Predictive Nomogram for Postoperative Acute Kidney Injury (AKI) in Elderly Patients Following Liver Resection

Postoperative Acute Kidney Injury Clinical Trial

Official title:

Predictive Nomogram for Postoperative Acute Kidney Injury (AKI) in Elderly Patients Following Liver Resection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04922866
• Other study ID #: PLAGH-AOC-002
• Status: Completed
• Start date: September 1, 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

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 843
• Est. completion date: January 30, 2022
• Est. primary completion date: January 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years to 100 Years

Eligibility

Inclusion Criteria:

• Elderly patients aged =65 years

• Benign and malignant liver diseases

Exclusion Criteria:

• Emergency operation

• Liver transplantation

Related Conditions & MeSH terms

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

Intervention

Other:
• no intervention
no intervention

Locations

Country	Name	City	State
China	Chinese PLA General Hospital	Beijing	Beijing
China	Chinese PLA General Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Chinese PLA General 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 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.	postoperative seven days
Secondary	Incidence of postoperative AKI	collection of clinical data in the medical record and follow-up update	postoperative seven days