Clinical trial NCT04967105: Intraoperative Renal Desaturation and Postoperative Acute Kidney Injury
Official title: Intraoperative Renal Desaturation and Postoperative Acute Kidney Injury in Elderly Patients Undergoing Liver Resection: a Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Postoperative Acute Kidney Injury
Keywords: liver resection
elderly
renal oxygen saturation
near-infrared spectroscopy
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
Collaborators: name: Beijing Tsinghua Changgeng Hospital
First posted: 2021-07-19
Enrollment: 157
Sex: ALL
Minimum age (years): 60
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients older than 60 years who intend to receive elective hepatectomy surgeries

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Postoperative acute kidney injury
timeFrame: Postoperative 7 days
Secondary outcomes:
measure: Death before and 30 days after discharge
timeFrame: 30 days after discharge
measure: Length of hospital stay
timeFrame: Postoperative 30 days
Other outcomes:
Locations:
city: Beijing
country: China
facility: Chinese PLA General Hospital
state: Beijing
Study officials:
affiliation: Chinese PLA General Hospital
name: Weidong Mi, PhD
role: PRINCIPAL_INVESTIGATOR
References: