Using nitric oxide to prevent kidney injury in patients with aortic dissection

Efficacy of Nitric Oxide Administration for Reducing the Risk of Acute Kidney Injury in Patients with Acute Type a Aortic Dissection: a Randomized Controlled Trial

This study is testing if adding nitric oxide to standard treatment can help prevent kidney injury in adults undergoing surgery for aortic dissection.

Quick facts

• Phase: PHASE4
• Study type: Interventional
• Enrollment: 216 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Beijing Anzhen Hospital (other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Beijing, Beijing)
• Trial ID: NCT06622291 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effectiveness of exogenous nitric oxide therapy in reducing acute kidney injury in patients diagnosed with acute type A aortic dissection. The study involves 216 adult participants who are randomly assigned to receive either nitric oxide combined with standard treatment or standard treatment alone during and after surgery. The primary focus is on the incidence of acute kidney injury, while secondary outcomes include various renal function metrics and scores post-surgery. The trial is conducted at Beijing Anzhen Hospital in China.

Who should consider this trial

Good fit: Ideal candidates are adults over 18 years old with a clinical diagnosis of acute type A aortic dissection who are scheduled for surgical intervention.

Not a fit: Patients with pre-existing kidney disease or those requiring renal replacement therapy will not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce the risk of acute kidney injury in patients undergoing surgery for acute type A aortic dissection.

How similar studies have performed: While nitric oxide has been explored in other contexts for kidney protection, this specific application in acute type A aortic dissection is novel and has not been previously tested.

Eligibility criteria

Inclusion Criteria:

1. Provide written informed consent;
2. Participants must be over 18 years of age;
3. Participants should meet the diagnostic and treatment guidelines for thoracic aortic diseases jointly issued by ACC/AHA in 2022, have received clinical and radiological diagnosis of acute type A aortic dissection, and undergone surgical thoracotomy within two weeks after symptom onset.

Exclusion Criteria:

1. Missing baseline value or missing postoperative serum creatinine value (Scr);
2. Preoperative eGFR less than 30ml/min/1.73m2 or receive renal replacement therapy;
3. History of kidney disease, including glomerular diseases: acute glomerulonephritis, rapidly progressive glomerulonephritis, chronic glomerulonephritis, nephrotic syndrome, etc., secondary nephropathy: lupus nephritis, diabetic nephropathy, interstitial nephritis, renal tubular disease, chronic renal failure, renal replacement therapy, etc.;
4. Previous renal tumor, kidney transplantation, and other related surgery;
5. Patients with single kidney;
6. History of malignant tumor or received radiotherapy and chemotherapy;
7. Severe skeletal muscle disease and autoimmune disease;
8. Preoperative dissection rupture or hemodynamic instability (systolic blood pressure \<90mmHg);
9. Life expectancy less than 90 days;
10. Pregnant and lactating women, patients with mental disorders;
11. With intravascular or extravascular hemolytic disease;
12. Have participated in other clinical trials.

Where this trial is running

Beijing, Beijing

• Beijing Anzhen Hospital — Beijing, Beijing, China (RECRUITING)

Conditions: Acute Kidney Injury, Nitrous Oxide, Acute Type a Aortic Dissection, Aortic Dissection, cardiopulmonary bypass