Intraoperative Renal Desaturation and Postoperative Acute Kidney Injury

Postoperative Acute Kidney Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04967105
• Other study ID #: PLAGH-AOC-003
• Status: Completed
• Start date: September 20, 2020
• Est. completion date: January 30, 2022

Study information

• Verified date: March 2022
• Source: Chinese PLA General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 157
• Est. completion date: January 30, 2022
• Est. primary completion date: October 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Kidney Injury
• Postoperative Acute Kidney Injury
• Wounds and Injuries

Intervention

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.

Locations

Country	Name	City	State
China	Chinese PLA General Hospital	Beijing	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Chinese PLA General Hospital	Beijing Tsinghua Changgeng Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative acute kidney injury	Postoperative acute kidney injury is defined according to the KDIGO criterion	Postoperative 7 days
Secondary	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
Secondary	Length of hospital stay	Collection of clinical data in the medical record	Postoperative 30 days