drugset / Trial / NCT03121053

Preventing contrAst Induced Nephropathy After TranscathEter Aortic Valve Replacement

NCT03121053

Phase 4 Unknown 200 enrolled St. Antonius Hospital
RandomizedParallel-groupOpen-labelPrevention

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.

Timeline

Start
2016-10
Primary completion
2018-12
Completion
2019-01

Drugs

EvaluationDrugModalityDoseRoute
Comparator hypotone saline Unknown 1 ml
Comparator sodium bicarbonate Diagnostic / imaging agent 250 ml