Cardiovascular Disease Clinical Trial
Official title:
Study to Evaluate the Use of RenalGuard to Protect Patients at High Risk of AKI (STRENGTH)
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.
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.
;
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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