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NCT Number: NCT03877133

Association of Intraoperative Renal Regional Oxygen Saturation and Acute Kidney Injury

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.

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Key information

Conditions

Liver Transplant; Complications Acute Kidney Injury Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Renal Injury Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Hospital

Seoul, 03080, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Near-infrared spectroscopy

Device

Regional oxygen saturation probe is applied to the skin near the kidney bilaterally and is connected to the regional oxygen saturation monitor.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Mar 15, 2019
Registry last updated
Oct 21, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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