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Completed

NCT Number: NCT04967105

Intraoperative Renal Desaturation and Postoperative Acute Kidney Injury

The aim of this study is to investigate the changes in renal regional oxygen saturation (rSO2) monitored by near-infrared spectroscopy (NIRS) and its relationship with the occurrence of postoperative AKI.

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Key information

Age range

60 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Chinese PLA General Hospital

Beijing, Beijing Municipality, 100853, China

About this study

Postoperative acute kidney injury (AKI) is a severe complication after liver resection and contributes to increased morbidity and mortality.

Advanced age reduces renal autoregulatory capacity due to physiological and functional changes, thus render the elderly to suffer postoperative AKI and probably the consequent chronic kidney disease. Thus, it is essential to identify those patients at high risk to develop postoperative AKI to optimize perioperative prevention and protection strategies.

Despite the multiple risk factors and potential mechanisms that have been identified, the diagnosis of postoperative AKI depending on serum creatinine changes have been delayed for early identification of postoperative AKI. It is of great interest to develop target strategies for close motoring of renal function.

This study is a prospective cohort study to investigate the associations between intraoperative renal desaturation measured by NIRS and postoperative AKI. The investigators intend to access the optimal threshold values of renal rSO2 for predicting postoperative AKI. Desaturation of renal rSO2 will be defined by the severity and duration of NIRS values during the surgical process. The principal clinical outcome of the study is postoperative AKI, defined as an absolute increase in serum creatinine of 0.3 mg/dL within 48 hours or a 1.5-fold increase from preoperative baseline within seven days after surgery, according to the Kidney Disease: Improving Global Outcomes (KDIGO) criterion.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Elderly patients (defined as 60 years of age or older) scheduled for elective liver resection

Exclusion criteria

  • Emergency surgery
  • Liver transplantation
  • Preoperative hemodialysis
  • BMI > 30
  • Renal depth (distance from the capsule of the kidney to the skin surface) > 4 cm
  • Unable or failed to sign the informed consent

Treatment and study plan

Near-infrared spectroscopy

Device

Before the induction of anesthesia, NIRS sensors were placed on both sides of the flank area that overlies the kidney to monitor renal SO2, whose alteration trends over time during operation will be recorded and evaluated in later analysis.

Primary outcomes

  1. Postoperative acute kidney injury

    Time frame: Postoperative 7 days

    Postoperative acute kidney injury is defined according to the KDIGO criterion

Secondary outcomes

  1. Death before and 30 days after discharge

    Time frame: 30 days after discharge

    Collection of clinical data in the medical record and follow-up update through telephone

  2. Length of hospital stay

    Time frame: Postoperative 30 days

    Collection of clinical data in the medical record

Sponsors and collaborators

Lead sponsor

Chinese PLA General Hospital

Other

Collaborators

  • Beijing Tsinghua Changgeng Hospital

Registry information

Official study title

Intraoperative Renal Desaturation and Postoperative Acute Kidney Injury in Elderly Patients Undergoing Liver Resection: a Prospective Cohort Study

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Jul 19, 2021
Registry last updated
Mar 11, 2022

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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