Acute Kidney Injury, Aortic Valve Disease, Chronic Kidney Disease, Contrast Induced Nephropathy
Conditions
Keywords
transcatheter aortic valve implantation, transcatheter aortic valve replacement
Brief summary
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.
Interventions
DRUGsodium bicarbonate
DRUGhypotone saline
Sponsors
St. Antonius Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
1. Patient has provided written informed consent. 2. Patient is undergoing TAVI. 3. Patient has an estimated GFR \<60ml/min/1.73m2.
Exclusion criteria
1. Patient has end-stage kidney disease requiring dialysis. 2. Emergent TAVI (planned before next working day). 3. Recent exposure to radiographic contrast agents (within 2 days prior to the TAVI). 4. Allergy to contrast agent. 5. Planned administration of dopamine, mannitol, fenoldopam or N-acetylcysteine during the intended time of the study. 6. Need for continuous hydration therapy (e.g. sepsis). 7. Multiple myeloma. 8. Contra-indication to sodium bicarbonate.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Contrast induced nephropathy | Day 3 | CIN is defined as an increase in Scr \>0.5 mg/dL or 25% within 72 hours |
| Acute heart failure due to volume expansion | Day 3 | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Composite of CIN or acute heart failure | Day 3 | — |
| Maximal relative change in serum creatinine | Day 3 | — |
| Acute kidney injury | Day 3 | According to AKIN classification |
| 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 | Day 30 | 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 |
Countries
Netherlands
Contacts
Primary ContactVincent Nijenhuis, MD
Outcome results
None listed