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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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04967105
Enrollment
157
Registered
2021-07-19
Start date
2020-09-20
Completion date
2022-01-30
Last updated
2022-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Acute Kidney Injury

Keywords

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

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.

Interventions

DEVICENear-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.

Sponsors

Beijing Tsinghua Changgeng Hospital
CollaboratorOTHER
Chinese PLA General Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
60 Years to 100 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Postoperative acute kidney injuryPostoperative 7 daysPostoperative acute kidney injury is defined according to the KDIGO criterion

Secondary

MeasureTime frameDescription
Death before and 30 days after discharge30 days after dischargeCollection of clinical data in the medical record and follow-up update through telephone
Length of hospital stayPostoperative 30 daysCollection of clinical data in the medical record

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026