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| Name | Class |
|---|---|
| Weill Medical College of Cornell University | OTHER |
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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.
The study has three purposes:
Baseline Visit:
Follow Up:
1. 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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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brain Natriuretic Protein (BNP) and Procalcitonin (PCT) blood tests | Diagnostic Test | 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. 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Procalcitonin (ng/mL) | 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. | 3 years |
| Brain Natriuretic Peptide (pg/mL) levels | 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). | 3 years |
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Inclusion Criteria:
Exclusion Criteria:
1. Subject is unable or unwilling to provide informed consent.
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Potential subjects are those who are receiving hemodialysis at The Rogosin Institute.
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| Name | Affiliation | Role |
|---|---|---|
| Jeffrey Silberzweig, MD | The Rogosin Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Rogosin Institute | New York | New York | 10021 | United States |
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| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
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| ID | Term |
|---|---|
| D006403 | Hematologic Tests |
| ID | Term |
|---|---|
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D008919 | Investigative Techniques |
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Blood
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |