Esta página foi traduzida automaticamente e a precisão da tradução não é garantida. Por favor, consulte o versão em inglês para um texto fonte.

Assessment of Renal Perfusion Using Ultrasound and Near-Infrared Spectroscopy in Patients Undergoing Minimally Invasive Abdominal Surgery (RRI-NIRS)

3 de junho de 2026 atualizado por: Lyudmila Martynenko Aydogdu, Istanbul University - Cerrahpasa

Prospective Observational Evaluation of Renal Perfusion Using Doppler Ultrasonography and Near-Infrared Spectroscopy in Patients Undergoing Elective Minimally Invasive Abdominal Surgery

This prospective observational study aims to evaluate renal perfusion in adult patients undergoing elective minimally invasive abdominal surgery. Renal perfusion will be assessed using two non-invasive monitoring techniques: Doppler ultrasonography-derived Renal Resistive Index (RRI) and Near-Infrared Spectroscopy (NIRS)-derived renal regional oxygen saturation (rSO₂).

Measurements will be obtained at predefined perioperative time points, including after induction of anesthesia, during pneumoperitoneum, before extubation, and during the early postoperative period. Perioperative changes in renal perfusion parameters will be analyzed and correlated with clinical variables such as intra-abdominal pressure, pneumoperitoneum duration, hemodynamic parameters, fluid administration, urine output, and postoperative renal function.

The study also aims to investigate the relationship between intraoperative renal perfusion changes and the development of postoperative acute kidney injury. The findings may contribute to improved perioperative monitoring and optimization of renal perfusion during minimally invasive abdominal surgery.

Visão geral do estudo

Descrição detalhada

Minimally invasive abdominal surgery has become increasingly common because of reduced surgical trauma, faster recovery, and lower postoperative morbidity compared with conventional open surgery. However, laparoscopic procedures require the creation of pneumoperitoneum, which may increase intra-abdominal pressure and adversely affect renal blood flow, renal oxygen delivery, and kidney function.

Renal hypoperfusion during surgery may contribute to postoperative renal dysfunction and acute kidney injury (AKI). Traditional indicators of renal injury, such as serum creatinine and urine output, often fail to detect early changes in renal perfusion. Therefore, reliable non-invasive methods for real-time assessment of renal perfusion are needed.

Doppler ultrasonography-derived Renal Resistive Index (RRI) and Near-Infrared Spectroscopy (NIRS)-derived regional renal oxygen saturation (rSO₂) are promising techniques for evaluating renal perfusion and oxygenation. Both methods provide non-invasive, bedside assessment and may allow early detection of perfusion abnormalities before conventional markers become abnormal.

This prospective single-center observational study will evaluate perioperative renal perfusion in adult patients undergoing elective minimally invasive abdominal surgery. Renal perfusion measurements will be obtained using Doppler ultrasonography and NIRS at predefined perioperative time points, including after induction of anesthesia, during pneumoperitoneum, before extubation, and during the early postoperative period.

Demographic characteristics, comorbidities, baseline renal function, intraoperative hemodynamic variables, pneumoperitoneum duration and pressure, fluid administration, urine output, blood loss, ventilatory parameters, and postoperative renal function will be recorded. Associations between perioperative renal perfusion parameters and postoperative renal outcomes, including acute kidney injury, will be investigated.

The findings of this study may improve understanding of perioperative renal perfusion changes during minimally invasive abdominal surgery and contribute to the development of strategies for optimizing renal protection and perioperative patient management

Tipo de estudo

Observacional

Inscrição (Estimado)

51

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Locais de estudo

      • Istanbul, Turquia (Türkiye), 34320
        • Recrutamento
        • Istanbul University Cerrahpasa Faculty of Medicine
        • Contato:

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Não

Método de amostragem

Amostra Não Probabilística

População do estudo

Adult patients aged 18-80 years with ASA physical status I-III undergoing elective minimally invasive abdominal surgery at Istanbul University-Cerrahpaşa Faculty of Medicine. Patients will be prospectively evaluated for perioperative renal perfusion using Doppler ultrasonography and Near-Infrared Spectroscopy (NIRS).

Descrição

Inclusion Criteria:

  • Patients aged 18 to 80 years
  • Patients with ASA physical status I, II, or III
  • Patients undergoing elective minimally invasive abdominal surgery for any reason
  • Patients whose expected surgical duration is longer than 1 hour

Exclusion Criteria:

  • Body mass index greater than 35 kg/m²
  • Severe respiratory system disease
  • Severe heart failure, NYHA class III-IV
  • Presence of a cardiac pacemaker or cardiac defibrillator implant
  • Progressive neuromuscular disease
  • High intra-abdominal pressure
  • Sudden deterioration of general condition
  • Incomplete clinical or laboratory data
  • Refusal to participate in the study
  • Conversion to open surgery

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

Coortes e Intervenções

Grupo / Coorte
Elective Minimally Invasive Abdominal Surgery Patients
Adult patients aged 18 to 80 years undergoing elective minimally invasive abdominal surgery under general anesthesia. Renal perfusion will be assessed perioperatively and postoperatively(postoperative 1. hour) using Doppler ultrasonography-derived Renal Resistive Index (RRI) and Near-Infrared Spectroscopy (NIRS)-derived regional renal oxygen saturation (rSO₂). Measurements will be performed at predefined perioperative time points and correlated with intraoperative variables, postoperative renal function, and the occurrence of acute kidney injury.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Change in Renal Regional Oxygen Saturation Measured by NIRS
Prazo: after endotracheal intubation, immediately before extubation, and 1 hour after extubation
Renal regional oxygen saturation (rSO₂) will be measured bilaterally using Near-Infrared Spectroscopy (NIRS). NIRS values will be recorded at predefined perioperative time points.
after endotracheal intubation, immediately before extubation, and 1 hour after extubation
Change in Renal Resistive Index
Prazo: after endotracheal intubation, immediately before extubation, and 1 hour after extubation
Renal Resistive Index (RRI) measured by Doppler ultrasonography at predefined perioperative time points. RRI will be calculated from peak systolic velocity and end-diastolic velocity obtained from renal interlobar or arcuate arteries.
after endotracheal intubation, immediately before extubation, and 1 hour after extubation

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Relationship Between Renal Resistive Index and Renal Regional Oxygen Saturation
Prazo: after endotracheal intubation, immediately before extubation, and 1 hour after extubation
The relationship between renal Doppler ultrasonography-derived Renal Resistive Index (RRI) and NIRS-derived renal regional oxygen saturation (rSO₂) will be evaluated for the right and left kidneys at predefined perioperative measurement time points.
after endotracheal intubation, immediately before extubation, and 1 hour after extubation

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

7 de janeiro de 2026

Conclusão Primária (Estimado)

7 de janeiro de 2027

Conclusão do estudo (Estimado)

7 de janeiro de 2027

Datas de inscrição no estudo

Enviado pela primeira vez

3 de junho de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

3 de junho de 2026

Primeira postagem (Real)

9 de junho de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

9 de junho de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

3 de junho de 2026

Última verificação

1 de junho de 2026

Mais Informações

Termos relacionados a este estudo

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Descrição do plano IPD

Individual participant data (IPD) will not be shared because the study was not designed with a data-sharing plan and participant confidentiality will be protected in accordance with institutional and ethical requirements.

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

Se inscrever