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

Renal Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00953992
• Other study ID #: KY2009-107
• Status: Completed
• Start date: April 2009
• Est. completion date: May 2019

Study information

• Verified date: August 2019
• Source: Huashan Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 651
• Est. completion date: May 2019
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 88 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Kidney Injury
• Nutrition Disorders
• Renal Failure

Locations

Country	Name	City	State
China	Shanghai Ninth People's Hospital	Shanghai

Sponsors (2)

Lead Sponsor	Collaborator
Huashan Hospital	Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	renal function survival rate days in the hospital days in the ICU		discharg from hospital, 28days,90days