Clinical trial NCT03877133: Association of Intraoperative Renal Regional Oxygen Saturation and Acute Kidney Injury
Official title: Association of Intraoperative Renal Regional Oxygen Saturation and Acute Kidney Injury After Living Donor Liver Transplantation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Liver Transplant; Complications
Renal Injury
Keywords: Near-infrared spectroscopy
Renal regional oxygen saturation
Living donor liver transplantation
Acute kidney injury
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2019-03-15
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: A prospective, single group, observational study
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Acute Kidney Injury
timeFrame: Within 7 days after surgery
Secondary outcomes:
measure: Length of hospital stay
timeFrame: Within 30 days after surgery
measure: Nadir oxygen delivery during the surgery
timeFrame: Within average 8 hours after anesthesia induction during the transplantation surgery
measure: Area under the curve of oxygen delivery during the surgery
timeFrame: Within average 8 hours after anesthesia induction during the transplantation surgery
measure: Early allograft dysfunction
timeFrame: on the postoperative 7th day after liver transplantation
measure: In-hospital mortality
timeFrame: Within 30 days after surgery
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Won Ho Kim, Kim
role: PRINCIPAL_INVESTIGATOR
References: