Skip to content

Association of Intraoperative Renal Regional Oxygen Saturation and Acute Kidney Injury

Association of Intraoperative Renal Regional Oxygen Saturation and Acute Kidney Injury After Living Donor Liver Transplantation

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03877133
Enrollment
50
Registered
2019-03-15
Start date
2019-03-11
Completion date
2021-02-28
Last updated
2021-10-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Liver Transplant; Complications, Renal Injury

Keywords

Near-infrared spectroscopy, Renal regional oxygen saturation, Living donor liver transplantation, Acute kidney injury

Brief summary

This study is a prospective observational study of a single cohort of the patients who will undergo a scheduled living donor liver transplantation. The investigators attempt to evaluate the association of intraoperative renal regional oxygen saturation and acute kidney injury in patients undergoing living donor liver transplantation. Near-infrared spectroscopy sensor will be attached to the skin near bilateral kidney areas in all patients and renal regional oxygen saturation will be monitored during the operation. Renal regional oxygen saturation (rSO2) of the patients who developed acute kidney injury postoperatively will be compared with rSO2 of the patients who did not.

Detailed description

Acute kidney injury is a frequent complication after liver transplantation, which is related to poor prognosis and longer hospital stay. There is no sensitive or specific marker for predicting postoperative acute kidney injury, although studies of the biomarkers have shown promising results. Near-infrared spectroscopy is a non-invasive and real-time monitoring device for regional oxygen saturation measurement. Previous studies revealed that it could be applied to the skin near the kidney and be used to monitor renal regional oxygen saturation. Therefore, in this study, the investigators will apply near-infrared spectroscopy around kidney area to measure real-time renal regional oxygen saturation during liver transplantation surgery and investigate the association between the intraoperative renal regional oxygen saturation and the development of post-transplant acute kidney injury.

Interventions

DEVICENear-infrared spectroscopy

Regional oxygen saturation probe is applied to the skin near the kidney bilaterally and is connected to the regional oxygen saturation monitor.

Sponsors

Seoul National University Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Masking description

Does not need masking

Intervention model description

A prospective, single group, observational study

Eligibility

Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Adult patients scheduled to undergo elective living donor liver transplantation * Patients who provided written informed consent

Exclusion criteria

* Missing preoperative serum creatinine value * Underlying kidney disease, such as hepatorenal syndrome, chronic kidney disease * History of unilateral or bilateral nephrectomy * Patients who died within 48 hours immediately after surgery * Any skin problem at the attachment site of regional oxygen saturation probe

Design outcomes

Primary

MeasureTime frameDescription
Acute Kidney InjuryWithin 7 days after surgeryAcute kidney injury defined by the Kidney Disease Improving Global Outcomes (KDIGO) criteria using postoperative serum creatinine

Secondary

MeasureTime frameDescription
Length of hospital stayWithin 30 days after surgeryLength of hospital stay
Nadir oxygen delivery during the surgeryWithin average 8 hours after anesthesia induction during the transplantation surgeryNadir oxygen delivery calculated by the cardiac output and arterial oxygen content
Area under the curve of oxygen delivery during the surgeryWithin average 8 hours after anesthesia induction during the transplantation surgeryArea under the curve of oxygen delivery calculated by the cardiac output and arterial oxygen content
Early allograft dysfunctionon the postoperative 7th day after liver transplantationEarly allograft dysfunction diagnosed by one or more of the following variables: (1) bilirubin \> 10 mg/dL on postoperative day 7; (2) prothrombin time: international normalized ratio \> 1.6 on postoperative day 7; (3) aminotransferase level (alanine aminotransferase or aspartate aminotransferase \> 2000 IU/ml within the first 7 postoperative days.
In-hospital mortalityWithin 30 days after surgeryIn-hospital mortality

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026