NCT04922866

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
843

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2020

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2020

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

June 7, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 11, 2021

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2022

Completed
Last Updated

March 11, 2022

Status Verified

March 1, 2022

Enrollment Period

1.4 years

First QC Date

June 7, 2021

Last Update Submit

March 9, 2022

Conditions

Keywords

acute kidney injurypredictive nomogramelderlyliver resection

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Incidence of postoperative AKI

    postoperative seven days

Study Arms (1)

elderly patients following hepatectomy

elderly patients (aged ≥65 years) scheduled for any type of liver resection

Other: no intervention

Interventions

no intervention

elderly patients following hepatectomy

Eligibility Criteria

Age65 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-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

You may qualify if:

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

You may not qualify if:

  • Emergency operation
  • Liver transplantation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Chinese PLA General Hospital

Beijing, Beijing Municipality, China

Location

Chinese PLA General Hospital

Beijing, 100089, China

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Weidong Mi, PhD

    Chinese PLA General Hospital

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director (Cheif expert of National key research and development program of China 2018YFC2001900)

Study Record Dates

First Submitted

June 7, 2021

First Posted

June 11, 2021

Study Start

September 1, 2020

Primary Completion

January 30, 2022

Study Completion

January 30, 2022

Last Updated

March 11, 2022

Record last verified: 2022-03

Locations