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

NCT01503710 | Unknown DMC

• 1 other identifier: 201105047RC
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Renal Failure; Acute Kidney Injury

Keywords

Proteinuria predict outcome; BNP and NGAL predict outcome; Pre-operative GFR and proteinuria

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Taiwan University Hospital: lead
• National Science and Technology Council, Taiwan: collaborator

Study Sites (1)

Wen-Je Ko

Taipei, Taiwan, 10002, Taiwan

RECRUITING

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.

MeSH Terms

Conditions

Acute Kidney Injury; Proteinuria

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urination Disorders; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• V C Wu, M.D., Ph.D.

  Section of Nephrology, Department of Internal Medicine, National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

G H Young, Ph.D.

CONTACT

886-2-2312-3456; r6623612@ms24.hinet.net

W J Ko, M.D.,Ph.D.

CONTACT

886-2-2312-3456; kowj@ntu.edu.tw

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 2, 2012
• First Posted: January 4, 2012
• Study Start: June 1, 2011
• Primary Completion: August 1, 2011
• Study Completion: July 1, 2012
• Last Updated: January 4, 2012

Record last verified: 2011-07

Locations

TW (1)