Clinical trial NCT04922866: Predictive Nomogram for Postoperative Acute Kidney Injury (AKI) in Elderly Patients Following Liver Resection
Official title: Predictive Nomogram for Postoperative Acute Kidney Injury (AKI) in Elderly Patients Following Liver Resection
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Postoperative Acute Kidney Injury
Keywords: acute kidney injury
predictive nomogram
elderly
liver resection
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
First posted: 2021-06-11
Enrollment: 843
Sex: ALL
Minimum age (years): 65
Maximum age (years): 100
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Elderly patients (aged ≥ 65 years) with benign and malignant liver diseases of the Chinese PLA General Hospital HPB (Hepato-Pancreato-Biliary) Center undergoing liver resection from 2012-2019

Brief summary: Acute kidney injury (AKI) is a severe complication after liver resection and is associated with morbidity and mortality. The incidence of postoperative AKI is significantly higher in elderly patients, especially in those with comorbidities.

There is currently limited evidence on the incidence and associations of postoperative AKI in elderly patients following liver resection.

This study will evaluate the incidence and associations of AKI in elderly patients after liver resection and its impact on postoperative mortality.

Detailed description: The occurrence of postoperative AKI is independently associated with 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.

Although elderly patients account for approximately 25% of surgical procedures, the incidence and associations of AKI in this group of patients are rarely understood.

Thus, it is essential to identify those patients at high risk to develop postoperative AKI to optimize perioperative prevention and protection strategies.

This study is a retrospective cohort study, aim to access risk factors of postoperative AKI and its association with outcomes. The investigators will develop and validate a predictive model for postoperative AKI.

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.

Eligibility criteria: Inclusion Criteria:

* Elderly patients aged ≥65 years
* Benign and malignant liver diseases

Exclusion Criteria:

* Emergency operation
* Liver transplantation

Primary outcomes:
measure: Postoperative acute kidney injury
timeFrame: postoperative seven days
Secondary outcomes:
measure: Incidence of postoperative AKI
timeFrame: postoperative seven days
Other outcomes:
Locations:
city: Beijing
country: China
facility: Chinese PLA General Hospital
state: Beijing
city: Beijing
country: China
facility: Chinese PLA General Hospital
Study officials:
affiliation: Chinese PLA General Hospital
name: Weidong Mi, PhD
role: STUDY_DIRECTOR
References:
citation: Yu Y, Zhang C, Zhang F, Liu C, Li H, Lou J, Xu Z, Liu Y, Cao J, Mi W. Development and validation of a risk nomogram for postoperative acute kidney injury in older patients undergoing liver resection: a pilot study. BMC Anesthesiol. 2022 Jan 13;22(1):22. doi: 10.1186/s12871-022-01566-z.