Urine and Serum Biomarkers for Early Detection of Acute Kidney Injury
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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 |
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 |
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)
Contacts and Locations| 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:
|
Heart Diseases Acute Kidney Injury Heart Defects, Congenital Cardiovascular Diseases Renal Insufficiency |
Kidney Diseases Urologic Diseases Cardiovascular Abnormalities Congenital Abnormalities |
ClinicalTrials.gov processed this record on May 23, 2013