Clinical trial NCT05652179: SGB Reduces the Incidence and Severity of CSA-AKI
Official title: Pretreatment with Stellate Ganglion Block Reduces the Incidence and Severity of Cardiac Surgery-Associated Acute Kidney Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stellate Ganglion Block
Keywords: Stellate ganglion block
Cardiac surgery
Acute kidney injury
Sympathetic nerve
Renal artery
Resistance index
Lead sponsor: Yangzhou University
Sponsor class: OTHER
First posted: 2022-12-15
Enrollment: 396
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

1. Patients of any gender were eligible provided they were between the ages of 18 and 80 years;
2. American Society of Anesthesiologists (ASA) class of Ⅲ or IV.

Exclusion Criteria:

1. emergency cardiac surgery；
2. major vascular surgery；
3. non-sinus rhythm, reoperation；
4. contraindications for TEE or SGB；
5. abnormal preoperative renal function；
6. severe preoperative heart failure with left ventricular ejection fraction \&lt; 30%, multi-organ dysfunction；
7. and severe infection requiring continuous antibiotic treatment;
8. enrolled in another clinical trial.

Elimination criteria:

1. incomplete follow-up data;
2. withdrawal during the procedure;
3. SGB failure or complications;
4. insufficient ultrasonographic imaging of the left renal artery on TEE;
5. repeated CPB during surgery;
6. need for cardiac assist devices (extracorporeal membrane oxygenation, intra-aortic balloon pump, or ventricular assist devices) after CPB completion.

Primary outcomes:
measure: The incidence and severity of CSA-AKI
timeFrame: From the end of surgey to postoperative day 7
Secondary outcomes:
measure: Changes of intraoperative left RBF parameters
timeFrame: 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
measure: Changes of perioperative BNP, CK-MB, IL-6, CRP, IL-18, and norepinephrine levels
timeFrame: preoperatively, Immediately after the surgery,the first day after surgery,the second day after surgery, and the seventh day after surgery
measure: Comparison of recovery indicators between the 2 groups
timeFrame: 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
measure: Hemodynamic changes during surgery.
timeFrame: 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.
Other outcomes:
Locations:
city: Yangzhou
country: China
facility: the Affiliated Hospital of Yangzhou University, Yangzhou University
state: Jiangsu
Study officials:
References: