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
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 106
- 试验地点
- 2
- 主要终点
- Acute kidney injury (AKI)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provide written informed consent;
- •Participants must be over 18 years of age;
- •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.
排除标准
- •Missing baseline value or missing postoperative serum creatinine value (Scr);
- •Preoperative eGFR less than 30ml/min/1.73m2 or receive renal replacement therapy;
- •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.;
- •Previous renal tumor, kidney transplantation, and other related surgery;
- •Patients with single kidney;
- •History of malignant tumor or received radiotherapy and chemotherapy;
- •Severe skeletal muscle disease and autoimmune disease;
- •Preoperative dissection rupture or hemodynamic instability (systolic blood pressure <90mmHg);
- •Life expectancy less than 90 days;
- •Pregnant and lactating women, patients with mental disorders;
- •With intravascular or extravascular hemolytic disease;
- •Have participated in other clinical trials.
研究组 & 干预措施
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.
干预措施: Nitric Oxide (Drug)
Usual care
Patients in this group receive a sham treatment without the supply of nitric oxide during CPB and for 12 hours post-operation.
干预措施: Placebo (Other)
结局指标
主要结局
Acute kidney injury (AKI)
时间窗: 48 hours
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.
次要结局
- AKI grade(48 hours after surgery)
- Vasoactive-inotropic score(immediate admission to ICU, 12 and 24 hours after surgery)
- Neutrophil gelatinase-associated lipocalin concentration(before surgery, immediate ICU admission, 12 and 24 hours after surgery)
- Multiple organ failure(24 hours after surgery)
- Duration of mechanical ventilation (hours)(90 days after surgery)
- Duration of non-invasive ventilation and High flow oxygen therapy(90 days after surgery)
- ICU stay(90 days after surgery)
- Hospital stay(90 days after surgery)
- Major Adverse Kidney Events(90 days after surgery)
- Postoperative pleural and pericardial drainage(24 hours after surgery)
- Urine output(During CPB surgery, 12 and 24 hours after surgery)
研究者
chenzheyuan
MD
Beijing Anzhen Hospital