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

European Cardiovascular Research Institute (ECRI)

Status: Unknown

Conditions: Acute Kidney Injury; Cardiovascular Disease

Treatments: Device: RenalGuard; Other: Control

Study type: Interventional

Funder types: NETWORK; Industry

Identifiers

NCT02793661

REN-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age > 18 years old
• 15 ml/min/m2 ≤ eGFR ≤ 40 ml/min/m2
• High volume contrast-requiring cardiovascular procedures (estimated contrast volume > 3 times eGFR value)
• Patient has agreed to all FU testing

Exclusion criteria

• Administration of iodine contrast media within 5 days before index procedure
• Emergency procedure or primary PCI
• Patients with pulmonary edema or cardiogenic shock (Killip 3 or 4)
• Hypoxemia defined as SaO2 ≤ 90% and/or PaO2 ≤ 80 mmHg on room air
• Acute Kidney Injury requiring dialysis before the procedure
• Multiple myeloma or cancer treated with chemotherapy
• Subjet is anuric
• Subject has been hospitalized for any change in renal function or has undergone renal replacement therapy (hemodialysis or hemofiltration) within the past month
• Known hypersensitivity to furosemide active ingredient or excipient
• Renal insufficiency with oligoanuria resistant to furosemide or caused by nephrotoxic or hepatotoxic substances
• Pre-coma or coma induced by an hepatic encephalopathy
• Severe hypokalemia, sever hyponatremia, hypovolemia with or without hypotension or dehydration
• Hypersensitivity to sulfamides
• Enrollment in another study unless the study is a registry or unless primary endpoint is reached
• Expected life expectancy < 1 year
• Pregnant or breastfeeding patient
• Patient under trusteeship or guardianship
• Patient is unable / unwilling to provide an informed consent

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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300 participants in 2 patient groups

RenalGuard Arm

Experimental group

Description:

In order to prevent patients from acute kidney injury, patients will receive the RenalGuard Therapy delivered by the RenalGuard system from one hour before the cardiovascular intervention to 4 hours after the intervention.

Treatment:

Device: RenalGuard

Control Arm

Active Comparator group

Description:

Patient will received standard treatment, as per ESC Guidelines 2014, to prevent from acute kidney injury.

Treatment:

Other: Control