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Urine and Serum Biomarkers for Early Detection of Acute Kidney Injury

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: NCT01531985
Recruitment Status : Completed
First Posted : February 13, 2012
Last Update Posted : May 8, 2012
Children's Hospital and Health System Foundation, Wisconsin
Information provided by (Responsible Party):
Michael Earing, Medical College of Wisconsin

Brief Summary:

The purpose of this study is to find out whether a combination of new urine tests and blood tests can show kidney injury in its early stages, before kidney failure sets in. If the investigators find new tests that show kidney injury in early stages, the investigators hope to start treating people with kidney injury earlier, to prevent kidney failure. You/your child are at higher risk for kidney injury and kidney failure than most other people, because of having operations with cardiopulmonary bypass (a machine that pumps your/your child's blood during the operation). This research is being done because there are no tests yet proven to show kidney injury before it leads to kidney failure.

The urine and blood tests the investigators are studying have each been shown to indicate some degree of kidney injury in certain people, but not with the accuracy needed to diagnose disease. The investigators think that the combination of urine and blood tests being tried in this research study may provide enough information to better diagnose kidney injury at an earlier stage.

About 20 persons over 2 years old up to adults will take part in this study. All will be from the Herma Heart Center of Children's Hospital of Wisconsin.

Condition or disease
Congenital Heart Disease

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Study Type : Observational
Actual Enrollment : 20 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Urine and Serum Biomarkers for Early Detection of Acute Kidney Injury Following Cardiopulmonary Bypass Surgery for Congenital Heart Disease in Children and Adults: A Pilot Study
Study Start Date : April 2010
Actual Primary Completion Date : March 2012
Actual Study Completion Date : March 2012

Resource links provided by the National Library of Medicine

Biospecimen Retention:   Samples Without DNA
Urine samples will be collected after the operation at 6 hours, 12 hours, 24 hours and 72 hours. The urine samples will be collected from your/your child's urinary catheter if one is in place for your/your child's regular hospital care, or by urine collected in a cup if you/your child do not have a urinary catheter. This study requires one blood samples of about 1 teaspoon, before surgery. The blood sample will be collected when other blood samples are drawn, to avoid extra needle sticks for blood. The extra blood collected, totaling about 1 teaspoon, is a safe amount for children over 2 years old.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   2 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The investigators will enroll a total of 20 patients undergoing pulmonary valve replacement with CPB. All patients will have a history of a conotruncal anomaly with previous corrective surgery requiring CPB.

Inclusion Criteria:

  • Patients 2 years of age or older
  • Undergoing pulmonary valve replacement
  • History of conotruncal anomaly ( including tetralogy of fallot, pulmonary atresia/VSD, truncus arteriosus, double outlet right ventricle)

Exclusion Criteria:

  • unable to provide/obtain informed consent
  • solid organ transplant recipients
  • estimated baseline GFR < 30 ml/min (by MDRD-2)

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): NCT01531985

Sponsors and Collaborators
Medical College of Wisconsin
Children's Hospital and Health System Foundation, Wisconsin
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Principal Investigator: Michael G Earing, MD Medical College of Wisconsin/Children's Hospital of Wisconsin
Publications of Results:
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Responsible Party: Michael Earing, Associate Professor, Pediatrics, Cardiology, Medical College of Wisconsin Identifier: NCT01531985    
Other Study ID Numbers: CHW 10/51; GC 1069
First Posted: February 13, 2012    Key Record Dates
Last Update Posted: May 8, 2012
Last Verified: May 2012
Keywords provided by Michael Earing, Medical College of Wisconsin:
Congenital Heart Disease
Acute Kidney Injury
Cardiopulmonary Bypass
Additional relevant MeSH terms:
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Acute Kidney Injury
Heart Diseases
Heart Defects, Congenital
Cardiovascular Diseases
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Cardiovascular Abnormalities
Congenital Abnormalities