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

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. Identifier: NCT01503710
Recruitment Status : Unknown
Verified July 2011 by National Taiwan University Hospital.
Recruitment status was:  Recruiting
First Posted : January 4, 2012
Last Update Posted : January 4, 2012
National Science Council, Taiwan
Information provided by (Responsible Party):
National Taiwan University Hospital

Brief 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.

Condition or disease
Acute Renal Failure Acute Kidney Injury

Detailed 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.

Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Early Diagnosis of Postoperative Acute Renal Failure - Using Biomarker to Predict the Outcome of Cardiac Surgery Associated Acute Kidney Injury
Study Start Date : June 2011
Actual Primary Completion Date : August 2011
Estimated Study Completion Date : July 2012

Biospecimen Retention:   Samples With DNA
Blood samples are drawn before the first dialysis session after postcardiac sugary associated severe AKI ( initializing RRT). Blood is drawn into Vacutainer tubes containing EDTA, and immediately placed on ice and centrifuged within 1 h. All the samples are stored at -70°C until analysis.

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
patients (cases) that developed AKI during the follow-up period of 72 h. AKI was defined as a 50% or greater increase in SCr from baseline according to the RIFLE-R criteria. For each of these cases, we then selected 20 controls from patients who also underwent open heart surgery but did not develop AKI. We matched the cases and controls as closely as possible for age, sex, baseline estimated GFR, comorbidities, medications, type of surgery and perioperative complications.

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.

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 identifier (NCT number): NCT01503710

Contact: G H Young, Ph.D. 886-2-2312-3456 ext 63638
Contact: W J Ko, M.D.,Ph.D. 886-2-2312-3456 ext 63098

Wen-Je Ko Recruiting
Taipei, Taiwan, 10002
Contact: W J Ko, M.D., Ph.D.    886-2-2312-3456 ext 63098   
Sponsors and Collaborators
National Taiwan University Hospital
National Science Council, Taiwan
Principal Investigator: V C Wu, M.D., Ph.D. Section of Nephrology, Department of Internal Medicine, National Taiwan University Hospital

Responsible Party: National Taiwan University Hospital Identifier: NCT01503710     History of Changes
Other Study ID Numbers: 201105047RC
First Posted: January 4, 2012    Key Record Dates
Last Update Posted: January 4, 2012
Last Verified: July 2011

Keywords provided by National Taiwan University Hospital:
Proteinuria predict outcome
BNP and NGAL predict outcome
Pre-operative GFR and proteinuria

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