Examining New Diagnostic Tests for Acute Kidney Injury After Heart Surgery
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| ClinicalTrials.gov Identifier: NCT00774137 |
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Recruitment Status :
Completed
First Posted : October 17, 2008
Last Update Posted : April 3, 2020
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| Condition or disease |
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| Kidney Failure, Acute Renal Insufficiency |
AKI, which is indicated by a sudden change in serum creatinine levels, is a serious complication that can occur after a patient undergoes CABG or heart valve surgery. People who experience AKI after heart surgery may be at increased risk for post-operative complications, including long-term kidney failure or heart damage. AKI is currently identified by testing serum creatinine levels in the blood, which is the traditional marker of kidney function. However, serum creatinine levels can be affected by other non-kidney-related factors and may not positively identify AKI until 48 hours after it begins. This study will examine three new biomarkers found in urine and blood-urine interleukin 18 (IL-18), neutrophil gelatinase-associated lipocalin (NGAL), and cystatin C-that may be able to predict AKI more effectively and faster than serum creatinine levels. In addition, study researchers will also determine if changes in these biomarkers can predict the severity of AKI more successfully than serum creatinine tests.
This study will enroll people undergoing CABG or heart valve surgery at Yale-New Haven Hospital. Before the surgery and once a day for 5 days after the surgery, blood and urine collection will occur. Study researchers will also review participants' medical records. Twelve months after hospital discharge, participants will return to the clinic for a follow-up visit for repeat blood and urine collection and to complete questionnaires. A portion of blood will be saved for future genetic testing; this is optional.
| Study Type : | Observational |
| Actual Enrollment : | 1550 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | Phase IV Multi Center Validation Study of Novel Biomarkers of Acute Kidney Injury After Cardiac Surgery |
| Study Start Date : | April 2007 |
| Actual Primary Completion Date : | February 2013 |
| Actual Study Completion Date : | February 2014 |
- Changes in serum creatinine levels (absolute and percentage) [ Time Frame: Measured in the 1 week after surgery ]
- Doubling of serum creatinine, use of dialysis, or death [ Time Frame: Measured during hospitalization ]
Biospecimen Retention: Samples With DNA
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| Ages Eligible for Study: | Child, Adult, Older Adult |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
- Adults undergoing CABG surgery or heart valve surgery.
- Children undergoing cardic surgery (requiring CABG) to correct congenital heart defects.
Inclusion Criteria for Adults: (must have at least one of the following)
- Emergent surgery
- Pre-existing kidney impairment (baseline serum creatinine greater than 2 mg/dL)
- Ejection fraction less than 35%
- At least 70 years old
- Diabetes mellitus
- Combined CABG and valve surgery
- Repeat CABG or valve surgery
Exclusion Criteria for Adults:
- Pre-operative acute kidney injury
- Enrolled in a conflicting research study
- Prior kidney transplantation
- Baseline serum creatinine level greater than 4.5 mg/dL
- Nephrotoxic drugs administered pre-operatively
- Surgery for only left ventricular assist device
Inclusion Criteria for Children:
- Undergoing open heart surgery
Exclusion Criteria for Children:
- Pre-existing acute kidney failure (greater than 50% decline in creatinine clearance)
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): NCT00774137
| United States, Colorado | |
| University of Colorado Health Sciences Center | |
| Denver, Colorado, United States, 80262 | |
| United States, Connecticut | |
| Danbury Hospital | |
| Danbury, Connecticut, United States, 06810 | |
| Yale University School of Medicine | |
| New Haven, Connecticut, United States, 06510 | |
| United States, Illinois | |
| University of Chicago School of Medicine | |
| Chicago, Illinois, United States, 60637 | |
| United States, North Carolina | |
| Duke Clinical Research Institute | |
| Durham, North Carolina, United States, 27705 | |
| United States, Ohio | |
| Cincinnati Children's Hospital Medical Center | |
| Cincinnati, Ohio, United States, 45229 | |
| Canada, Ontario | |
| London Health Sciences Centre | |
| London, Ontario, Canada, N6A 4G5 | |
| Canada, Quebec | |
| Montreal Children's Hospital at McGill University Health Centre | |
| Montreal, Quebec, Canada, H3H 1P3 | |
| Principal Investigator: | Chirag R. Parikh, MD, PhD | Yale University |
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Yale University |
| ClinicalTrials.gov Identifier: | NCT00774137 |
| Other Study ID Numbers: |
0603001221 R01HL085757 ( U.S. NIH Grant/Contract ) |
| First Posted: | October 17, 2008 Key Record Dates |
| Last Update Posted: | April 3, 2020 |
| Last Verified: | April 2020 |
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Acute Kidney Injury IL-18 NGAL |
Cystatin C Biomarkers Dialysis |
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Acute Kidney Injury Renal Insufficiency Kidney Diseases Urologic Diseases |