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| ID | Type | Description | Link |
|---|---|---|---|
| Z191100006619095 | Other Grant/Funding Number | Beijing Municipal Science & Technology Commission | |
| 2025AZB6001 | Other Grant/Funding Number | Beijing Anzhen Hospital High Level Research Funding |
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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.
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 106 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) within 48 hours after surgery. The secondary endpoints include AKI grade (KDIGO); urine volume during CPB, 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nitric Oxide | Experimental | 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. |
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| Usual care | Placebo Comparator | Patients in this group receive a sham treatment without the supply of nitric oxide during CPB and for 12 hours post-operation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nitric Oxide | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Acute kidney injury (AKI) | Incidence of Acute Kidney injury. The presence of acute kidney injury (AKI) is assessed during 48 hours after surgery. AKI is defined as follows: an increase in serum creatinine ≥ 0.3 mg/dL (≥ 26.5 μM/L) during 48 hours after surgery; or an increase in serum creatinine by ≥ 1.5 times compared with the initial preoperative level for seven days after intervention; or urine output < 0.5 mL/kg/h for 6 hours during the first 48 h after surgery. | 48 hours |
| Measure | Description | Time Frame |
|---|---|---|
| AKI grade | Grade I: an increase in serum creatinine ≥ 0.3 mg/dL (≥ 26.5 μM/L) during 48 hours after surgery; or an increase in serum creatinine by ≥ 1.5 times compared with the initial preoperative level for seven days after the intervention; or urine output < 0.5 mL/kg/h for 6 hours during the first 48 h after surgery. Grade II: an increase in serum creatinine by 2-2.9 times compared with the initial preoperative level for seven days after the intervention. Grade III: an increase in serum creatinine by ≥ 3 times compared with the initial preoperative level for seven days after the intervention; or an increase in serum creatinine ≥ 4.0 mg/dL (≥ 353.6 μM/L) during 48 hours after surgery; or start RRT. |
| Measure | Description | Time Frame |
|---|---|---|
| Dose of diuretics and recombinant human brain natriuretic peptide | The dosage of diuretics and recombinant human brain natriuretic peptide used during CPB and within 24 hours after surgery will be recorded. | During CPB surgery, 12 and 24 hours after surgery |
| Transfusions |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Anzhen Hospital | Beijing | Beijing Municipality | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40790609 | Derived | 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. |
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Deidentified individual participant data (text, tables, figures, and appendices), underlying the results of the trial, will be shared with researchers to achieve the aims in the approved proposal.
Proposals may be submitted up to 6 months following publication of the results of the trial.
Information regarding submitting proposals and accessing data may be requested from the principal investigator by e-mail.
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| ID | Term |
|---|---|
| D058186 | Acute Kidney Injury |
| D000784 | Aortic Dissection |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| D009569 | Nitric Oxide |
| ID | Term |
|---|---|
| D026361 | Reactive Nitrogen Species |
| D005609 | Free Radicals |
| D007287 | Inorganic Chemicals |
| D009589 | Nitrogen Oxides |
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Single-center prospective, randomized, placebo-controlled study
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| Placebo | 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. |
|
| 48 hours after surgery |
| Urine output | Urine output values (mL/kg/h) are assessed during CPB and 24 hours after surgery. | During CPB surgery, 12 and 24 hours after surgery |
| Vasoactive-inotropic score | Difference between groups of vasoactive-inotropic score. VIS is calculated as Dopamine dose (mg/kg/min) + Dobutamine dose (mg/kg/min) + 100 x Epinephrine dose (mg/kg/min) + 100 x Norepinephrine dose (mg/kg/min) + 10 x Milrinone dose (mg/kg/min) + 10,000 x Vasopressin dose (units/kg/min). | immediate admission to ICU, 12 and 24 hours after surgery |
| Neutrophil gelatinase-associated lipocalin concentration | Neutrophil gelatinase-associated lipocalin concentrations will be measured in the two groups. | before surgery, immediate ICU admission, 12 and 24 hours after surgery |
| Multiple organ failure | Assessment of multiple organ failure through the Sequential organ failure score. The scoring system is mainly divided into 6 parts, namely respiratory function, coagulation function, liver, cardiovascular system, central nervous system, and renal function. The scores range from 0 to 4, with a score of 0 indicating normal function in all organs. The higher the score, the worse the prognosis. | 24 hours after surgery |
| Duration of mechanical ventilation (hours) | Difference of duration of mechanical ventilation defined as number of hours. | 90 days after surgery |
| Duration of non-invasive ventilation and High flow oxygen therapy | Difference of duration of non-invasive ventilation and high flow oxygen therapy defined as number of hours. | 90 days after surgery |
| ICU stay | Difference between groups of intensive care unit length of stay defined as number of days. | 90 days after surgery |
| Hospital stay | Difference between groups of hospital length of stay defined as number of days. | 90 days after surgery |
| Major Adverse Kidney Events | Difference between groups of major adverse kidney events at 90 days after surgery. MAKE is a composite outcome of death, new dialysis and worsened renal function (defined as a 25% or greater decline in eGFR compared to the baseline). | 90 days after surgery |
| Postoperative pleural and pericardial drainage | Difference values between groups of postoperative pleural and pericardial drainage. | 24 hours after surgery |
Differences between the two groups of transfusions with plasma and stored or autologous red blood cells (RBCs) recovered using intraoperative cell salvage devices. |
| 24 hours after surgery |
| Renal Ultrasound | Blood flow grade in renal ultrasound at ICU admission immediately, 12 and 24 hours after surgery | immediate admission to ICU, 12 and 24 hours after surgery |
| Renal Ultrasound | Pulsatility index in renal ultrasound at ICU admission immediately, 12 and 24 hours after surgery | immediate admission to ICU, 12 and 24 hours after surgery |
| Renal Ultrasound | Resistance index in renal ultrasound at ICU admission immediately, 12 and 24 hours after surgery | immediate admission to ICU, 12 and 24 hours after surgery |
| Free hemoglobin concentration measure | Blood free hemoglobin concentrations will be measured in the two groups. | before surgery, immediate admission to ICU, 12 and 24 hours after surgery |
| methemoglobin concentration measure | Blood methemoglobin concentrations will be measured in the two groups. | before surgery, immediate admission to ICU, 12 and 24 hours after surgery |
| Nitric oxide metabolite concentration measure | The two groups will measure the concentration of nitric oxide metabolites: nitrite (NO2-) and the total of NO metabolites (NOt). | before surgery, immediate admission to ICU, 12 and 24 hours after surgery |
| Oxygenation index | Difference between groups in oxygenation index. | before surgery, immediate admission to ICU, 12 and 24 hours after surgery |
| Near-renal infrared oxygen saturation | Difference between groups in near-renal infrared oxygen saturation. | immediate admission to ICU, 12 and 24 hours after surgery |
| CVP | Differences in values (mmHg) between the two groups of CVP . | before surgery, end of surgery, immediate admission to ICU, 8, 12, 24 hours after surgery |
| PEEP | Differences in values （cmH2O） between the two groups of PEEP. | before surgery, end of surgery, immediate admission to ICU, 8, 12, 24 hours after surgery |
| Inflammation related indicators | Levels of inflammation-related indicators, including the neutrophil lymphocyte ratio(NLR), and the platelet lymphocyte ratio(PLR), will be measured in the two groups. | before surgery, immediate admission to ICU, 12 and 24 hours after surgery |
| Inflammation related indicators | Levels of inflammation-related indicators, including the systemic inflammatory response index(SIRI), and the systemic immune response index(SII) will be measured in the two groups. | before surgery, immediate admission to ICU, 12 and 24 hours after surgery |
| Inflammation related indicators | Levels of inflammation-related indicators, including white blood cell (WBC) will be measured in the two groups. | before surgery, immediate admission to ICU, 12 and 24 hours after surgery |
| Oxidative stress related indicators | Levels of oxidative stress-related indicators, including Malondialdehyde (MDA) and superoxide dismutase (SOD) will be measured in the two groups. | before surgery, immediate admission to ICU, 12 and 24 hours after surgery |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D000094665 | Dissection, Blood Vessel |
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D000094683 | Acute Aortic Syndrome |
| D001018 | Aortic Diseases |
| D017672 |
| Nitrogen Compounds |
| D010087 | Oxides |
| D017601 | Oxygen Compounds |
| D009930 | Organic Chemicals |