Ignite Creation Date:
2025-12-24 @ 12:42 PM
Ignite Modification Date:
2026-04-20 @ 12:08 PM
Study NCT ID:
NCT02793661
Status:
UNKNOWN
Last Update Posted:
2016-09-05
First Post:
2016-06-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Evaluate the Use of RenalGuard to Protect Patients at High Risk of AKI
Sponsor:
European Cardiovascular Research Center
Organization:
Study Overview
Official Title:
Study to Evaluate the Use of RenalGuard to Protect Patients at High Risk of AKI (STRENGTH)
Status:
UNKNOWN
Status Verified Date:
2016-09
Last Known Status:
RECRUITING
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:
STRENGTH
Brief Summary:
The Strength study aim to evaluate the use of the RenalGuard device to protect the patients at high risk to develop acute kidney injury following a complex cardiovascular intervention requiring a high volume of contrast.
Detailed Description:
The Strength Trial is a randomized, international (France and Germany) and multicentre (7) trial.
The patients population targeted is suffering from kidney insufficiency (estimated Glomerular Filtration Rate (eGFR) between 15 to 40 ml/min/m2) need to go through a complex cardiovascular intervention..
This is a population of patients at high risk to develop AKI following contrast media administration and complex cardiovascular interventions require a high amount of contrast.
Standard treatment is hydration but with risk of hyper and hypohydration for this population of patients. RenalGuard insure the replacement of the urine output by infusion of a matched volume of sterile replacement solution to maintain patients' intravascular fluid volume.
The patients are randomized to be protected from contrast-induced nephropathy with the use of RenalGuard or by standard hydration treatment and will be followed-up during 12 months.
The patients population targeted is suffering from kidney insufficiency (estimated Glomerular Filtration Rate (eGFR) between 15 to 40 ml/min/m2) need to go through a complex cardiovascular intervention..
This is a population of patients at high risk to develop AKI following contrast media administration and complex cardiovascular interventions require a high amount of contrast.
Standard treatment is hydration but with risk of hyper and hypohydration for this population of patients. RenalGuard insure the replacement of the urine output by infusion of a matched volume of sterile replacement solution to maintain patients' intravascular fluid volume.
The patients are randomized to be protected from contrast-induced nephropathy with the use of RenalGuard or by standard hydration treatment and will be followed-up during 12 months.
Study Oversight
Has Oversight DMC:
False
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?: