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Association of Intraoperative Renal Regional Oxygen Saturation and Acute Kidney Injury

Primary Purpose

Liver Transplant; Complications, Renal Injury

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Near-infrared spectroscopy
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Liver Transplant; Complications focused on measuring Near-infrared spectroscopy, Renal regional oxygen saturation, Living donor liver transplantation, Acute kidney injury

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Seoul National University Hospital

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Regional oxygen saturation group

Arm Description

Near-infrared spectroscopy application to the skin near the kidney

Outcomes

Primary Outcome Measures

Acute Kidney Injury
Acute kidney injury defined by the Kidney Disease Improving Global Outcomes (KDIGO) criteria using postoperative serum creatinine

Secondary Outcome Measures

Length of hospital stay
Length of hospital stay
Nadir oxygen delivery during the surgery
Nadir oxygen delivery calculated by the cardiac output and arterial oxygen content
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
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.
In-hospital mortality
In-hospital mortality

Full Information

First Posted
March 8, 2019
Last Updated
October 20, 2021
Sponsor
Seoul National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03877133
Brief Title
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

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
March 11, 2019 (Actual)
Primary Completion Date
February 28, 2021 (Actual)
Study Completion Date
February 28, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Transplant; Complications, Renal Injury
Keywords
Near-infrared spectroscopy, Renal regional oxygen saturation, Living donor liver transplantation, Acute kidney injury

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
A prospective, single group, observational study
Masking
None (Open Label)
Masking Description
Does not need masking
Allocation
N/A
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Regional oxygen saturation group
Arm Type
Other
Arm Description
Near-infrared spectroscopy application to the skin near the kidney
Intervention Type
Device
Intervention Name(s)
Near-infrared spectroscopy
Intervention Description
Regional oxygen saturation probe is applied to the skin near the kidney bilaterally and is connected to the regional oxygen saturation monitor.
Primary Outcome Measure Information:
Title
Acute Kidney Injury
Description
Acute kidney injury defined by the Kidney Disease Improving Global Outcomes (KDIGO) criteria using postoperative serum creatinine
Time Frame
Within 7 days after surgery
Secondary Outcome Measure Information:
Title
Length of hospital stay
Description
Length of hospital stay
Time Frame
Within 30 days after surgery
Title
Nadir oxygen delivery during the surgery
Description
Nadir oxygen delivery calculated by the cardiac output and arterial oxygen content
Time Frame
Within average 8 hours after anesthesia induction during the transplantation surgery
Title
Area under the curve of oxygen delivery during the surgery
Description
Area under the curve of oxygen delivery calculated by the cardiac output and arterial oxygen content
Time Frame
Within average 8 hours after anesthesia induction during the transplantation surgery
Title
Early allograft dysfunction
Description
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.
Time Frame
on the postoperative 7th day after liver transplantation
Title
In-hospital mortality
Description
In-hospital mortality
Time Frame
Within 30 days after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Won Ho Kim, Kim
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No

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Association of Intraoperative Renal Regional Oxygen Saturation and Acute Kidney Injury

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