Pretreatment with Stellate Ganglion Block Reduces the Incidence and Severity of Cardiac Surgery-Associated Acute Kidney Injury
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 396
- 试验地点
- 1
- 主要终点
- The incidence and severity of CSA-AKI
研究概览
简要总结
The incidence of acute kidney injury after cardiopulmonary bypass cardiac surgery is high, which increases postoperative mortality and is not conducive to the prognosis of patients. Stellate ganglion blocks increase renal blood flow, reduce inflammation and stress, and protect the heart muscle. In this study, stellate ganglion block was used to promote rapid recovery of kidney function after cardiopulmonary bypass cardiac surgery.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients of any gender were eligible provided they were between the ages of 18 and 80 years;
- •American Society of Anesthesiologists (ASA) class of Ⅲ or IV.
排除标准
- •emergency cardiac surgery；
- •major vascular surgery；
- •non-sinus rhythm, reoperation；
- •contraindications for TEE or SGB；
- •abnormal preoperative renal function；
- •severe preoperative heart failure with left ventricular ejection fraction < 30%, multi-organ dysfunction；
- •and severe infection requiring continuous antibiotic treatment;
- •enrolled in another clinical trial.
- •Elimination criteria:
- •incomplete follow-up data;
- •withdrawal during the procedure;
- •SGB failure or complications;
- •insufficient ultrasonographic imaging of the left renal artery on TEE;
- •repeated CPB during surgery;
- •need for cardiac assist devices (extracorporeal membrane oxygenation, intra-aortic balloon pump, or ventricular assist devices) after CPB completion.
研究组 & 干预措施
Stellate ganglion block
For patients in Group S, left SGB was performed after the first TEE examination. The patient's head was tilted to the right. A high-frequency probe (6-13 MHz) was placed between the C6 and C7 transverse processes to obtain the best image of the longus colli muscle. After iodine disinfection, a 22-G atraumatic needle for peripheral nerve blocks (B. Braun Melsungen AG, Melsungen, Germany) was used to puncture the site posterior to the left carotid artery and on the surface of the longus colli muscle via an in-plane technique. Then,5 mL of 0.375% ropivacaine hydrochloride injection was administered provided that no blood, cerebrospinal fluid, or gas was suctioned out
干预措施: Stellate ganglion block (Drug)
结局指标
主要结局
The incidence and severity of CSA-AKI
时间窗: From the end of surgey to postoperative day 7
Postoperative serum creatinine was detected once a day from the patient's arrival in the ICU until postoperative day 7. The severity of CSA-AKI was graded by the change in the plasma creatinine levels, according to the Kidney Disease: Improving Global Outcomes (KDIGO) criteria
次要结局
- Changes of intraoperative left RBF parameters(5 minutes after general anesthesia induction,15 minutes after the SGB procedure in Group S and 20 minutes after the completion of the first TEE examination in Group C, and 30 minutes after the end of CPB)
- Changes of perioperative BNP, CK-MB, IL-6, CRP, IL-18, and norepinephrine levels(preoperatively, Immediately after the surgery,the first day after surgery,the second day after surgery, and the seventh day after surgery)
- Comparison of recovery indicators between the 2 groups(From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months)
- Hemodynamic changes during surgery.(after radial artery cannulation,5 min after general anesthesia induction,15 min after the SGB procedure ,30 min after CPB initiation,30 min after the end of CPB,and the end of surgery.)
研究者
Zhuan Zhang
Principal Investigator
Yangzhou University