drugset / Trial / NCT03331146
Nitrite Infusion in High Risk Patients Undergoing Cardiopulmonary Bypass
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Sodium Nitrite | Small molecule | 267 ug/kg | Intravenous |