Intraoperative Renal Desaturation and Postoperative Acute Kidney Injury

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

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.

Study Overview

• Status: Completed
• Conditions: Postoperative Acute Kidney Injury
• Intervention / Treatment: Device: Near-infrared spectroscopy

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.

• Study Type: Observational
• Enrollment (Actual): 157

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100853
      • Chinese PLA General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients older than 60 years who intend to receive elective hepatectomy surgeries

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
elderly patients following liver resection; elderly patients (aged ≥60 years) scheduled for any type of liver resection due to benign or malignant hepatobiliary diseases	Device: Near-infrared spectroscopy; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative acute kidney injury	Postoperative acute kidney injury is defined according to the KDIGO criterion	Postoperative 7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Death before and 30 days after discharge	Collection of clinical data in the medical record and follow-up update through telephone	30 days after discharge
Length of hospital stay	Collection of clinical data in the medical record	Postoperative 30 days

Collaborators and Investigators

• Sponsor: Chinese PLA General Hospital
• Collaborators: Beijing Tsinghua Changgeng Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 20, 2020
• Primary Completion (Actual): October 30, 2021
• Study Completion (Actual): January 30, 2022

Study Registration Dates

• First Submitted: July 12, 2021
• First Submitted That Met QC Criteria: July 14, 2021
• First Posted (Actual): July 19, 2021

Study Record Updates

• Last Update Posted (Actual): March 11, 2022
• Last Update Submitted That Met QC Criteria: March 9, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: elderly; near-infrared spectroscopy; liver resection; renal oxygen saturation
• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency; Wounds and Injuries; Acute Kidney Injury
• Other Study ID Numbers: PLAGH-AOC-003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No