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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

Tracking Information
First Submitted Date  ICMJE March 8, 2019
First Posted Date  ICMJE March 15, 2019
Last Update Posted Date May 14, 2019
Actual Study Start Date  ICMJE March 11, 2019
Estimated Primary Completion Date February 28, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 14, 2019)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03877133 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 14, 2019)
  • Length of hospital stay [ Time Frame: Within 30 days after surgery ]
    Length of hospital stay
  • 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
  • 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
  • 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.
  • In-hospital mortality [ Time Frame: Within 30 days after surgery ]
    In-hospital mortality
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Association of Intraoperative Renal Regional Oxygen Saturation and Acute Kidney Injury
Official Title  ICMJE Association of Intraoperative Renal Regional Oxygen Saturation and Acute Kidney Injury After Living Donor Liver Transplantation
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.

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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE
  • Liver Transplant; Complications
  • Renal Injury
Intervention  ICMJE 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.
Study Arms  ICMJE Regional oxygen saturation group
Near-infrared spectroscopy application to the skin near the kidney
Intervention: Device: Near-infrared spectroscopy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 14, 2019)
50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 28, 2020
Estimated Primary Completion Date February 28, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
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
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03877133
Other Study ID Numbers  ICMJE 1901-087-100
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Won Ho Kim, MD, Seoul National University Hospital
Study Sponsor  ICMJE Seoul National University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Won Ho Kim, Kim Seoul National University Hospital
PRS Account Seoul National University Hospital
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP