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

March 9, 2022 updated by: Weidong Mi, Chinese PLA General Hospital

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

843

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China, 100089
        • Chinese PLA General Hospital
    • Beijing
      • Beijing, Beijing, China
        • Chinese PLA General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years to 100 years (OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Emergency operation
  • Liver transplantation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
elderly patients following hepatectomy
elderly patients (aged ≥65 years) scheduled for any type of liver resection
Other: no intervention
no intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative acute kidney injury
Time Frame: postoperative seven days
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of postoperative AKI
Time Frame: postoperative seven days
collection of clinical data in the medical record and follow-up update
postoperative seven days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese PLA General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 1, 2020

Primary Completion (ACTUAL)

January 30, 2022

Study Completion (ACTUAL)

January 30, 2022

Study Registration Dates

First Submitted

June 7, 2021

First Submitted That Met QC Criteria

June 10, 2021

First Posted (ACTUAL)

June 11, 2021

Study Record Updates

Last Update Posted (ACTUAL)

March 11, 2022

Last Update Submitted That Met QC Criteria

March 9, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PLAGH-AOC-002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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