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
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|
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 :||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|
|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|
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.
- 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
- 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
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
|Contact: Won Ho Kim, MD, PhD||82-2-2072-2460 ext firstname.lastname@example.org|
|Contact: Hye-won Oh, MD, PhD||82-10-9151-4078 ext email@example.com|
|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 firstname.lastname@example.org|
|Contact: Hye-won Oh, MD, PhD 82-10-9151-4078 ext 2469 email@example.com|
|Principal Investigator:||Won Ho Kim, Kim||Seoul National University Hospital|