Association of Intraoperative Renal Regional Oxygen Saturation and Acute Kidney Injury

• Sponsor: Seoul National University Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT03877133
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Arm: 1
• Actual Duration (Months): 23.7
• Patients Per Site Per Month: 2.1

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Liver Transplant; Complications; Renal Injury	Device: Near-infrared spectroscopy	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 50 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: A prospective, single group, observational studyA prospective, single group, observational study
• Masking: None (Open Label)
• Masking Description: Does not need masking
• Primary Purpose: Prevention
• Official Title: Association of Intraoperative Renal Regional Oxygen Saturation and Acute Kidney Injury After Living Donor Liver Transplantation
• Actual Study Start Date: Mar 11, 2019
• Actual Primary Completion Date: Feb 28, 2021
• Actual Study Completion Date: Feb 28, 2021

Arms and Interventions

Arm	Intervention/Treatment
Other: Regional oxygen saturation group Near-infrared spectroscopy application to the skin near the kidney	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.

Outcome Measures

Primary Outcome Measures

1. Acute Kidney Injury [Within 7 days after surgery]

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

Secondary Outcome Measures

1. Length of hospital stay [Within 30 days after surgery]

   Length of hospital stay

2. Nadir oxygen delivery during the surgery [Within average 8 hours after anesthesia induction during the transplantation surgery]

   Nadir oxygen delivery calculated by the cardiac output and arterial oxygen content

3. Area under the curve of oxygen delivery during the surgery [Within average 8 hours after anesthesia induction during the transplantation surgery]

   Area under the curve of oxygen delivery calculated by the cardiac output and arterial oxygen content

4. Early allograft dysfunction [on the postoperative 7th day after liver transplantation]

   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.

5. In-hospital mortality [Within 30 days after surgery]

   In-hospital mortality

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Seoul National University Hospital	Seoul		Korea, Republic of	03080

Sponsors and Collaborators

• Seoul National University Hospital

Investigators

• Principal Investigator: Won Ho Kim, Kim, Seoul National University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Won Ho Kim, MD, Associate Professor, Seoul National University Hospital
• ClinicalTrials.gov Identifier: NCT03877133
• Other Study ID Numbers: 1901-087-100
• First Posted: Mar 15, 2019
• Last Update Posted: Oct 21, 2021
• Last Verified: Oct 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Won Ho Kim, MD, Associate Professor, Seoul National University Hospital: Near-infrared spectroscopy; Renal regional oxygen saturation; Living donor liver transplantation; Acute kidney injury
• Additional relevant MeSH terms: Acute Kidney Injury; Wounds and Injuries

Study Results

No Results Posted as of Oct 21, 2021