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

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00953992
Recruitment Status : Completed
First Posted : August 6, 2009
Last Update Posted : August 22, 2019
Sponsor:
Collaborator:
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Information provided by (Responsible Party):
Feng Ding,MD, Huashan Hospital

Tracking Information
First Submitted Date August 5, 2009
First Posted Date August 6, 2009
Last Update Posted Date August 22, 2019
Study Start Date April 2009
Actual Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 5, 2009)
renal function survival rate days in the hospital days in the ICU [ Time Frame: discharg from hospital, 28days,90days ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Etiology, Epidemiology and Prognostics of Acute Kidney Injury (AKI)
Official Title The Study of Etiology, Epidemiology and Prognostic Factors of Acute Kidney Injury
Brief Summary
  • 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.
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.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
1ml whole blood and 1ml serum will obtained within 24 hour after AKI for hematological and biochemistry analyze.
Sampling Method Non-Probability Sample
Study Population Patients selected from a university-affiliated hospital in Shanghai, China.
Condition
  • Renal Failure
  • Nutrition Disorders
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: August 21, 2019)
651
Original Estimated Enrollment
 (submitted: August 5, 2009)
300
Actual Study Completion Date May 2019
Actual Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 16 Years to 88 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries China
Removed Location Countries  
 
Administrative Information
NCT Number NCT00953992
Other Study ID Numbers KY2009-107
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Current Responsible Party Feng Ding,MD, Huashan Hospital
Original Responsible Party Feng Ding, Huashan hospital
Current Study Sponsor Huashan Hospital
Original Study Sponsor Same as current
Collaborators Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Investigators
Principal Investigator: Feng Ding, professor Huashan Hospital
PRS Account Huashan Hospital
Verification Date August 2019