Procalcitonin and Brain Natriuretic Peptides in Patients With Chronic Kidney Disease.
Study Details
Study Description
Brief Summary
The study is being conducted to determine if the blood test Brain Natriuretic Protein (BNP) can demonstrate the presence of extra fluid in patients with chronic kidney disease treated by hemodialysis. It will also try to determine the blood test Procalcitonin (PCT) can help identify the cause of the fever, specifically if a fever is caused by a bacterial infection. It will also evaluate whether new blood tests in the future (such as DNA, RNA, metabolite, and protein based tests) can be developed to help predict other complications in patients with chronic kidney disease treated by hemodialysis.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed Description
The study has three purposes:
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To establish a procalcitonin (PCT) algorithm to assist in the identification of bacterial infection in patients with fever and chronic kidney disease (CKD) being treated by hemodialysis;
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To establish an algorithm to assist clinicians in distinguishing infection from fluid overload in patients with CKD treated by hemodialysis with shortness of breath using PCT and brain natriuretic peptide (BNP);
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To allow for evaluation of new tests, such as DNA, RNA, metabolite, and protein based tests, which might prove useful in the evaluation of clinical complications encountered by patients with chronic kidney disease treated by hemodialysis including infections and fluid overload.
Baseline Visit:
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Review of medical and medication history
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A physical exam and routine clinical laboratory tests (hematology and chemistry) will be performed.
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PCT and BNP levels will be measured twice prior to hemodialysis (HD) treatment to establish baseline levels.
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Optional: If the subject consent, samples will be obtained for genetic tests (DNA, RNA, metabolite and proteins) for new tests to be developed in the future.
Follow Up:
- A physical exam, routine clinical laboratory tests (hematology and chemistry) and medical and medication review will be obtained monthly.
If a subject develops signs of infection or shortness of breath during the course of the study, additional research blood samples for procalcitonin, brain natriuretic peptide, and for genetic testing (Optional) will be obtained as follows:
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For patients with suspected infection, PCT levels will be drawn at the time of suspected infection and again at the start of the next HD treatment.
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For patients with shortness of breath, PCT and BNP levels will be drawn at the time of the complaint and again at the start of the next HD treatment.
Study Design
Outcome Measures
Primary Outcome Measures
- Procalcitonin (ng/mL) [3 years]
To establish a procalcitonin (PCT) algorithm to assist in the identification of bacterial infection in patients with fever and chronic kidney disease being treated by hemodialysis, PCT levels will be obtained and compared to blood cultures.
- Brain Natriuretic Peptide (pg/mL) levels [3 years]
To distinguish infection from fluid overload, Brain Natriuretic Peptide (BNP) levels will be measured and combined with PCT levels and compared to blood cultures, blood pressure changes and weight (kg).
Eligibility Criteria
Criteria
Inclusion Criteria:
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Males and females, 18 years and older.
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Subject is receiving hemodialysis.
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Able to provide informed consent.
Exclusion Criteria:
- Subject is unable or unwilling to provide informed consent.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | The Rogosin Institute | New York | New York | United States | 10021 |
Sponsors and Collaborators
- The Rogosin Institute
- Weill Medical College of Cornell University
Investigators
- Principal Investigator: Jeffrey Silberzweig, MD, The Rogosin Institute
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 1710018691