Ignite Creation Date:
2024-05-06 @ 5:47 PM
Last Modification Date:
2024-10-26 @ 2:35 PM
Study NCT ID:
NCT05430620
Status:
RECRUITING
Last Update Posted:
2024-05-23
First Post:
2022-06-17
Brief Title:
Intermittent Versus Continuous Surface O2 During HMP of DCD Kidneys
Sponsor:
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Organization:
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Study Overview
Official Title:
A Prospective Feasibility Trail to Compare the Efficacy of Intermittent Surface Oxygenation With Continuous Surface Oxygenation During Hypothermic Machine Perfusion of Kidneys Donated After Circulatory Death
Status:
RECRUITING
Status Verified Date:
2024-05
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:
HMPO2
Brief Summary:
The aim of the study is to evaluate the feasibility of this bubble and surface oxygenation and to determine the optimal timing of surface oxygenation continuous versus intermittent as alternative for membrane-oxygenated kidneys originating from DCD donors during HMP on early graft function in clinical practice
Detailed Description:
Kidneys originating from deceased donors after circulatory death DCD category 3 and 5 controlled will be preserved from procurement until transplantation on hypothermic machine perfusion conditions and prospectively randomized into 2 study groups 1 intermittent surface oxygenation during HMP surface oxygenation interrupted during organ transport 2-4hI-HMPO2 group and 2 continuous surface oxygenation during HMP surface oxygenation during the whole machine preservation period included organ transportC-HMPO2 group
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?:
False
Is an FDA AA801 Violation?:
None