Preventing contrAst induced Nephropathy after TranscathEter aortic valve Replacement

Phase 4

Completed

Conditions: aortic stenosis
kidney injury
10046973
10029149

Registration Number: NL-OMON43053

Lead Sponsor: Sint Antonius Ziekenhuis

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 200

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>1. Primary efficacy outcome is the development of contrast-induced nefropathy<br /><br>(CIN).<br /><br>2. Primary safety outcome is the development of acute heart failure due to<br /><br>volume expansion.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>1. Occurrence of the composite of CIN or acute heart failure due to volume<br /><br>expansion.<br /><br>2. Maximal relative change in serum creatinine measured between 0 and 72 h<br /><br>post-TAVI compared with baseline.<br /><br>3. Incidence of acute kidney injury, according to AKIN classification.<br /><br>4. The need for dialysis.<br /><br>5. The need for and number of blood transfusions.<br /><br>6. Length of hospital stay.<br /><br>7. Recovery of renal function in CIN patients [recovery defined as an increase<br /><br>in serum creatinine <25% or <44 µmol/L (0.5 mg/dL) measured at 1 month<br /><br>post-TAVI compared with baseline]</p><br>