SGB Reduces the Incidence and Severity of CSA-AKI

Not Applicable

Completed

• Conditions: Stellate Ganglion Block
• Interventions: Drug: Stellate ganglion block

• Registration Number: NCT05652179
• Lead Sponsor: Yangzhou University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-11-06
• Study First Submitted QC: 2022-12-05
• Study First Posted: 2022-12-15
• Study Start: 2023-01-10
• Primary Completion: 2023-12-01
• Study Completion: 2023-12-30
• Status Verified: 2024-03
• Last Update Submitted: 2025-01-22
• Last Update Posted: 2025-01-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 396

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 < 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Stellate ganglion block	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

Primary Outcome Measures

Name	Time	Method
The incidence and severity of CSA-AKI	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

Secondary Outcome Measures

Name	Time	Method
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	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
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	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.
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	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
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.	The MAP from the radial artery,HR,CVP, and cardiac output.

Trial Locations

Locations (1)

the Affiliated Hospital of Yangzhou University, Yangzhou University; 🇨🇳 Yangzhou, Jiangsu, China