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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2009 by Huashan Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Huashan Hospital
ClinicalTrials.gov Identifier:
NCT00953992
First received: August 5, 2009
Last updated: June 9, 2010
Last verified: August 2009
  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

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 Huashan Hospital:

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

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: 300
Study Start Date: April 2009
Estimated Study Completion Date: August 2012
Estimated Primary Completion Date: December 2011 (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

Ages Eligible for Study:   16 Years to 88 Years
Genders Eligible for Study:   Both
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 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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00953992

Contacts
Contact: Feng Ding, professor 86-02152888135 ding_feng@hotmail.com

Locations
China
Huashan hospital Recruiting
Shanghai, China, 200040
Contact: Feng Ding, professor    86-02152888135    ding_feng@hotmail.com   
Sponsors and Collaborators
Huashan Hospital
Investigators
Principal Investigator: Feng Ding, professor Huashan Hospital
  More Information

No publications provided

Responsible Party: Feng Ding, Huashan hospital
ClinicalTrials.gov Identifier: NCT00953992     History of Changes
Other Study ID Numbers: KY2009-107
Study First Received: August 5, 2009
Last Updated: June 9, 2010
Health Authority: China: Ethics Committee

Keywords provided by Huashan Hospital:
acute kidney disease
prognosis
oxidative stress
inflammation
gene polymorphism

Additional relevant MeSH terms:
Acute Kidney Injury
Renal Insufficiency
Wounds and Injuries
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on July 20, 2014