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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
200
St Antonius hospital
Nieuwegein, Utrecht, Netherlands
RECRUITINGContrast induced nephropathy
CIN is defined as an increase in Scr \>0.5 mg/dL or 25% within 72 hours
Time frame: Day 3
Acute heart failure due to volume expansion
Time frame: Day 3
Composite of CIN or acute heart failure
Time frame: Day 3
Maximal relative change in serum creatinine
Time frame: Day 3
Acute kidney injury
According to AKIN classification
Time frame: Day 3
Need for dialysis
Time frame: Day 30
Need for blood transfusions
Time frame: Day 3 and Day 30
Number of blood transfusions
Time frame: Day 3 and Day 30
Length of hospital stay
Time frame: 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
Time frame: Day 30
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.