SGB Reduces the Incidence and Severity of CSA-AKI

NCT05652179 | Completed

• 1 other identifier: 20221107
• Study Type: interventional
• Target: 396
• Locations: 1 country
• Sites: 1

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.

Conditions

Stellate Ganglion Block

Keywords

Stellate ganglion block; Cardiac surgery; Acute kidney injury; Sympathetic nerve; Renal artery; Resistance index

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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.

Study Arms (2)

Stellate ganglion block

EXPERIMENTAL

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

Control

NO INTERVENTION

Patients in Group C did not undergo the SGB procedure.

Interventions

Stellate ganglion block DRUG

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.

Stellate ganglion block

Eligibility Criteria

• Age: 18 Years - 80 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yangzhou University: lead

Study Sites (1)

the Affiliated Hospital of Yangzhou University, Yangzhou University

Yangzhou, Jiangsu, China

Location

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 6, 2022
• First Posted: December 15, 2022
• Study Start: January 10, 2023
• Primary Completion: December 1, 2023
• Study Completion: December 30, 2023
• Last Updated: January 23, 2025

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)