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

Not Applicable

• Conditions: Acute Kidney Injury; Cardiovascular Disease
• Interventions: Device: RenalGuard; Other: Control

• Registration Number: NCT02793661
• Lead Sponsor: European Cardiovascular Research Center

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.

Study Timeline

• Study Start: 2016-05
• Study First Submitted: 2016-06-03
• Study First Submitted QC: 2016-06-03
• Study First Posted: 2016-06-08
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-02
• Last Update Posted: 2016-09-05
• Primary Completion: 2017-05
• Study Completion: 2018-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
RenalGuard Arm	RenalGuard	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.
Control Arm	Control	Patient will received standard treatment, as per ESC Guidelines 2014, to prevent from acute kidney injury.

Primary Outcome Measures

Name	Time	Method
Occurence of contrast-induced nephropathy	Within 5 days	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

Secondary Outcome Measures

Name	Time	Method
Change in serum creatinin value	at 12 +-1 months
Change in the estimated glomerular filtration rate	at 12 +-1 months
Economic evaluation of RenalGuard compared to standard renal protection according to ESC guidelines	Index hospitalization (including staged procedures) and 12+- 1 months	cost utility analysis
Percentage of patients on chronic dialysis	at 12 +-1 months
Composite of major adverse cardiovascular and cerebrovascular events (death, myocardial infarction, stroke, revascularization)	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
Individual MACCEs components (death, myocardial infarction, stroke, revascularization)	at 12 +-1 months

Trial Locations

Locations (7)

Hôpital Privé Jacques Cartier; 🇫🇷 Massy, France

Universitätsklinikum Bonn; 🇩🇪 Bonn, Germany

Hôpital Privé Claude Galien; 🇫🇷 Quincy-sous-sénart, France

Clinique Pasteur; 🇫🇷 Toulouse, France

CHU Rangueil; 🇫🇷 Toulouse, France

Cardiovasculares Centrum Frankfurt; 🇩🇪 Frankfurt, Germany

St Josefs Hospital; 🇩🇪 Wiesbaden, Germany