aortic stenosis kidney injury
Conditions
Interventions
Random 1:1 allocation to sodium bicarbonate 250mL 1 h before TAVI versus
hypotone saline 1 ml/kg/h for 12 h before and 12 h after TAVI.
Sponsors
Sint Antonius Ziekenhuis
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Patient has provided written informed consent. 2. Patient is undergoing TAVI. 3. Patient has an estimated GFR
Exclusion criteria
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 |
|---|---|
| 1. Primary efficacy outcome is the development of contrast-induced nefropathy (CIN). 2. Primary safety outcome is the development of acute heart failure due to volume expansion. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Occurrence of the composite of CIN or acute heart failure due to volume expansion. 2. Maximal relative change in serum creatinine measured between 0 and 72 h post-TAVI compared with baseline. 3. Incidence of acute kidney injury, according to AKIN classification. 4. The need for dialysis. 5. The need for and number of blood transfusions. 6. Length of hospital stay. 7. Recovery of renal function in CIN patients [recovery defined as an increase in serum creatinine | — |
Countries
Netherlands
Outcome results
None listed