Ignite Creation Date:
2024-05-06 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 1:54 PM
Study NCT ID:
NCT04714710
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-09-15
First Post:
2021-01-05
Brief Title:
Potassium Canrenoate in Brain-dead Organ Donors Randomized Controlled Clinical Trial
Sponsor:
Central Hospital Nancy France
Organization:
Central Hospital Nancy France
Study Overview
Official Title:
Evaluation of the Hemodynamic Stability of Potassium Canrenoate in Brain-dead Organ Donors Randomized Controlled Clinical Trial
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-08
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:
CANREO-PMO
Brief Summary:
Given the current organ shortage improving the qualityefficacy of harvested grafts from expanded criteria donors is essential to substantially increase the number of potential donors Preclinical studies have shown that blocking the vascular mineralocorticoid receptor MR mitigates ischemia-reperfusion injury IR and prevents renal dysfunction following acute kidney injury Potassium canrenoate is an intravenous MR antagonist Blocking the MR upstream from aortic cross clamping is likely the most effective strategy to limit IR injury
Yet brain-dead donors are prone to severe hemodynamic instability and polyuria Consequently this study seeks to assess the hemodynamic tolerance of the use of potassium canrenoate in this context as a first step to a large-scale clinical trial testing the impact of this therapeutic intervention on the survival of kidney grafts
Yet brain-dead donors are prone to severe hemodynamic instability and polyuria Consequently this study seeks to assess the hemodynamic tolerance of the use of potassium canrenoate in this context as a first step to a large-scale clinical trial testing the impact of this therapeutic intervention on the survival of kidney grafts
Detailed Description:
In this single-center double-blind placebo-controlled clinical trial we seek to evaluate the effect of the administration of 200 mg of IV potassium canrenoate vs placebo in brain-dead donors aged 18 years or more - within 10 hours after the diagnosis of brain death is made and before the departure to operating room
The primary objective is to assess the impact of potassium canrenoate administration vs placebo on the hemodynamics of brain-dead subjects who are candidates for kidney or multiple organ harvesting including renal
The vital status and renal function of kidney recipients will be followed at 3 months 1 year 3 years and 10 years from transplant main secondary objectives
The primary objective is to assess the impact of potassium canrenoate administration vs placebo on the hemodynamics of brain-dead subjects who are candidates for kidney or multiple organ harvesting including renal
The vital status and renal function of kidney recipients will be followed at 3 months 1 year 3 years and 10 years from transplant main secondary objectives
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