Association of Intraoperative Renal Regional Oxygen Saturation and Acute Kidney Injury

Liver Transplant; Complications Clinical Trial

Official title:

Association of Intraoperative Renal Regional Oxygen Saturation and Acute Kidney Injury After Living Donor Liver Transplantation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03877133
• Other study ID #: 1901-087-100
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Acute Kidney Injury
• Liver Transplant; Complications
• Renal Injury
• Wounds and Injuries

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