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Association of Intraoperative Renal Regional Oxygen Saturation and Acute Kidney Injury

NCT ID: NCT03877133

Last Updated: 2021-10-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-11

Study Completion Date

2021-02-28

Brief Summary

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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

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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.

Conditions

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Liver Transplant; Complications Renal Injury

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

A prospective, single group, observational study
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Does not need masking

Study Groups

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Regional oxygen saturation group

Near-infrared spectroscopy application to the skin near the kidney

Group Type OTHER

Near-infrared spectroscopy

Intervention Type DEVICE

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

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Won Ho Kim, MD

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Won Ho Kim, Kim

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Locations

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Seoul National University Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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1901-087-100

Identifier Type: -

Identifier Source: org_study_id