Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2025-12-26 @ 2:12 AM
Study NCT ID:
NCT04967105
Status:
COMPLETED
Last Update Posted:
2022-03-11
First Post:
2021-07-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Intraoperative Renal Desaturation and Postoperative Acute Kidney Injury
Sponsor:
Chinese PLA General Hospital
Organization:
Study Overview
Official Title:
Intraoperative Renal Desaturation and Postoperative Acute Kidney Injury in Elderly Patients Undergoing Liver Resection: a Prospective Cohort Study
Status:
COMPLETED
Status Verified Date:
2022-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: