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| Name | Class |
|---|---|
| RenalGuard Solutions, Inc. | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RenalGuard Arm | Experimental | 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 | Active Comparator | Patient will received standard treatment, as per ESC Guidelines 2014, to prevent from acute kidney injury. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RenalGuard | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Occurence of contrast-induced nephropathy | The occurence of contrast-induced nephropathy will be determined:
| Within 5 days |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jessica Heringer, PhD | Contact | +33 (0)1 76 73 92 16 | jheringer@cerc-europe.org | |
| Laure Morsiani, Ph D | Contact | +33 (0)1 76 73 92 36 | lmorsiani@cerc-europe.org |
| Name | Affiliation | Role |
|---|---|---|
| Andrew Halpert | RenalGuard Solutions, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Privé Jacques Cartier | Recruiting | Massy | 91300 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39878152 | Derived | Hashimoto H, Yamada H, Murata M, Watanabe N. Diuretics for preventing and treating acute kidney injury. Cochrane Database Syst Rev. 2025 Jan 29;1(1):CD014937. doi: 10.1002/14651858.CD014937.pub2. |
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| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
| D058186 | Acute Kidney Injury |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| Control | Other | Hydration protocol following ESC Guidelines 2014 |
|
| 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 |
| Hôpital Privé Claude Galien | Recruiting | Quincy-sous-Sénart | 91480 | France |
|
| CHU Rangueil | Recruiting | Toulouse | 31059 | France |
|
| Clinique Pasteur | Recruiting | Toulouse | 31076 | France |
|
| Universitätsklinikum Bonn | Not yet recruiting | Bonn | 53105 | Germany |
|
| Cardiovasculares Centrum Frankfurt | Recruiting | Frankfurt | 60389 | Germany |
|
| St Josefs Hospital | Not yet recruiting | Wiesbaden | 65189 | Germany |
|
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |