We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Etiology, Epidemiology and Prognostics of Acute Kidney Injury (AKI)

This study is currently recruiting participants.
Verified August 2017 by Feng Ding,MD, Huashan Hospital
Sponsor:
ClinicalTrials.gov Identifier:
NCT00953992
First Posted: August 6, 2009
Last Update Posted: August 31, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Information provided by (Responsible Party):
Feng Ding,MD, Huashan Hospital
  Purpose
  • To investigate the etiology, epidemiology and prognostic factors of acute kidney injury.
  • To find out risk factors that relate with the prognosis of acute kidney injury,focusing on inflammation, oxidative stress and nutritional status.
  • To study on the relationship between gene polymorphism and prognosis of acute kidney injury.

Condition
Renal Failure Nutrition Disorders

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Study of Etiology, Epidemiology and Prognostic Factors of Acute Kidney Injury

Further study details as provided by Feng Ding,MD, Huashan Hospital:

Primary Outcome Measures:
  • renal function survival rate days in the hospital days in the ICU [ Time Frame: discharg from hospital, 28days,90days ]

Biospecimen Retention:   Samples Without DNA
1ml whole blood and 1ml serum will obtained within 24 hour after AKI for hematological and biochemistry analyze.

Estimated Enrollment: 600
Study Start Date: April 2009
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Detailed Description:
  1. to investigate the relationship between preexisting malnutrition and adverse outcomes in patients with AKI

    - Several nutritional assessment methods such as anthropometric, clinical and biochemical evaluations have been used; however, no single indicator is considered to be a "gold standard."

  2. to evaluate the association of serum nutritional variables and prognosis of acute kidney injury
  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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   16 Years to 88 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients selected from a university-affiliated hospital in Shanghai, China.
Criteria

Inclusion Criteria:

  • age >=16 years and <= 88 years
  • clinically diagnosed with acute kidney injury, according RIFLE or KDIGO criteria.

Exclusion Criteria:

  • acute Renal Failure occurring in the setting of burns, obstructive uropathy, allergic interstitial nephritis, acute or rapidly progressive glomerulonephritis, vasculitis, hemolytic-uremic syndrome, thrombotic thrombocytopenic purpura (TTP), malignant hypertension, scleroderma renal crisis, atheroembolism, functional or surgical nephrectomy, hepatorenal syndrome, cyclosporin or tacrolimus nephrotoxicity
  • Do Not Resuscitate (DNR) status
  • subjects enrolled in another clinical trial that could affect the outcome of this study protocol
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00953992


Contacts
Contact: Feng Ding, professor 86-02152888135 dingfeng@sjtu.edu.cn

Locations
China
Shanghai Ninth People's Hospital Recruiting
Shanghai, China, 200011
Contact: Feng Ding, professor    86-02152888135    dingfeng@sjtu.edu.cn   
Sponsors and Collaborators
Huashan Hospital
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Investigators
Principal Investigator: Feng Ding, professor Huashan Hospital
  More Information

Responsible Party: Feng Ding,MD, professor, Huashan Hospital
ClinicalTrials.gov Identifier: NCT00953992     History of Changes
Other Study ID Numbers: KY2009-107
First Submitted: August 5, 2009
First Posted: August 6, 2009
Last Update Posted: August 31, 2017
Last Verified: August 2017

Keywords provided by Feng Ding,MD, Huashan Hospital:
acute kidney disease
prognosis
oxidative stress
inflammation
gene polymorphism

Additional relevant MeSH terms:
Renal Insufficiency
Acute Kidney Injury
Nutrition Disorders
Kidney Diseases
Urologic Diseases