SGB Reduces the Incidence and Severity of CSA-AKI

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

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.

Study Overview

• Status: Completed
• Conditions: Stellate Ganglion Block
• Intervention / Treatment: Drug: Stellate ganglion block

• Study Type: Interventional
• Enrollment (Actual): 396
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Yangzhou, Jiangsu, China
      • the Affiliated Hospital of Yangzhou University, Yangzhou University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 38 years to 78 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Ⅱ or Ⅲ.

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	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.
No Intervention: Control; Patients in Group C did not undergo the SGB procedure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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.

Collaborators and Investigators

• Sponsor: Yangzhou University

Study record dates

Study Major Dates

• Study Start (Actual): January 10, 2023
• Primary Completion (Actual): December 1, 2023
• Study Completion (Actual): December 30, 2023

Study Registration Dates

• First Submitted: November 6, 2022
• First Submitted That Met QC Criteria: December 5, 2022
• First Posted (Actual): December 15, 2022

Study Record Updates

• Last Update Posted (Actual): March 26, 2024
• Last Update Submitted That Met QC Criteria: March 22, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Stellate ganglion block; Acute kidney injury; Cardiac surgery; Resistance index; Renal artery; Sympathetic nerve
• Additional Relevant MeSH Terms: Neoplasms; Cysts; Connective Tissue Diseases; Mucinoses; Ganglion Cysts; Synovial Cyst
• Other Study ID Numbers: 20221107

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No