At a glance
ClinicalIndex Comparison Record- ✓Age 18 years or older
- ✓Elective cardiac or aortic surgery requiring cardiopulmonary bypass longer than 90 minutes
- ✓Stable baseline kidney function without creatinine increase ≥0.3 mg/dL in prior 3 months and no prior renal replacement therapy
- ✓Clinical evidence of endothelial dysfunction on standardized questionnaire
- ✕eGFR less than 30 mL/min/1.73 m²
- ✕Emergency or urgent cardiac surgery
- ✕Life expectancy less than 1 year
- ✕Systolic blood pressure less than 90 mmHg
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Prevention of Acute Kidney Injury by Nitric Oxide in Prolonged Cardiopulmonary Bypass. A Double Blind Controlled Randomized Trial in Cardiac Surgical Patients With Endothelial Dysfunction.
In Brief
A Phase 3 clinical trial evaluating Nitric Oxide and Placebo for Acute Kidney Injury. Completed, enrolled 250 participants across 1 site.
Detailed Summary
The purpose of this study is to determine whether nitric oxide is effective in the treatment of acute kidney injury in cardiac surgical patients with sign and laboratory data suggesting endothelial dysfunction undergoing prolonged cardiopulmonary bypass.
Study Details
Timeline
Interventions
Inhaled nitric oxide will be administered in a final concentration of 80 ppm. The treatment will begin at the onset of the cardiopulmonary bypass until to 24h after Intensive Care Unit (ICU) admission, including 2-4 hours of weaning from nitric oxide and careful hemodynamics monitoring.
This is the placebo group. Nitrogen will be added instead of nitric oxide.