Nitrite Infusion in High Risk Patients Undergoing Cardiopulmonary Bypass

• Status: Withdrawn
• Trial end date: 2020-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Alabama at Birmingham
• Treatments: Anesthetics

Criteria

Inclusion Criteria:

• Patients CCFS score ≥ 6 (Table 1)

• Patients admitted to UAB cardiac intensive care unit (CICU) following elective cardiac surgery with cardiopulmonary bypass under general endotracheal anesthesia

• 19 years old

• Estimated glomerular filtration rate (eGFR) ≥ 30 ml/min/1.73 m2

Exclusion Criteria:

• Prisoners directly admitted from a correctional facility.

• Children < 19 years or under 50 kg body weight if age is unknown.

• Patients enrolled in a concurrent ongoing interventional, randomized clinical trial.

• Patients with end stage renal disease or preexisting GFR <30 mL/min/1.73 m2 or need for dialysis. 34

• Patients with end stage heart disease on the cardiac transplant list.

• Patients undergoing procedures without the use of CPB

• All transplant patients.

• Patients on ventricular assist devices.

• Patients undergoing emergency procedures.

• Patients with glucose 6-dehydrogenase deficiency

• Pregnancy