NCT02793661

Study to Evaluate the Use of RenalGuard to Protect Patients at High Risk of AKI

Study to Evaluate the Use of RenalGuard to Protect Patients at High Risk of AKI (STRENGTH)

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: European Cardiovascular Research Center · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cardiovascular Disease
• Acute Kidney Injury

Interventions

Type	Name	Description
DEVICE	RenalGuard	Replacement of urine output by infusion of a matched volume of sterile replacement solution to maintain a patient's intravascular fluid volume. Diuretic is administered to reach an optimum urine flow and protect efficiently the patients' kidneys.
OTHER	Control	Hydration protocol following ESC Guidelines 2014

Timeline

• Start date: 2016-05-01
• Primary completion: 2017-05-01
• Completion: 2018-05-01
• First posted: 2016-06-08
• Last updated: 2016-09-05

Locations

7 sites across 2 countries: France, Germany