decision-maker informed written consent to participate in the study.
Exclusion Criteria
I do not have severe liver or kidney disease.
I have a severe blood disorder like sickle cell or hemophilia.
I have a genetic condition like DiGeorge, Trisomy 18 or 13, or Noonan syndrome.
+5 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Surgery and Intra-operative Ultrafiltration
Participants undergo cardiac surgery with either high-exchange or low-exchange ultrafiltration to manage inflammation and fluid overload
1 day
Post-operative Monitoring
Participants are monitored for post-operative outcomes including cytokine levels, kidney function, and ventilation needs
7 days
Daily monitoring in ICU
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessment of prolonged intubation and acute kidney injury
28 days
Participant Groups
The study tests two ultrafiltration protocols during heart surgery in kids: high-exchange (60ml/kg/hr) versus low-exchange (6ml/kg/hr). The goal is to see which better reduces inflammation from the heart-lung machine used in surgery and improves recovery outcomes.
2Treatment groups
Experimental Treatment
Active Control
Group I: High-Exchange UltrafiltrationExperimental Treatment1 Intervention
Subzero-Balance Simple Modified Ultrafiltration (60ml/kg/hour)
Group II: Low-Exchange UltrafiltrationActive Control1 Intervention
Subzero-Balance Simple Modified Ultrafiltration (6ml/kg/hour)
Ultrafiltration is already approved in United States, Canada, European Union for the following indications:
🇺🇸 Approved in United States as Ultrafiltration for:
- Fluid overload management in pediatric cardiac surgery
- Reduction of inflammatory response in cardiac operations
🇨🇦 Approved in Canada as Ultrafiltration for:
- Fluid overload management in pediatric cardiac surgery
- Reduction of inflammatory response in cardiac operations
🇪🇺 Approved in European Union as Ultrafiltration for:
- Fluid overload management in pediatric cardiac surgery
- Reduction of inflammatory response in cardiac operations
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
IWK Health CentreHalifax, Canada
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Who Is Running the Clinical Trial?
IWK Health CentreLead Sponsor
References
Effects of modified ultrafiltration and conventional ultrafiltration combination on perioperative clinical outcomes in pediatric cardiac surgery: A meta-analysis. [2021]This meta-analysis was performed to review the effects of the addition of modified ultrafiltration (MUF) and conventional ultrafiltration (CUF) to CUF alone on postoperative hemoglobin, surgical and ultrafiltration data, and postoperative clinical outcomes in pediatric patients undergoing cardiac surgery.
Subzero balance - simple modified ultrafiltration (SBUF-SMUF) technique for pediatric cardiopulmonary bypass. [2022]The use of cardiopulmonary bypass (CPB) can be associated with significant hemodilution, coagulopathy and a systemic inflammatory response for infants and children undergoing cardiac surgery. Intra-operative ultrafiltration has been used for decades to ameliorate these harmful effects. The novel combination of a continuous and non-continuous form of ultrafiltration, Subzero Balance Simple Modified Ultrafiltration (SBUF-SMUF) here described, seeks to enhance recovery from pediatric cardiac surgery and CPB.
Modified ultrafiltration reduces postoperative morbidity after cavopulmonary connection. [2019]Modified ultrafiltration reduces the deleterious effects of cardiopulmonary bypass in children. Patients undergoing repair of single-ventricle cardiac anomalies may be particularly sensitive to these adverse effects, and benefit from the use of modified ultrafiltration.
The effect of combined conventional and modified ultrafiltration on mechanical ventilation and hemodynamic changes in congenital heart surgery. [2020]Cardiopulmonary bypass is associated with increased fluid accumulation around the heart which influences pulmonary and cardiac diastolic function. The aim of this study was to compare the effects of modified ultrafiltration (MUF) versus conventional ultrafiltration (CUF) on duration of mechanical ventilation and hemodynamic status in children undergoing congenital heart surgery.
The effect of modified ultrafiltration duration on pulmonary functions and hemodynamics in newborns and infants following arterial switch operation*. [2014]Modified ultrafiltration is used to ameliorate the deleterious effects of cardiopulmonary bypass in pediatric cardiac surgery patients. The ideal duration of modified ultrafiltration has not been established yet. We investigated the effects of extended duration of modified ultrafiltration on pulmonary functions and hemodynamics in the early postoperative period in newborns and infants who had transposition of great arteries operations.
Efficacy of ultrafiltration in removing inflammatory mediators during pediatric cardiac operations. [2010]Conventional and modified ultrafiltration was used in pediatric cardiac operations to reduce volume overload and total body water. The purpose of this study was to compare the efficacy of these techniques in removing inflammatory mediators during cardiopulmonary bypass.