Preventing Contrast Induced Nephropathy After Transcatheter Aortic Valve Replacement
Overview
- Phase
- Phase 4
- Intervention
- hypotone saline
- Conditions
- Aortic Valve Disease
- Sponsor
- St. Antonius Hospital
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- Contrast induced nephropathy
- Last Updated
- 9 years ago
Overview
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.
Investigators
Jan van der Heyden
Principal Investigator
St. Antonius Hospital
Eligibility Criteria
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.
Arms & Interventions
hypotone saline
0.65% sodiumchloride 1 ml/kg/h for 12 h before and 12 h after TAVR
Intervention: hypotone saline
sodium bicarbonate
250ml 1.4% sodium bicarbonate 1 h before TAVR
Intervention: sodium bicarbonate
Outcomes
Primary Outcomes
Contrast induced nephropathy
Time Frame: 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
Time Frame: Day 3
Secondary Outcomes
- Composite of CIN or acute heart failure(Day 3)
- Maximal relative change in serum creatinine(Day 3)
- Acute kidney injury(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(Day 30)