Acute Kidney Injury, Cardiovascular Disease
Conditions
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.
Interventions
DEVICERenalGuard
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.
OTHERControl
Hydration protocol following ESC Guidelines 2014
Sponsors
RenalGuard Solutions, Inc.
European Cardiovascular Research Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Individual MACCEs components (death, myocardial infarction, stroke, revascularization) | at 12 +-1 months | — |
| Change in serum creatinin value | at 12 +-1 months | — |
| Change in the estimated glomerular filtration rate | 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 | — |
| 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 | — |
Countries
France, Germany
Contacts
Primary ContactJessica Heringer, PhD
Backup ContactLaure Morsiani, Ph D
Outcome results
None listed