drugset / Trial / NCT03331146

Nitrite Infusion in High Risk Patients Undergoing Cardiopulmonary Bypass

NCT03331146

RandomizedParallel-groupTriple-blindPrevention

Summary

The main objective of this study is to evaluate the efficacy of intravenous sodium nitrite compared with placebo in reducing the occurrence of CSA-AK as diagnosed by KDIGO criteria during the first 72 hrs after cardiac surgery in high-risk patients undergoing cardiac surgery. Secondary objectives are to determine whether IV sodium nitrite achieves adequate pharmacokinetics (PK) in patients undergoing cardiac surgery with the use of CPB.

Timeline

Start
2018-10-01
Primary completion
2019-06-01
Completion
2020-12-01

Drugs

EvaluationDrugModalityDoseRoute
Comparator Sodium Nitrite Small molecule 267 ug/kg Intravenous

Indications