Intraoperative Assessment of Renal Tissue Oxygenation Using NIRS

NCT07409532 | Completed

• 1 other identifier: Inonu Kidney03
• Study Type: observational
• Target: 41
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Renal Failure Acute Chronic; Liver Transplant, Complications

Keywords

NIRS; Liver Transplantation; Renal Function

Outcome Measures

Primary Outcomes (2)

• 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.

  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

  Renal function was evaluated using serum creatinine levels measured preoperatively, at postoperative 24 hours, and at postoperative week 1.

Secondary Outcomes (4)

• HR

  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

  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

  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

  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)

Study Arms (1)

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

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing elective liver transplantation between the ages of 18 and 65

You may qualify if:

• Patients aged 18-65 scheduled for elective liver transplantation.
• American Society of Anesthesiologists (ASA) physical status III-IV were enrolled.

You may not qualify if:

• Patients undergoing emergency liver transplantation,
• Advanced preexisting renal dysfunction
• İndividuals with significant cardiovascular instability

Sponsors & Collaborators

• Inonu University: lead

Study Sites (1)

Inonu University Liver Transplant Institute

Malatya, 44280, Turkey (Türkiye)

Location

Related Publications (3)

• 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.

  PMID: 25735719 RESULT

• Fischer GW, Silvay G. Cerebral oximetry in cardiac and major vascular surgery. HSR Proc Intensive Care Cardiovasc Anesth. 2010;2(4):249-56.

  PMID: 23439275 RESULT

• Edmonds 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.

  PMID: 16750751 RESULT

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 7 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 2, 2026
• First Posted: February 13, 2026
• Study Start: December 1, 2022
• Primary Completion: July 15, 2024
• Study Completion: August 7, 2025
• Last Updated: February 13, 2026

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share

Locations

TU (1)