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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Cardiovascular Disease, Acute Kidney Injury

Intervention / Treatment
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* Device: RenalGuard
* Other: Control


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RenalGuard Arm<br>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. | Device: RenalGuard<br>* 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.<br>|
| Active Comparator: Control Arm<br>Patient will received standard treatment, as per ESC Guidelines 2014, to prevent from acute kidney injury. | Other: Control<br>* Hydration protocol following ESC Guidelines 2014<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurence of contrast-induced nephropathy | The occurence of contrast-induced nephropathy will be determined: by an elevation, within 3 days from requiring contrast-procedure, of the serum creatinine (rise of 0.3mg/dl or of 25% compared to basal value) and/or by the need for dialysis within 5 fays from requiring contrast-procedure | Within 5 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in serum creatinin value |  | at 12 +-1 months | 
| Change in the estimated glomerular filtration rate |  | at 12 +-1 months | 
| Percentage of patients on chronic dialysis |  | at 12 +-1 months | 
| Percentage of patients on temporary dialysis |  | at 12 +-1 months | 
| In hospital significant urinary bleeding, infection or any other major complication cause by the urinary catheter |  | within 5 days from procedure | 
| Composite of major adverse cardiovascular and cerebrovascular events (death, myocardial infarction, stroke, revascularization) |  | at 12 +-1 months | 
| Individual MACCEs components (death, myocardial infarction, stroke, revascularization) |  | at 12 +-1 months | 
| Economic evaluation of RenalGuard compared to standard renal protection according to ESC guidelines | cost utility analysis | Index hospitalization (including staged procedures) and 12+- 1 months |