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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03877133
Other study ID # 1901-087-100
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 11, 2019
Est. completion date February 28, 2021

Study information

Verified date October 2021
Source Seoul National University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date February 28, 2021
Est. primary completion date February 28, 2021
Accepts healthy volunteers No
Gender All
Age group 20 Years and older
Eligibility 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

Study Design


Intervention

Device:
Near-infrared spectroscopy
Regional oxygen saturation probe is applied to the skin near the kidney bilaterally and is connected to the regional oxygen saturation monitor.

Locations

Country Name City State
Korea, Republic of Seoul National University Hospital Seoul

Sponsors (1)

Lead Sponsor Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary Acute Kidney Injury Acute kidney injury defined by the Kidney Disease Improving Global Outcomes (KDIGO) criteria using postoperative serum creatinine Within 7 days after surgery
Secondary Length of hospital stay Length of hospital stay Within 30 days after surgery
Secondary Nadir oxygen delivery during the surgery Nadir oxygen delivery calculated by the cardiac output and arterial oxygen content Within average 8 hours after anesthesia induction during the transplantation surgery
Secondary Area under the curve of oxygen delivery during the surgery Area under the curve of oxygen delivery calculated by the cardiac output and arterial oxygen content Within average 8 hours after anesthesia induction during the transplantation surgery
Secondary Early allograft dysfunction Early 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. on the postoperative 7th day after liver transplantation
Secondary In-hospital mortality In-hospital mortality Within 30 days after surgery
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