Preventing contrAst Induced Nephropathy After TranscathEter Aortic Valve Replacement

Study Overview
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Brief Summary
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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.

Official Title
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Preventing Contrast Induced Nephropathy After Transcatheter Aortic Valve Replacement

Conditions
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Aortic Valve Disease, Chronic Kidney Disease, Contrast Induced Nephropathy, Acute Kidney Injury

Intervention / Treatment
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* Drug: sodium bicarbonate
* Drug: hypotone saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient has provided written informed consent. Patient is undergoing TAVI. Patient has an estimated GFR <60ml/min/1.73m2. Exclusion Criteria: Patient has end-stage kidney disease requiring dialysis. Emergent TAVI (planned before next working day). Recent exposure to radiographic contrast agents (within 2 days prior to the TAVI). Allergy to contrast agent. Planned administration of dopamine, mannitol, fenoldopam or N-acetylcysteine during the intended time of the study. Need for continuous hydration therapy (e.g. sepsis). Multiple myeloma. Contra-indication to sodium bicarbonate.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: sodium bicarbonate<br>250ml 1.4% sodium bicarbonate 1 h before TAVR | Drug: sodium bicarbonate<br> <br> |
| Active Comparator: hypotone saline<br>0.65% sodiumchloride 1 ml/kg/h for 12 h before and 12 h after TAVR | Drug: hypotone saline<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite of CIN or acute heart failure |  | Day 3 | 
| Maximal relative change in serum creatinine |  | Day 3 | 
| Acute kidney injury | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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transcatheter aortic valve implantation, transcatheter aortic valve replacement