NCT03877133

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 8, 2019

Completed
3 days until next milestone

Study Start

First participant enrolled

March 11, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 15, 2019

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2021

Completed
Last Updated

October 21, 2021

Status Verified

October 1, 2021

Enrollment Period

2 years

First QC Date

March 8, 2019

Last Update Submit

October 20, 2021

Conditions

Liver Transplant; ComplicationsRenal Injury

Keywords

Near-infrared spectroscopyRenal regional oxygen saturationLiving donor liver transplantationAcute kidney injury

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Length of hospital stay

    Within 30 days after surgery

  • Nadir oxygen delivery during the surgery

    Within average 8 hours after anesthesia induction during the transplantation surgery

  • Area under the curve of oxygen delivery during the surgery

    Within average 8 hours after anesthesia induction during the transplantation surgery

  • Early allograft dysfunction

    on the postoperative 7th day after liver transplantation

  • In-hospital mortality

    Within 30 days after surgery

Study Arms (1)

Regional oxygen saturation group

OTHER

Near-infrared spectroscopy application to the skin near the kidney

Device: Near-infrared spectroscopy

Interventions

Near-infrared spectroscopyDEVICE

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

Regional oxygen saturation group

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, 03080, South Korea

Location

MeSH Terms

Conditions

Acute Kidney Injury

Interventions

Spectroscopy, Near-Infrared

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Diagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisSpectrum AnalysisChemistry Techniques, AnalyticalInvestigative Techniques

Study Officials

  • Won Ho Kim, Kim

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
Does not need masking
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: A prospective, single group, observational study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

March 8, 2019

First Posted

March 15, 2019

Study Start

March 11, 2019

Primary Completion

February 28, 2021

Study Completion

February 28, 2021

Last Updated

October 21, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)