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

3 giugno 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Descrizione dettagliata

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 di studio

Osservativo

Iscrizione (Stimato)

51

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

  • Turchia (Türkiye)
      • Istanbul, Turchia (Türkiye), 34320
        • Reclutamento
        • Istanbul University Cerrahpasa Faculty of Medicine
        • Contatto:

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

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).

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Coorti e interventi

Gruppo / 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in Renal Regional Oxygen Saturation Measured by NIRS
Lasso di tempo: 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
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Relationship Between Renal Resistive Index and Renal Regional Oxygen Saturation
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Istanbul University - Cerrahpasa

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

7 gennaio 2026

Completamento primario (Stimato)

7 gennaio 2027

Completamento dello studio (Stimato)

7 gennaio 2027

Date di iscrizione allo studio

Primo inviato

3 giugno 2026

Primo inviato che soddisfa i criteri di controllo qualità

3 giugno 2026

Primo Inserito (Effettivo)

9 giugno 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

9 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

3 giugno 2026

Ultimo verificato

1 giugno 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • CUC-RenalPerfusion-2026

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Descrizione del piano 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.

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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