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Randomized controlled, single-center trial randomizing patients with chronic kidney disease and symptomatic severe aortic valve stenosis undergoing transcatheter aortic valve implantation (TAVI). Patients are randomized in a 1:1 ratio to periprocedural intravenous hydration matched to urine output using the RenalGuard system and to standard hydration. The purpose of the study is to test, wether the controlled intravenous hydration with the RenalGuard system is superior to standard hydration to prevent acute kidney injury after TAVI.
Acute kidney injury (AKI) after transcatheter aortic valve implantation (TAVI) is associated with worse outcome. The RenalGuard system was developed to prevent AKI by a controlled furosemide-induced diuresis with matched isotonic intravenous hydration. It is based on the theory, that a high urinary output prevents contrast media-induced nephropathy (CIN).
The present study is a prospective, randomized trial to investigate wether a matched intravenous hydration using the RenalGuard system is superior to standard pre- and postprocedural intravenous hydration in patients with severe aortic valve stenosis and chronic kidney disease undergoing TAVI. Primary endpoint is the occurrence of AKI after TAVI.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RenalGuard group | Active Comparator |
| |
| Control group | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RenalGuard system | Device | Periprocedural intravenous hydration matched to urinary output. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Acute kidney injury | Increase of serum-creatinine of 0,3 mg/dl in pre-procedural serum-creatinine within 7 days after Transcatheter aortic valve implantation | Within 7 days after Transcatheter aortic valve implantation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ulrich Schäfer, MD | Universitätsklinikum Hamburg-Eppendorf | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Medical Center Hamburg-Eppendorf | Hamburg | 20246 | Germany |
| 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. | |
| 37264143 | Derived | Voigtlander-Buschmann L, Schafer S, Schmidt-Lauber C, Weimann J, Shenas M, Giraldo Cortes J, Kuta PM, Zeller T, Twerenbold R, Seiffert M, Schofer N, Schneeberger Y, Schafer A, Schirmer J, Reichenspurner H, Blankenberg S, Conradi L, Schafer U. Effect of periprocedural furosemide-induced diuresis with matched isotonic intravenous hydration in patients with chronic kidney disease undergoing transcatheter aortic valve implantation. Clin Res Cardiol. 2024 Jun;113(6):801-811. doi: 10.1007/s00392-023-02234-z. Epub 2023 Jun 1. |
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| ID | Term |
|---|---|
| D058186 | Acute Kidney Injury |
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |