Status:
WITHDRAWN
Nitrite Infusion in High Risk Patients Undergoing Cardiopulmonary Bypass
Lead Sponsor:
University of Alabama at Birmingham
Conditions:
Acute Kidney Injury
Eligibility:
All Genders
19-100 years
Phase:
PHASE3
Brief 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...
Detailed Description
Acute kidney injury is one of the most untoward consequences of cardiac-surgery with the use of CPB. As such it is associated with a high mortality and morbidity and health care expense. Unfortunately...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2020
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03331146
Start Date
October 1 2018
End Date
December 1 2020
Last Update
September 27 2018
Active Locations (1)
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1
UAB Department of Anesthesiology and Perioperative Medicine
Birmingham, Alabama, United States, 35249