Liver Transplant, ComplicationsNCT07409532
Intraoperative Assessment of Renal Tissue Oxygenation Using NIRS
An observational study of Liver Transplant, Complications and Renal Failure Acute Chronic, run by Inonu University at 1 site in Turkey (Türkiye).
Trial summary
The kidney is one of the most vital organs in the human body. Renal perfusion is primarily supplied by the renal artery, while the removal of metabolites and venous drainage are provided by the renal vein. Although anatomical variations may exist, the renal artery typically originates from the abdominal aorta. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Liver Transplant, Complications, Renal Failure Acute Chronic
- Type of treatment
- Injection or infusion
- How many people
- 41 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2022to 7 Aug 2025
- How long will I take part?
- 7 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing elective liver transplantation between the ages of 18 and 65
Who may be able to join
- Patients aged 18-65 scheduled for elective liver transplantation.
- American Society of Anesthesiologists (ASA) physical status III-IV were enrolled.
Who cannot join
- Patients undergoing emergency liver transplantation,
- Advanced preexisting renal dysfunction
- İndividuals with significant cardiovascular instability
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Inonu University Liver Transplant Institute
Malatya, 44280
About this study
Official title: Intraoperative Assessment of Renal Tissue Oxygenation Using Near-Infrared Spectroscopy During Liver Transplantation and Its Relationship With Hemodynamic Parameters: A Prospective Observational Study
The kidney is one of the most vital organs in the human body. Renal perfusion is primarily supplied by the renal artery, while the removal of metabolites and venous drainage are provided by the renal vein. Although anatomical variations may exist, the renal artery typically originates from the abdominal aorta. In patients undergoing liver transplantation, renal function may be affected by multiple factors. Impairment of renal function significantly influences postoperative mortality, morbidity, graft survival, and length of hospital stay.
Intraoperative assessment of renal perfusion has traditionally relied on monitoring hourly urine output and serum renal function tests. However, these methods may be insufficient and delayed in evaluating renal function, particularly during clamping of the inferior vena cava for hepatic graft venous anastomosis. Although Doppler ultrasonography can provide information regarding blood flow, it does not offer direct insight into the adequacy of tissue perfusion.
Read more
Near-infrared spectroscopy (NIRS) is a non-invasive technique that has gained increasing attention in recent years due to its ability to accurately assess tissue oxygenation. Based on the Beer-Lambert law, NIRS enables the measurement of tissue oxygen saturation without the need for invasive procedures. The technique requires no intervention and is not associated with known complications or adverse effects.
NIRS is most commonly used in clinical practice to assess cerebral oxygenation via measurements obtained from the frontal region. The aim of the present study is to evaluate renal oxygenation using near-infrared spectroscopy and to determine whether this technique provides clinically useful information during the liver transplantation procedure.
Read the detailed description
Near-infrared spectroscopy (NIRS) is a non-invasive and user-friendly technique that enables real-time monitoring of tissue oxygen content. It is most commonly used in clinical practice to assess cerebral tissue oxygenation, particularly in cardiac surgery, where significant hemodynamic fluctuations are frequently encountered. NIRS measures cerebral tissue oxygen saturation from the frontal region and reflects the balance between local cerebral oxygen supply and demand. Light applied to the forehead is emitted within the near-infrared spectrum and detected by sensors positioned at specific distances from the light source. Using a modified version of the Beer-Lambert law, NIRS provides a measurement of oxygenated hemoglobin concentration relative to total hemoglobin concentration. Algorithms are subsequently applied to the raw data to generate a quantitative estimate of tissue oxygen saturation.
Numerous studies have demonstrated a correlation between cerebral desaturation and postoperative neurological complications. Consequently, specific management algorithms have been developed for the use of NIRS in cardiac surgery. In the presence of cerebral desaturation, recommended interventions include correction of cannula positioning, elevation of mean arterial pressure, increasing the inspired oxygen concentration, normalization of PaCO₂ levels, correction of hemoglobin concentration, augmentation of cardiac output, and reduction of cerebral metabolic rate.
Renal oxygen supply is primarily provided via the renal artery, while venous drainage occurs through the renal veins into the inferior vena cava. Adequate renal perfusion during liver transplantation is essential to minimize postoperative renal complications. For vascular anastomosis of the liver graft, clamping of the inferior vena cava is required, a process that results in significant hemodynamic alterations and impaired renal venous drainage. These changes may substantially affect renal oxygenation and perfusion. Although renal blood flow adequacy can be indirectly assessed by monitoring urine output after reperfusion, this method does not allow for objective evaluation of renal tissue oxygenation. We hypothesize that intraoperative monitoring of renal tissue oxygenation using NIRS may provide valuable real-time information and contribute to the early identification of postoperative acute kidney injury.
- Keywords
- NIRS, Liver Transplantation, Renal Function
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group1 | A total of 41 adult patients (≥18 years) scheduled for elective orthotopic liver transplantation (OLT) and classified as American Society of Anesthesiologists (ASA) physical status III-IV were enrolled to study between 2024 and 2025 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Renal O3
Renal parenchymal oxygen saturation was measured using a Masimo™ NIRS probe enclosed in a sterile sheath. During surgical dissection, the probe was positioned vertically on the Gerota's fascia overlying the kidney.
Measured: Measurements were recorded at three predefined surgical phases: • T0: Pre-anhepatic phase (beginning of dissection) • T1: Anhepatic phase (after clamping of the inferior vena cava and portal vein) • T2: Neohepatic phase (after graft reperfusion and compl
Cr
Renal function was evaluated using serum creatinine levels
Measured: Renal function was evaluated using serum creatinine levels measured preoperatively, at postoperative 24 hours, and at postoperative week 1.
Secondary outcomes (4)
HR
Heart Rate
Measured: During surgery: • T0: Pre-anhepatic phase (beginning of dissection) • T1: Anhepatic phase (after clamping of the inferior vena cava and portal vein) • T2: Neohepatic phase (after graft reperfusion and completion of vascular anastomoses)
MAP
mean arterial pressure (mmHg) (via invasive arterial pressure monitoring from the radial artery)
Measured: During surgery: • T0: Pre-anhepatic phase (beginning of dissection) • T1: Anhepatic phase (after clamping of the inferior vena cava and portal vein) • T2: Neohepatic phase (after graft reperfusion and completion of vascular anastomoses)
CI
Cardiac Index (L/min/m²) (via PICCO flotrac monitoring platform)
Measured: During surgery: • T0: Pre-anhepatic phase (beginning of dissection) • T1: Anhepatic phase (after clamping of the inferior vena cava and portal vein) • T2: Neohepatic phase (after graft reperfusion and completion of vascular anastomoses)
SVV
Stroke volume variation (%) (via PICCO flotrac monitoring platform)
Measured: During surgery: • T0: Pre-anhepatic phase (beginning of dissection) • T1: Anhepatic phase (after clamping of the inferior vena cava and portal vein) • T2: Neohepatic phase (after graft reperfusion and completion of vascular anastomoses)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2026
- Study start1 Dec 2022
- Primary completion15 Jul 2024
- Study completion7 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Liver Transplant, ComplicationsStudies of the same condition, open and under way.
- More trials run by Inonu UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 41 participants (actual)
- Target duration
- 7 Days
Sponsor and investigators
- Lead sponsor
- Inonu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yusuf Ziya ÇOLAK, Inonu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07409532
- Sponsor's protocol ID
- Inonu Kidney03
- Status last verified
- Jul 2024
- First submitted
- 2 Feb 2026
- Last updated
- 13 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Demographic data including age, sex, and body mass index (BMI), as well as comorbidities, duration of surgery, and length of intensive care unit (ICU) stay, HR, MAP, Renal O3, creatin values
Publications
Bevan PJ. Should Cerebral Near-infrared Spectroscopy be Standard of Care in Adult Cardiac Surgery? Heart Lung Circ. 2015 Jun;24(6):544-50. doi: 10.1016/j.hlc.2015.01.011. Epub 2015 Feb 7.
PubMed 25735719Fischer GW, Silvay G. Cerebral oximetry in cardiac and major vascular surgery. HSR Proc Intensive Care Cardiovasc Anesth. 2010;2(4):249-56.
PubMed 23439275Edmonds HL Jr. Pro: all cardiac surgical patients should have intraoperative cerebral oxygenation monitoring. J Cardiothorac Vasc Anesth. 2006 Jun;20(3):445-9. doi: 10.1053/j.jvca.2006.03.003. No abstract available.
PubMed 16750751
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraoperative Assessment of Renal Tissue Oxygenation Using Near-Infrared Spectroscopy During Liver Transplantation and Its Relationship With Hemodynamic Parameters: A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT07409532
- Acronym / sponsor ID
- Inonu Kidney03
- Keywords
- NIRS, Liver Transplantation, Renal Function
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Inonu UniversityUniversity, hospital or other
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 15 Jul 2024 (actual)
- Study completion
- 7 Aug 2025 (actual)
- First posted
- 13 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The kidney is one of the most vital organs in the human body. Renal perfusion is primarily supplied by the renal artery, while the removal of metabolites and venous drainage are provided by the renal vein. Although anatomical variations may exist, the renal artery typically originates from the abdominal aorta. In patients undergoing liver transplantation, renal function may be affected by multiple factors. Impairment of renal function significantly influences postoperative mortality, morbidity, graft survival, and length of hospital stay.
Intraoperative assessment of renal perfusion has traditionally relied on monitoring hourly urine output and serum renal function tests. However, these methods may be insufficient and delayed in evaluating renal function, particularly during clamping of the inferior vena cava for hepatic graft venous anastomosis. Although Doppler ultrasonography can provide information regarding blood flow, it does not offer direct insight into the adequacy of tissue perfusion.
Near-infrared spectroscopy (NIRS) is a non-invasive technique that has gained increasing attention in recent years due to its ability to accurately assess tissue oxygenation. Based on the Beer-Lambert law, NIRS enables the measurement of tissue oxygen saturation without the need for invasive procedures. The technique requires no intervention and is not associated with known complications or adverse effects.
NIRS is most commonly used in clinical practice to assess cerebral oxygenation via measurements obtained from the frontal region. The aim of the present study is to evaluate renal oxygenation using near-infrared spectroscopy and to determine whether this technique provides clinically useful information during the liver transplantation procedure.
Detailed description
Near-infrared spectroscopy (NIRS) is a non-invasive and user-friendly technique that enables real-time monitoring of tissue oxygen content. It is most commonly used in clinical practice to assess cerebral tissue oxygenation, particularly in cardiac surgery, where significant hemodynamic fluctuations are frequently encountered. NIRS measures cerebral tissue oxygen saturation from the frontal region and reflects the balance between local cerebral oxygen supply and demand. Light applied to the forehead is emitted within the near-infrared spectrum and detected by sensors positioned at specific distances from the light source. Using a modified version of the Beer-Lambert law, NIRS provides a measurement of oxygenated hemoglobin concentration relative to total hemoglobin concentration. Algorithms are subsequently applied to the raw data to generate a quantitative estimate of tissue oxygen saturation.
Numerous studies have demonstrated a correlation between cerebral desaturation and postoperative neurological complications. Consequently, specific management algorithms have been developed for the use of NIRS in cardiac surgery. In the presence of cerebral desaturation, recommended interventions include correction of cannula positioning, elevation of mean arterial pressure, increasing the inspired oxygen concentration, normalization of PaCO₂ levels, correction of hemoglobin concentration, augmentation of cardiac output, and reduction of cerebral metabolic rate.
Renal oxygen supply is primarily provided via the renal artery, while venous drainage occurs through the renal veins into the inferior vena cava. Adequate renal perfusion during liver transplantation is essential to minimize postoperative renal complications. For vascular anastomosis of the liver graft, clamping of the inferior vena cava is required, a process that results in significant hemodynamic alterations and impaired renal venous drainage. These changes may substantially affect renal oxygenation and perfusion. Although renal blood flow adequacy can be indirectly assessed by monitoring urine output after reperfusion, this method does not allow for objective evaluation of renal tissue oxygenation. We hypothesize that intraoperative monitoring of renal tissue oxygenation using NIRS may provide valuable real-time information and contribute to the early identification of postoperative acute kidney injury.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 7 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group1 | – | –A total of 41 adult patients (≥18 years) scheduled for elective orthotopic liver transplantation (OLT) and classified as American Society of Anesthesiologists (ASA) physical status III-IV were enrolled to study between 2024 and 2025 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing elective liver transplantation between the ages of 18 and 65
Key inclusion criteria (2 listed)
- Patients aged 18-65 scheduled for elective liver transplantation.
- American Society of Anesthesiologists (ASA) physical status III-IV were enrolled.
Key exclusion criteria (3 listed)
- Patients undergoing emergency liver transplantation,
- Advanced preexisting renal dysfunction
- İndividuals with significant cardiovascular instability
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Renal O3
Time frame: Measurements were recorded at three predefined surgical phases: • T0: Pre-anhepatic phase (beginning of dissection) • T1: Anhepatic phase (after clamping of the inferior vena cava and portal vein) • T2: Neohepatic phase (after graft reperfusion and compl
Renal parenchymal oxygen saturation was measured using a Masimo™ NIRS probe enclosed in a sterile sheath. During surgical dissection, the probe was positioned vertically on the Gerota's fascia overlying the kidney.
Cr
Time frame: Renal function was evaluated using serum creatinine levels measured preoperatively, at postoperative 24 hours, and at postoperative week 1.
Renal function was evaluated using serum creatinine levels
4 secondary outcomes
HR
Time frame: During surgery: • T0: Pre-anhepatic phase (beginning of dissection) • T1: Anhepatic phase (after clamping of the inferior vena cava and portal vein) • T2: Neohepatic phase (after graft reperfusion and completion of vascular anastomoses)
MAP
Time frame: During surgery: • T0: Pre-anhepatic phase (beginning of dissection) • T1: Anhepatic phase (after clamping of the inferior vena cava and portal vein) • T2: Neohepatic phase (after graft reperfusion and completion of vascular anastomoses)
CI
Time frame: During surgery: • T0: Pre-anhepatic phase (beginning of dissection) • T1: Anhepatic phase (after clamping of the inferior vena cava and portal vein) • T2: Neohepatic phase (after graft reperfusion and completion of vascular anastomoses)
SVV
Time frame: During surgery: • T0: Pre-anhepatic phase (beginning of dissection) • T1: Anhepatic phase (after clamping of the inferior vena cava and portal vein) • T2: Neohepatic phase (after graft reperfusion and completion of vascular anastomoses)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2026.
- Results publication: PubMed 25735719Bevan PJ. Should Cerebral Near-infrared Spectroscopy be Standard of Care in Adult Cardiac Surgery? Heart Lung Circ. 2015 Jun;24(6):544-50. doi: 10.1016/j.hlc.2015.01.011. Epub 2015 Feb 7.
- Results publication: PubMed 23439275Fischer GW, Silvay G. Cerebral oximetry in cardiac and major vascular surgery. HSR Proc Intensive Care Cardiovasc Anesth. 2010;2(4):249-56.
- Results publication: PubMed 16750751Edmonds HL Jr. Pro: all cardiac surgical patients should have intraoperative cerebral oxygenation monitoring. J Cardiothorac Vasc Anesth. 2006 Jun;20(3):445-9. doi: 10.1053/j.jvca.2006.03.003. No abstract available.
- Individual participant dataSharing planned: Yes. Demographic data including age, sex, and body mass index (BMI), as well as comorbidities, duration of surgery, and length of intensive care unit (ICU) stay, HR, MAP, Renal O3, creatin values
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Transplant, Complications and Renal Failure Acute Chronic, run by Inonu University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Renal O3 (time frame: Measurements were recorded at three predefined surgical phases: • T0: Pre-anhepatic phase (beginning of dissection) • T1: Anhepatic phase (after clamping of the inferior vena cava and portal vein) • T2: Neohepatic phase (after graft reperfusion and compl). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07409532, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2026.