Nitrite Infusion in High Risk Patients Undergoing Cardiopulmonary Bypass
Withdrawn before enrolling · Phase 3 · Has a placebo group
Conditions studied: Acute Kidney Injury
In brief
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.
Key facts
- Study ID
- NCT03331146
- Run by
- University of Alabama at Birmingham
- People needed
- 0
- Starts
- 2018-10-01
- Expected to finish
- 2020-12-01
- Last updated by the study team
- 2018-09-27
Who can join
Age: 19 and older, up to 100. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- UAB Department of Anesthesiology and Perioperative Medicine — Birmingham, Alabama, United States
Full record on ClinicalTrials.gov
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