- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07638306
Internal Jugular Vein Ultrasound and Acute Kidney Injury After Abdominal Surgery (PRO-JUGULAR)
Dynamic Internal Jugular Vein Assessment During Anesthesia Induction as a Predictor of Hemodynamic Instability and Postoperative Outcomes
This observational study aims to learn whether changes in the internal jugular vein during anesthesia induction can help predict low blood pressure and kidney injury after surgery. The main questions it aims to answer are:
- Can the internal jugular vein collapsibility index before anesthesia predict low blood pressure during induction?
- Can the change in internal jugular vein collapsibility from before to just after anesthesia predict low blood pressure during surgery and acute kidney injury after surgery?
Participants will have routine ultrasound scans of the neck before anesthesia and again shortly after they fall asleep for surgery. Researchers will also record blood pressure during surgery and measure kidney function after surgery using routine blood tests. and again shortly after they fall asleep for surgery. Researchers will also record blood pressure during surgery and measure kidney function after surgery using routine blood tests.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
This is a single-centre prospective observational study of adults undergoing major abdominal or visceral surgery under general anesthesia. The study is designed to see whether bedside ultrasound measurements of the internal jugular vein can help identify participants who are at risk of low blood pressure during anesthesia induction and acute kidney injury after surgery.
Participants will have one ultrasound scan while awake before anesthesia and a second scan shortly after loss of consciousness following propofol induction. The researchers will calculate the internal jugular vein collapsibility index from both scans and determine the change between them. They will then compare these measurements with blood pressure changes during the induction period and with postoperative kidney function, which will be assessed using routine creatinine tests.
The study includes adults aged 18 years and older who are having elective or urgent non-emergency major abdominal or visceral surgery. Participants must receive propofol for anesthesia induction and must have blood pressure monitoring during surgery. People with emergency surgery, dependence on dialysis, major anatomic abnormalities that prevent ultrasound scanning of the neck, or other conditions that would invalidate the ultrasound measurement will not be included.
The study does not change routine anesthesia care. The ultrasound scans and blood tests are added only for research purposes, and the results are intended to help predict risk rather than guide treatment during the study itself.
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Ubicaciones de estudio
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Mureș County
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Târgu Mureş, Mureș County, Rumania, 540136
- Reclutamiento
- County Emergency Clinical Hospital of Targu Mureș
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Contacto:
- Janos Szederjesi, MD, PhD Assoc Prof
- Número de teléfono: +40745316221
- Correo electrónico: yangzi37@gmail.com
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Contacto:
- Matild Keresztes, MD
- Número de teléfono: 0741784066
- Correo electrónico: keresztesmatild@gmail.com
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- Elective or Urgent (Non-emergent) major abdominal/ visceral surgery under general anesthesia
- General anesthesia with propofol induction (TCI/ manual)
- Expected surgical duration > 60 minutes
- Continous BP monitoring (Invasive arterial line or non-invasive cuff at 2 minute recording intervals)
- Serum creatinine and eGFR (CKD-EPI) available within 30 days prior to surgery
- Written informed consent obtained before surgery
- Patient accessible by phone 30 days postoperatively
Exclusion Criteria:
- Emergency surgery (immediate life-saving, consent unobtainable)
- End-stage renal disease (eGFR < 15 mL/min/1.73 m²) or dialysis-dependent
- Concomitant cardiac surgery or carotid endarterectomy
- Liver transplantation
- Known Internal Jugular Vein/ Inferior Vena Cava thrombosis or Superior Vena Cava syndrome
- Any anatomical neck abnormalities precluding Internal jugular vein ultrasound
- Induction with ketamine or etomidate as sole Induction agent
- Neuraxial anesthesia (spinal or epidural) before propofol induction
- Active decompensated heart failure (NYHA IV or acute pulmonary edema at time of Surgery)
- Same-admission reoperation within 30-day study window
- Withdrawal of consent at any point
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
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Propofol Peri-induction IJV cohort
Prospective observational cohort of adult patients undergoing elective or urgent non-emergent major abdominal or visceral surgery under general anesthesia with propofol induction.
Participants will undergo pre-induction and immediate post-induction internal jugular vein ultrasound measurements to evaluate whether changes in internal jugular vein collapsibility predict post-induction hypotension and postoperative acute kidney injury.
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Point-of-care Internal jugular vein ultrasound performed before induction and immediately after propofol induction to measure vein diameter and collapsibility index.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Post-induction hypotension
Periodo de tiempo: Periprocedural
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Incidence of mean arterial pressure below 65 mmHg for atleast one consecutive minute during propofol induction
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Periprocedural
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Change in Internal Jugular Vein Collapsibility Index
Periodo de tiempo: From pre-induction to immediate post-induction
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Difference between pre-induction and immediate post-induction internal jugular vein collapsibility index measured by point-of-care ultrasound
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From pre-induction to immediate post-induction
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Postoperative Acute Kidney Injury
Periodo de tiempo: Postoperative days one to three
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Acute Kidney Injury defined according to KDIGO criteria based on postoperative serum creatinine measurements
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Postoperative days one to three
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Cumulative Intra-operative Hypotension Burden
Periodo de tiempo: Induction to End of Surgery
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Total duration of mean arterial pressure threshold of 65 mmHg during the operative period
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Induction to End of Surgery
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Cummulative Intra-operative Hypotension burden
Periodo de tiempo: Induction to End of surgery
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Area under the mean arterial pressure threshold of 65 mmHg during the operative period
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Induction to End of surgery
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Colaboradores e Investigadores
Publicaciones y enlaces útiles
Publicaciones Generales
- Salmasi V, Maheshwari K, Yang D, Mascha EJ, Singh A, Sessler DI, Kurz A. Relationship between Intraoperative Hypotension, Defined by Either Reduction from Baseline or Absolute Thresholds, and Acute Kidney and Myocardial Injury after Noncardiac Surgery: A Retrospective Cohort Analysis. Anesthesiology. 2017 Jan;126(1):47-65. doi: 10.1097/ALN.0000000000001432.
- Sessler DI, Bloomstone JA, Aronson S, Berry C, Gan TJ, Kellum JA, Plumb J, Mythen MG, Grocott MPW, Edwards MR, Miller TE; Perioperative Quality Initiative-3 workgroup; POQI chairs; Miller TE, Mythen MG, Grocott MP, Edwards MR; Physiology group; Preoperative blood pressure group; Intraoperative blood pressure group; Postoperative blood pressure group. Perioperative Quality Initiative consensus statement on intraoperative blood pressure, risk and outcomes for elective surgery. Br J Anaesth. 2019 May;122(5):563-574. doi: 10.1016/j.bja.2019.01.013. Epub 2019 Feb 27.
- Yildirim SA, Dogan L, Sarikaya ZT, Ulugol H, Gucyetmez B, Toraman F. Hypotension after Anesthesia Induction: Target-Controlled Infusion Versus Manual Anesthesia Induction of Propofol. J Clin Med. 2023 Aug 14;12(16):5280. doi: 10.3390/jcm12165280.
- Saugel B, Sander M, Kouz K, Habicher M. Association of intraoperative hypotension and cumulative norepinephrine dose with postoperative acute kidney injury in patients having noncardiac surgery. Response to Br J Anaesth 2025; 134: 1552-3. Br J Anaesth. 2025 Jul;135(1):247-248. doi: 10.1016/j.bja.2025.03.035. Epub 2025 May 10. No abstract available.
- Liu J, Lin SH, Zhao YS, Luo RJ, Zhang ZT, Wang LY, Xie K, Fan J, Zhang M, Chai YS, Tang H, Xu F. Incidence and risk factors of acute kidney injury after abdominal surgery: a systematic review and meta-analysis. Ann Med. 2025 Dec;57(1):2547324. doi: 10.1080/07853890.2025.2547324. Epub 2025 Aug 17.
- Okamura K, Nomura T, Mizuno Y, Miyashita T, Goto T. Pre-anesthetic ultrasonographic assessment of the internal jugular vein for prediction of hypotension during the induction of general anesthesia. J Anesth. 2019 Oct;33(5):612-619. doi: 10.1007/s00540-019-02675-9. Epub 2019 Aug 26.
- Sun Z, Wang K, Ji P. Incidence and risk factors for perioperative hypotension during noncardiac surgery: A retrospective cohort study. Medicine (Baltimore). 2026 Jan 9;105(2):e46451. doi: 10.1097/MD.0000000000046451.
Fechas de registro del estudio
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Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
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Palabras clave
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Otros números de identificación del estudio
- 7979
Plan de datos de participantes individuales (IPD)
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Información sobre medicamentos y dispositivos, documentos del estudio
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