Ignite Creation Date:
2024-05-06 @ 4:14 PM
Last Modification Date:
2024-10-26 @ 2:06 PM
Study NCT ID:
NCT04920643
Status:
RECRUITING
Last Update Posted:
2024-05-31
First Post:
2021-05-30
Brief Title:
High-exchange ULTrafiltration to Enhance Recovery After Pediatric Cardiac Surgery
Sponsor:
IWK Health Centre
Organization:
IWK Health Centre
Study Overview
Official Title:
High-exchange ULTrafiltration to Enhance Recovery After Pediatric Cardiac Surgery ULTRA A Canadian Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ULTRA
Brief Summary:
Malformations of the heart are common 135 million infants are born each year with congenital heart disease Many of these defects carry a considerable threat to the individuals quality of life as well as survival Along with focused medical management surgical repair remains a standard of care for more than 25000 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 individuals 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 childrens 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 60mlkghr and a low-exchange SBUF-SMUF 6mlkghr 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
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 childrens 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 60mlkghr and a low-exchange SBUF-SMUF 6mlkghr 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None