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Chronic kidney disease (CKD) and (subsequent) acute kidney injury are frequent in patients undergoing transcatheter aortic valve implantation (TAVI). Moreover, these patients are easily hypervolemic and susceptible for cardiac decompensation. Prevention of contrast induced nephropathy (CIN) has not yet been studied in these patients, and evidence on different strategies is urgently needed. The objective of this study is to evaluate the efficacy of 250ml 1.4% sodium bicarbonate versus hypotone saline (0.65% sodiumchloride) hydration prior to TAVI in patients with CKD to prevent CIN.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| sodium bicarbonate | Active Comparator | 250ml 1.4% sodium bicarbonate 1 h before TAVR |
|
| hypotone saline | Active Comparator | 0.65% sodiumchloride 1 ml/kg/h for 12 h before and 12 h after TAVR |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| sodium bicarbonate | Drug |
| ||
| hypotone saline |
| Measure | Description | Time Frame |
|---|---|---|
| Contrast induced nephropathy | CIN is defined as an increase in Scr >0.5 mg/dL or 25% within 72 hours | Day 3 |
| Acute heart failure due to volume expansion | Day 3 |
| Measure | Description | Time Frame |
|---|---|---|
| Composite of CIN or acute heart failure | Day 3 | |
| Maximal relative change in serum creatinine | Day 3 | |
| Acute kidney injury |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Vincent Nijenhuis, MD | Contact | +31 65 274 2486 | v.nijenhuis@antoniusziekenhuis.nl |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St Antonius hospital | Recruiting | Nieuwegein | Utrecht | 3435CM | Netherlands |
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| ID | Term |
|---|---|
| D000082862 | Aortic Valve Disease |
| D051436 | Renal Insufficiency, Chronic |
| D058186 | Acute Kidney Injury |
| ID | Term |
|---|---|
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D051437 | Renal Insufficiency |
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| ID | Term |
|---|---|
| D017693 | Sodium Bicarbonate |
| ID | Term |
|---|---|
| D001639 | Bicarbonates |
| D002254 | Carbonates |
| D002255 | Carbonic Acid |
| D017554 | Carbon Compounds, Inorganic |
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|
According to AKIN classification |
| Day 3 |
| Need for dialysis | Day 30 |
| Need for blood transfusions | Day 3 and Day 30 |
| Number of blood transfusions | Day 3 and Day 30 |
| Length of hospital stay | Day 30 |
| Recovery of renal function in CIN patients | Recovery defined as an increase in serum creatinine <25% or <44 μmol/L (0.5 mg/dL) measured at 1 month post-TAVI compared with baseline | Day 30 |
| D007674 |
| Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| 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 |
| D007287 |
| Inorganic Chemicals |
| D017670 | Sodium Compounds |