Early Diagnosis of Postoperative Acute Renal Failure-using Biomarker to Predict Outcome of Cardiac Surgery Associated Acute Kidney Injury

Acute Kidney Injury Clinical Trial

— NSARF  

Official title:

Early Diagnosis of Postoperative Acute Renal Failure - Using Biomarker to Predict the Outcome of Cardiac Surgery Associated Acute Kidney Injury

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01503710
• Other study ID #: 201105047RC
• Status: Recruiting
• Phase: N/A
• First received: January 2, 2012
• Last updated: January 3, 2012
• Start date: June 2011
• Est. completion date: July 2012

Study information

• Verified date: July 2011
• Source: National Taiwan University Hospital
• Contact: G H Young, Ph.D.
• Phone: 886-2-2312-3456
• Email: r6623612[@]ms24.hinet.net
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to determine soluble HJV could be an early diagnosis urinary biomarker of ischemia/reperfusion injury in post CPB-patients.

Description:

Acute kidney injury (AKI) is a common syndrome on Intensive Care Unit, and renal dysfunction would result in a further morbidity and mortality. Critical ills complicated with acute kidney injury are usually accompanied with multi-organ failure. Therefore, National Taiwan University Hospital Study group of Acute Renal Failure (NSARF) realizes that the characteristics of AKI is resulted from the perfusion less of body fluid and attempt to develop therapies to prevent or attenuate AKI, which have had limited success. We attempt to use the novel biomarker soluble hemojuvelin (sHJV) to evaluate the iron homeostasis on acute kidney injury and develop new strategies and therapies such as protease inhibitors on kidney function, as safety markers to monitor toxicity and as measures of treatment effect. Besides, we will focus on validation the sensitivity and specificity of sHJV on the clinical specimen of post-operative patients from NSARF data-bank. Merge the renal function and other types of biomarkers as panel to predict the post-operative outcome. Based on the different expression of these markers, using a panel of serum and urine markers may potentially help us to distinguish between various types of insults, establish the duration and severity of injury, predict the clinical outcome and help to monitor response to treatment in AKI.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: July 2012
• Est. primary completion date: August 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• AKI is defined as a serum creatinine level greater that 50% more than baseline during the first 3 postoperative days (PODs), and non-AKI, as a less than 10% increase.

Exclusion Criteria:

• Patients with chronic kidney disease (baseline estimated glomerular filtration rate < 60 mL/min/1.73 m2 as calculated by using the 4-variable Modification of Diet in Renal Disease Study equation, or protein-creatinine ratio > 100 mg/mmol) are excluded.

Study Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Acute Kidney Injury
• Acute Renal Failure
• Renal Insufficiency

Locations

Country	Name	City	State
Taiwan	Wen-Je Ko	Taipei

Sponsors (2)

Lead Sponsor	Collaborator
National Taiwan University Hospital	National Science Council, Taiwan

Country where clinical trial is conducted

Taiwan,