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Urine and Serum Biomarkers for Early Detection of Acute Kidney Injury

This study has been completed.
Sponsor:
Collaborator:
Children's Hospital and Health System Foundation, Wisconsin
Information provided by (Responsible Party):
Michael Earing, Medical College of Wisconsin
ClinicalTrials.gov Identifier:
NCT01531985
First received: February 9, 2012
Last updated: May 7, 2012
Last verified: May 2012
  Purpose

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
Congenital Heart Disease

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Medical College of Wisconsin:

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.


Enrollment: 20
Study Start Date: April 2010
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   2 Years and older
Genders Eligible for Study:   Both
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.

Criteria

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)
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01531985

Sponsors and Collaborators
Medical College of Wisconsin
Children's Hospital and Health System Foundation, Wisconsin
Investigators
Principal Investigator: Michael G Earing, MD Medical College of Wisconsin/Children's Hospital of Wisconsin
  More Information

Publications:
Responsible Party: Michael Earing, Associate Professor, Pediatrics, Cardiology, Medical College of Wisconsin
ClinicalTrials.gov Identifier: NCT01531985     History of Changes
Other Study ID Numbers: CHW 10/51; GC 1069
Study First Received: February 9, 2012
Last Updated: May 7, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Medical College of Wisconsin:
Congenital Heart Disease
Acute Kidney Injury
Cardiopulmonary Bypass
Biomarkers

Additional relevant MeSH terms:
Acute Kidney Injury
Heart Defects, Congenital
Heart Diseases
Cardiovascular Abnormalities
Cardiovascular Diseases
Congenital Abnormalities
Kidney Diseases
Renal Insufficiency
Urologic Diseases

ClinicalTrials.gov processed this record on November 27, 2014