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NCT Number: NCT05652179

SGB Reduces the Incidence and Severity of CSA-AKI

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.

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Key information

Conditions

Stellate Ganglion Block Acute Kidney Injury Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

the Affiliated Hospital of Yangzhou University, Yangzhou University

Yangzhou, Jiangsu, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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;
  • 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.

Treatment and study plan

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.

Primary outcomes

  1. 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

  1. Changes of intraoperative left RBF parameters

    Time frame: 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

  2. Changes of perioperative BNP, CK-MB, IL-6, CRP, IL-18, and norepinephrine levels

    Time frame: 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.

  3. Comparison of recovery indicators between the 2 groups

    Time frame: 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

  4. Hemodynamic changes during surgery.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Yangzhou University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Dec 15, 2022
Registry last updated
Jan 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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