Intraoperative Renal Desaturation and Postoperative Acute Kidney Injury

NCT04967105 | Completed

• 1 other identifier: PLAGH-AOC-003
• Study Type: observational
• Target: 157
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Acute Kidney Injury

Keywords

liver resection; elderly; renal oxygen saturation; near-infrared spectroscopy

Outcome Measures

Primary Outcomes (1)

• Postoperative acute kidney injury

  Postoperative acute kidney injury is defined according to the KDIGO criterion

  Postoperative 7 days

Secondary Outcomes (2)

• Death before and 30 days after discharge

  30 days after discharge

• Length of hospital stay

  Postoperative 30 days

Study Arms (1)

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

Interventions

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.

elderly patients following liver resection

Eligibility Criteria

• Age: 60 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chinese PLA General Hospital: lead
• Beijing Tsinghua Changgeng Hospital: collaborator

Study Sites (1)

Chinese PLA General Hospital

Beijing, Beijing Municipality, 100853, China

Location

MeSH Terms

Interventions

Spectroscopy, Near-Infrared

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Weidong Mi, PhD

  Chinese PLA General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director (Cheif expert of National key research and development program of China 2018YFC2001900)

Study Record Dates

• First Submitted: July 12, 2021
• First Posted: July 19, 2021
• Study Start: September 20, 2020
• Primary Completion: October 30, 2021
• Study Completion: January 30, 2022
• Last Updated: March 11, 2022

Record last verified: 2022-03

Locations

CN (1)