Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06595680
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-06
Brief Title:
Development of an Innovative Hemodialysis Method to Improve Dialytic Clearance of Protein-bound Uremic Toxins
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Development of an Innovative Hemodialysis Method to Improve Dialytic Clearance of Protein-bound Uremic Toxins
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CLEARTOX
Brief Summary:
Current hemodialysis techniques fail to efficiently remove protein-bound uremic toxins such as p-cresyl sulfate p-CS or indoxyl sulfate IS due to their strong binding to serum albumin The accumulation of these toxins in end-stage renal failure patients on hemodialysis is strongly suspected to contribute to the significant morbidity and mortality observed in this population
Pre-clinical studies conducted previously showed that medium-chain fatty acids such as sodium octanoate and decanoate which are natural ligands of albumin can effectively displace the binding of uremic toxins on serum albumin and thus promote their elimination during a hemodialysis session
Medialipide 20 Braun is an emulsion of medium chain triglycerides MCT 6 to 12 carbons used in parenteral nutrition Medialipide constitutes a relevant clinical formulation for the administration of octanoate and decanoate because it contains 94 of sodium octanoate and decanoate
In this study a proof of concept intervention will be carried out to study the effect on the clearance uremic toxins clearance of the perfusion of Medialipide emulsion as a sodium octanoate and decanoate donor in patients during their hemodialysis session compared to a control situation Sodium chloride NaCl 09
Pre-clinical studies conducted previously showed that medium-chain fatty acids such as sodium octanoate and decanoate which are natural ligands of albumin can effectively displace the binding of uremic toxins on serum albumin and thus promote their elimination during a hemodialysis session
Medialipide 20 Braun is an emulsion of medium chain triglycerides MCT 6 to 12 carbons used in parenteral nutrition Medialipide constitutes a relevant clinical formulation for the administration of octanoate and decanoate because it contains 94 of sodium octanoate and decanoate
In this study a proof of concept intervention will be carried out to study the effect on the clearance uremic toxins clearance of the perfusion of Medialipide emulsion as a sodium octanoate and decanoate donor in patients during their hemodialysis session compared to a control situation Sodium chloride NaCl 09
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None