Etiology, Epidemiology and Prognostics of AKI

November 26, 2023 updated by: Ding Feng, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

The Study of Etiology, Epidemiology and Prognostic Factors of Acute Kidney Injury

  • To investigate the etiology and epidemiology of acute kidney injury (AKI).
  • To find out risk factors associated with the occurence of AKI.
  • To find out risk factors related to the prognosis of AKI,focusing on uremic toxins, inflammation, oxidative stress and nutritional status.
  • To study on the relationship between gene polymorphism and prognosis of acute kidney injury.

Study Overview

Status

Recruiting

Conditions

Detailed Description

  1. To investigate the relationship between preexisting protein-energy wasting (PEW) and adverse outcomes in patients with AKI.
  2. To evaluate the association of serum nutritional variables and prognosis of AKI.
  3. Given the different half-lives of serum nutritional markers, we hypothesized that the utility of serum nutritional variables as prognostic predictors may differ in early death (<7 days) and late death (>7 days, <28 days) patients.
  4. To investigate the various kinds of uremic toxins in AKI, furthermore, to evaluate the relationship between uremic toxins, especially protein bound toxins, and short- or long-term mortality in AKI patients.
  5. To investigate the mineral bone disorders in AKI,and to evaluate whether these markers would role as prognostic predictors of AKI.
  6. Several risk factors of mortality in AKI,such as markers of PEW, inflammation and serum creatinine,have been used; however, no single indicator is considered to be a "gold standard."

Study Type

Observational

Enrollment (Estimated)

713

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 Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200011
        • Recruiting
        • Shanghai Ninth People's Hospital
        • Contact:
        • Principal Investigator:
          • Wenji Wang, MD

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

18 years to 89 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

adult patients aged >18 years, with hospital-acquired acute kidney injury, from a university-affiliated hospital in Shanghai, China.

Description

Inclusion Criteria:

  • age >=18 years and <= 88 years
  • clinically diagnosed with acute kidney injury, according KDIGO criteria.

Exclusion Criteria:

  • preexisting chronic kidney failure (defined as an eGFR <60 ml/min per 1.73 m2)
  • post-renal obstruction or rapid progressive glomerulonephritis as the main cause of AKI
  • known acute renal dysfunction
  • hospital stays <24 hours
  • malignancy

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: Prospective

Cohorts and Interventions

Group / Cohort
Hospital-acquired AKI
Adult patients with Hospital-acquired AKI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
all-cause mortality
Time Frame: 90 days
90 days

Secondary Outcome Measures

Outcome Measure
Time Frame
renal function survival rate
Time Frame: 90 days
90 days
days in hospital
Time Frame: 90 days
90 days

Collaborators and Investigators

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

Sponsor

Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Investigators

  • Study Director: Feng Ding, PhD, Division of Nephrology, Shanghai Ninth People's Hospital, School of Medicine, Shanghai Jiaotong University

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

January 1, 2015

Primary Completion (Estimated)

June 1, 2024

Study Completion (Estimated)

June 1, 2024

Study Registration Dates

First Submitted

November 16, 2016

First Submitted That Met QC Criteria

November 16, 2016

First Posted (Estimated)

November 18, 2016

Study Record Updates

Last Update Posted (Actual)

November 28, 2023

Last Update Submitted That Met QC Criteria

November 26, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AKI-2016-01

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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