Perioperative Nitric Oxide Prevents Acute Kidney Injury in Acute Type A Aortic Dissection Patients

NCT ID: NCT06622291

Last Updated: 2025-11-26

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 216 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-30
• Study Completion Date: 2026-06-01

Brief Summary

The goal of this clinical trial is to determine the effectiveness of exogenous nitric oxide therapy in reducing the occurrence of acute kidney injury in patients with acute type A aortic dissection. Additionally, it aims to assess the safety of exogenous nitric oxide therapy.

Detailed Description

The incidence of acute kidney injury following acute type A aortic dissection is significantly high, thereby exerting a substantial impact on patient prognosis. Nitric oxide, an endogenous gaseous molecule with potential therapeutic effects, has been investigated in clinical studies as a treatment for acute kidney injury following cardiac surgery. However, there is currently no clinical study exploring the application of nitric oxide in patients with acute type A aortic dissection. Therefore, this study aims to investigate whether exogenous nitric oxide therapy has renal protective effects and its mechanism.

This prospective randomized study is conducted at Beijing Anzhen Hospital in Beijing, China. A total of 216 adult patients with acute type A aortic dissection are enrolled in this study. The patients are randomly divided into two groups: the experimental group received NO combined with conventional treatment, and the control group is only given conventional treatment. In the experimental group, 60 ppm NO is administered during intraoperative CPB and continued until within 12 hours after surgery.

The primary endpoint is the incidence of acute kidney injury (AKI). The secondary endpoints include AKI grade (KDIGO); urine volume during surgery, within 12 and 24 hours after surgery; blood flow grade, resistance index, and pulsatility index in renal ultrasound at ICU admission, 12 and 24 hours after surgery; SOFA score at 24 hours after surgery; VIS score at ICU admission, 12 and 24 hours after surgery; duration of mechanical ventilation, non-invasive ventilation, and high-flow oxygen therapy; length of ICU stay and hospital stay; renal adverse events within 90 days; volume of drainage from the pleural and pericardial cavities after surgery. Additionally, dosage of diuretics and recombinant human brain natriuretic peptide during surgery and within 48 hours after surgery; oxygenation index and near-renal infrared oxygen saturation; levels of free hemoglobin, methemoglobin, nitrite (NO2-) and the total of NO metabolites (NOt); neutrophil gelatinase-associated lipocalin concentration; levels of the neutrophils lymphocytes ratio (NLR), the platelet lymphocyte ratio (PLR), systemic inflammatory response index (SIRI), and systemic immune response index (SII) ; CVP and PEEP, the volume of transfusions with plasma and stored or autologous RBCs will also be measured in both groups.

Conditions

Acute Kidney Injury; Nitrous Oxide; Acute Type A Aortic Dissection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Nitric Oxide

Patients in this group receive treatment with exogenous nitric oxide (NO) via the CPB machine. After CPB, NO is administered through the inspiratory limb of the anesthetic or ventilator circuit and then via the mechanical ventilator in the ICU. Once patients are extubated, they will breathe NO through a facemask or nasal cannula. NO administration begins at the start of CPB and continues for 12 hours post-operation.

Group Type: EXPERIMENTAL

Nitric Oxide

Intervention Type: DRUG

Exogenous nitric oxide is directly administered to the oxygenator in the cardiopulmonary bypass circuit at a concentration of 60 ppm. Nitric oxide is also directly administered to the ventilator at a concentration of 60 ppm for 12 hours post-operation.

Usual care

Patients in this group receive a sham treatment without the supply of nitric oxide during CPB and for 12 hours post-operation.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

This is the placebo group. The standard CPB protocol involves delivering an air-gas mixture to the cardiopulmonary bypass circuit during cardiac surgery and avoiding the use of nitric oxide within 12 hours after surgery.

Interventions

Nitric Oxide

Exogenous nitric oxide is directly administered to the oxygenator in the cardiopulmonary bypass circuit at a concentration of 60 ppm. Nitric oxide is also directly administered to the ventilator at a concentration of 60 ppm for 12 hours post-operation.

Intervention Type: DRUG

Placebo

This is the placebo group. The standard CPB protocol involves delivering an air-gas mixture to the cardiopulmonary bypass circuit during cardiac surgery and avoiding the use of nitric oxide within 12 hours after surgery.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beijing Anzhen Hospital

OTHER

Sponsor Role: lead

Responsible Party

chenzheyuan

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Beijing Anzhen Hospital

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Facility Contacts

Zheyuan Chen

Role: primary

chenzheyuan@mail.ccmu.edu.cn

86+64456140

References

Chen Z, Han X, Li L, Liu M, Yu L, Cheng S, Yu Y, Liu N. Nitric oxide for the prevention of postoperative acute kidney injury in patients undergoing surgery for Stanford type A aortic dissection: study protocol for a randomized controlled trial. Trials. 2025 Aug 11;26(1):284. doi: 10.1186/s13063-025-08986-5.

Reference Type: DERIVED

PMID: 40790609 (View on PubMed)

Other Identifiers

Z191100006619095

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

2024-16-20240626

Identifier Type: -

Identifier Source: org_study_id