Intraoperative Renal Desaturation and Postoperative Acute Kidney Injury

Completed

• Conditions: Postoperative Acute Kidney Injury
• Interventions: Device: Near-infrared spectroscopy

• Registration Number: NCT04967105
• Lead Sponsor: Chinese PLA General Hospital

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.

Study Timeline

• Study Start: 2020-09-20
• Study First Submitted: 2021-07-12
• Study First Submitted QC: 2021-07-14
• Study First Posted: 2021-07-19
• Primary Completion: 2021-10-30
• Study Completion: 2022-01-30
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-09
• Last Update Posted: 2022-03-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 157

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
elderly patients following liver resection	Near-infrared spectroscopy	elderly patients (aged ≥60 years) scheduled for any type of liver resection due to benign or malignant hepatobiliary diseases

Primary Outcome Measures

Name	Time	Method
Postoperative acute kidney injury	Postoperative 7 days	Postoperative acute kidney injury is defined according to the KDIGO criterion

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Chinese PLA General Hospital; 🇨🇳 Beijing, Beijing, China