Study to Evaluate the Use of RenalGuard to Protect Patients at High Risk of AKI (STRENGTH)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Cardiovascular Disease
- Sponsor
- European Cardiovascular Research Center
- Enrollment
- 300
- Locations
- 7
- Primary Endpoint
- Occurence of contrast-induced nephropathy
- Last Updated
- 9 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Occurence of contrast-induced nephropathy
Time Frame: 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 Outcomes
- 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)
- 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)