Urine and Serum Biomarkers for Early Detection of Acute Kidney Injury
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ClinicalTrials.gov Identifier: NCT01531985 |
Recruitment Status :
Completed
First Posted : February 13, 2012
Last Update Posted : May 8, 2012
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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 |
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Congenital Heart Disease |

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 |


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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 |
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)

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 ClinicalTrials.gov identifier (NCT number): NCT01531985
Principal Investigator: | Michael G Earing, MD | Medical College of Wisconsin/Children's Hospital of Wisconsin |
Responsible Party: | Michael Earing, Associate Professor, Pediatrics, Cardiology, Medical College of Wisconsin |
ClinicalTrials.gov 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 |
Congenital Heart Disease Acute Kidney Injury Cardiopulmonary Bypass Biomarkers |
Acute Kidney Injury Heart Diseases Heart Defects, Congenital Cardiovascular Diseases Renal Insufficiency |
Kidney Diseases Urologic Diseases Cardiovascular Abnormalities Congenital Abnormalities |