- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07635160
Assessment of Renal Perfusion Using Ultrasound and Near-Infrared Spectroscopy in Patients Undergoing Minimally Invasive Abdominal Surgery (RRI-NIRS)
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.
Study Overview
Status
Detailed Description
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
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Lyudmila MARTYNENKO AYDOGDU, M.D.
- Phone Number: +90 5300613611
- Email: lyudmila.lylyly1@gmail.com
Study Locations
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Istanbul, Turkey (Türkiye), 34320
- Recruiting
- Istanbul University Cerrahpaşa Faculty of Medicine
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Contact:
- Lyudmila MARTYNENKO AYDOGDU, M.D.
- Phone Number: +90 5300613611
- Email: lyudmila.lylyly1@gmail.com
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change in Renal Regional Oxygen Saturation Measured by NIRS
Time Frame: after endotracheal intubation, immediately before extubation, and 1 hour after extubation
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Renal regional oxygen saturation (rSO₂) will be measured bilaterally using Near-Infrared Spectroscopy (NIRS).
NIRS values will be recorded at predefined perioperative time points.
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after endotracheal intubation, immediately before extubation, and 1 hour after extubation
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Change in Renal Resistive Index
Time Frame: after endotracheal intubation, immediately before extubation, and 1 hour after extubation
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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.
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after endotracheal intubation, immediately before extubation, and 1 hour after extubation
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Relationship Between Renal Resistive Index and Renal Regional Oxygen Saturation
Time Frame: after endotracheal intubation, immediately before extubation, and 1 hour after extubation
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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.
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after endotracheal intubation, immediately before extubation, and 1 hour after extubation
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CUC-RenalPerfusion-2026
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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