Skip to main content
Clinical Trials/NCT05652179
NCT05652179
Completed
Not Applicable

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

Yangzhou University1 site in 1 country396 target enrollmentJanuary 10, 2023

Overview

Phase
Not Applicable
Intervention
Stellate ganglion block
Conditions
Stellate Ganglion Block
Sponsor
Yangzhou University
Enrollment
396
Locations
1
Primary Endpoint
The incidence and severity of CSA-AKI
Status
Completed
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 10, 2023
End Date
December 30, 2023
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Yangzhou University
Responsible Party
Principal Investigator
Principal Investigator

Zhuan Zhang

Principal Investigator

Yangzhou University

Eligibility Criteria

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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;

Arms & Interventions

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

Intervention: Stellate ganglion block

Outcomes

Primary Outcomes

The incidence and severity of CSA-AKI

Time Frame: 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 Outcomes

  • 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 Sites (1)

Loading locations...

Similar Trials