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Association of Intraoperative Renal Regional Oxygen Saturation and Acute Kidney Injury

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ClinicalTrials.gov Identifier: NCT03877133
Recruitment Status : Recruiting
First Posted : March 15, 2019
Last Update Posted : May 14, 2019
Sponsor:
Information provided by (Responsible Party):
Won Ho Kim, MD, Seoul National University Hospital

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 Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Intervention Model Description: A 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 : March 11, 2019
Estimated Primary Completion Date : February 28, 2020
Estimated Study Completion Date : February 28, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. Acute Kidney Injury [ Time Frame: 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 [ Time Frame: Within 30 days after surgery ]
    Length of hospital stay

  2. Nadir oxygen delivery during the surgery [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Within 30 days after surgery ]
    In-hospital mortality



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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03877133


Contacts
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Contact: Won Ho Kim, MD, PhD 82-2-2072-2460 ext 2462 wonhokim.ane@gmail.com
Contact: Hye-won Oh, MD, PhD 82-10-9151-4078 ext 2469 suihimeoh@gmail.com

Locations
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Korea, Republic of
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of, 03080
Contact: Won Ho Kim, MD,PhD    82-2-2072-2460 ext 2462    wonhokim.ane@gmail.com   
Contact: Hye-won Oh, MD, PhD    82-10-9151-4078 ext 2469    suihimeoh@gmail.com   
Sponsors and Collaborators
Seoul National University Hospital
Investigators
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Principal Investigator: Won Ho Kim, Kim Seoul National University Hospital

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Responsible Party: Won Ho Kim, MD, Associate Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT03877133     History of Changes
Other Study ID Numbers: 1901-087-100
First Posted: March 15, 2019    Key Record Dates
Last Update Posted: May 14, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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, Seoul National University Hospital:
Near-infrared spectroscopy
Renal regional oxygen saturation
Living donor liver transplantation
Acute kidney injury
Additional relevant MeSH terms:
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Acute Kidney Injury
Wounds and Injuries
Renal Insufficiency
Kidney Diseases
Urologic Diseases