Predictive Nomogram for Postoperative Acute Kidney Injury in Older Patients Undergoing Noncardiac Surgery

August 17, 2022 updated by: Weidong Mi, Chinese PLA General Hospital
Postoperative acute kidney injury is associated increased risk of morbidity and mortality. Older patients are at high risk of developing postoperative acute kidney injury. However, the incidence and associations of postoperative acute kidney injury in older patients are not well understood. This study aims to develop and validate a predictive nomogram for postoperative acute kidney injury in older patients undergoing noncardiac surgery.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Postoperative acute kidney injury (AKI) affects approximately 2% to 40% of patients undergoing cardiac and major noncardiac surgeries.

Older patients are more susceptible to renal impairment than younger patients. However, the incidence and associations of AKI in older patients are rarely understood.

Generally, in-depth knowledge of risk factors and thus able to identify patients at high risk to develop postoperative AKI is essential to optimize perioperative prevention and protection strategies.

In this retrospective study, the investigators intend to develop and validate a predictive model for postoperative using the identified risk factors.

The primary outcome is postoperative AKI, which according to the Kidney Disease: Improving Global Outcomes (KDIGO) criterion, 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 7 days after surgery.

Study Type

Observational

Enrollment (Anticipated)

50000

Contacts and Locations

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

Study Contact

Study Contact Backup

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China
        • Recruiting
        • The First Medical Center of Chinese PLA General Hospital
        • Contact:
        • Contact:

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

63 years to 118 years (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Older patients (aged ≥ 65 years) undergoing noncardiac surgery from 2012-2019

Description

Inclusion Criteria:

  • Patients aged 65 years and older

Exclusion Criteria:

  • Emergency operation
  • Cardiac surgery
  • Incomplete data
  • Incomplete data
  • Local anesthesia
  • Preoperative renal failure or requirement for dialysis

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

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
older patients undergoing noncardiac surgery
older patients (aged ≥65 years) scheduled for noncardiac surgery
Other: no intervention
no intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
acute kidney injury
Time Frame: 7 days after surgery
an absolute increase in serum creatinine of 0.3 mg/dl within 48 hours or a 1.5-fold increase from preoperative baseline within 7 days after surgery
7 days after surgery

Collaborators and Investigators

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

Sponsor

Chinese PLA General Hospital

Investigators

  • Principal Investigator: Weidong Mi, PhD, The First Medical Center of Chinese PLA General Hospital

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)

April 1, 2022

Primary Completion (Anticipated)

December 30, 2022

Study Completion (Anticipated)

December 30, 2022

Study Registration Dates

First Submitted

August 17, 2022

First Submitted That Met QC Criteria

August 17, 2022

First Posted (Actual)

August 18, 2022

Study Record Updates

Last Update Posted (Actual)

August 18, 2022

Last Update Submitted That Met QC Criteria

August 17, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PLAGH-AOC-004

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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