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

January 3, 2012 updated by: National Taiwan University Hospital

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

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.

Study Overview

Status

Unknown

Conditions

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

Enrollment (Anticipated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taipei, Taiwan, 10002
        • Recruiting
        • Wen-Je Ko
        • Contact:
          • W J Ko, M.D., Ph.D.
          • Phone Number: 63098 886-2-2312-3456
          • Email: kowj@ntu.edu.tw

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taiwan University Hospital

Collaborators

National Science Council, Taiwan

Investigators

  • Principal Investigator: V C Wu, M.D., Ph.D., Section of Nephrology, Department of Internal Medicine, National Taiwan University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2011

Primary Completion (ACTUAL)

August 1, 2011

Study Completion (ANTICIPATED)

July 1, 2012

Study Registration Dates

First Submitted

January 2, 2012

First Submitted That Met QC Criteria

January 3, 2012

First Posted (ESTIMATE)

January 4, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

January 4, 2012

Last Update Submitted That Met QC Criteria

January 3, 2012

Last Verified

July 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201105047RC

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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