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Internal Jugular Vein Ultrasound and Acute Kidney Injury After Abdominal Surgery (PRO-JUGULAR)

7 de septiembre de 2026 actualizado por: Matild Keresztes, Tîrgu Mureș Emergency Clinical County Hospital, Romania

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:

  1. Can the internal jugular vein collapsibility index before anesthesia predict low blood pressure during induction?
  2. 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

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

De observación

Inscripción (Estimado)

150

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

    • Mureș County
      • Târgu Mureş, Mureș County, Rumania, 540136
        • Reclutamiento
        • County Emergency Clinical Hospital of Targu Mureș
        • Contacto:
          • Janos Szederjesi, MD, PhD Assoc Prof
          • Número de teléfono: +40745316221
          • Correo electrónico: yangzi37@gmail.com
        • Contacto:

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

Método de muestreo

Muestra de probabilidad

Población de estudio

The study population consists of adults aged 18 years and older undergoing major abdominal or visceral surgery under general anesthesia with propofol induction at the Department of Anestesiology and Intensive Care Department in the Emergency County Hospital in Târgu Mureș. Patients will be enrolled prospectively in the preoperative period if they meet eligibility criteria, have routine perioperative blood pressure monitoring, and are able to undergo internal jugular vein ultrasound before and immediately after induction. The cohort will be followed through postoperative days 1 to 3 for creatinine-based assessment of acute kidney injury.

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

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

Cohortes e Intervenciones

Grupo / Cohorte
Intervención / Tratamiento
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.
Point-of-care Internal jugular vein ultrasound performed before induction and immediately after propofol induction to measure vein diameter and collapsibility index.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Post-induction hypotension
Periodo de tiempo: Periprocedural
Incidence of mean arterial pressure below 65 mmHg for atleast one consecutive minute during propofol induction
Periprocedural
Change in Internal Jugular Vein Collapsibility Index
Periodo de tiempo: From pre-induction to immediate post-induction
Difference between pre-induction and immediate post-induction internal jugular vein collapsibility index measured by point-of-care ultrasound
From pre-induction to immediate post-induction

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Postoperative Acute Kidney Injury
Periodo de tiempo: Postoperative days one to three
Acute Kidney Injury defined according to KDIGO criteria based on postoperative serum creatinine measurements
Postoperative days one to three
Cumulative Intra-operative Hypotension Burden
Periodo de tiempo: Induction to End of Surgery
Total duration of mean arterial pressure threshold of 65 mmHg during the operative period
Induction to End of Surgery

Otras medidas de resultado

Medida de resultado
Medida Descripción
Periodo de tiempo
Cummulative Intra-operative Hypotension burden
Periodo de tiempo: Induction to End of surgery
Area under the mean arterial pressure threshold of 65 mmHg during the operative period
Induction to End of surgery

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Publicaciones y enlaces útiles

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Publicaciones Generales

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

7 de septiembre de 2026

Finalización primaria (Estimado)

31 de enero de 2027

Finalización del estudio (Estimado)

28 de marzo de 2027

Fechas de registro del estudio

Enviado por primera vez

21 de mayo de 2026

Primero enviado que cumplió con los criterios de control de calidad

4 de junio de 2026

Publicado por primera vez (Actual)

10 de junio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

10 de septiembre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

7 de septiembre de 2026

Última verificación

1 de septiembre de 2026

Más información

Términos relacionados con este estudio

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

INDECISO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

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