SGB Reduces the Incidence and Severity of CSA-AKI

Stellate Ganglion Block Clinical Trial

Official title:

Pretreatment With Stellate Ganglion Block Reduces the Incidence and Severity of Cardiac Surgery-Associated Acute Kidney Injury

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05652179
• Other study ID #: 20221107
• Status: Completed
• Phase: N/A
• Start date: January 10, 2023
• Est. completion date: December 30, 2023

Study information

• Verified date: March 2024
• Source: Yangzhou University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 396
• Est. completion date: December 30, 2023
• Est. primary completion date: December 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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 ? or ?.

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 < 30%, multi-organ dysfunction;

7. and severe infection requiring continuous antibiotic treatment.

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.

Related Conditions & MeSH terms

• Ganglion Cysts
• Stellate Ganglion Block

Intervention

Drug:
• Stellate ganglion block
After the induction of general anesthesia and before the start of the surgery,ultrasound-guided stellate ganglion block is performed, injecting 5 ml of 0.375% ropivacaine.

Locations

Country	Name	City	State
China	the Affiliated Hospital of Yangzhou University, Yangzhou University	Yangzhou	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Yangzhou University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The incidence and severity of CSA-AKI	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	From the end of surgey to postoperative day 7
Secondary	Changes of intraoperative left RBF parameters	The peak systolic velocity (PSV), end-diastolic velocity (EDV), mean blood flow velocity (V-mean), the diameter of the left renal artery (RAD)and velocity time integral (VTI) of the left renal artery were measured	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
Secondary	Changes of perioperative BNP, CK-MB, IL-6, CRP, IL-18, and norepinephrine levels	Venous blood samples were collected to test BNP (Brain natriuretic peptide), CK-MB (Creatine kinase isoenzymes), kidney injury molecule-1 (KIM-1), interleukin (IL)-6, C-reactive protein (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
Secondary	Comparison of recovery indicators between the 2 groups	The duration of mechanical ventilation in the ICU, length of ICU stay, length of postoperative hospitalization in the ward, and in-hospital mortality were recorded	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
Secondary	Hemodynamic changes during surgery.	The MAP from the radial artery,HR,CVP, and cardiac output.	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.