Procalcitonin and Brain Natriuretic Peptides in Patients With Chronic Kidney Disease.

The study has three purposes:

1. 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;

2. 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);

3. 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:

1. Review of medical and medication history

2. A physical exam and routine clinical laboratory tests (hematology and chemistry) will be
performed.

3. PCT and BNP levels will be measured twice prior to hemodialysis (HD) treatment to
establish baseline levels.

4. 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:

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:

1. 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.

2. 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.

Inclusion Criteria:

1. Males and females, 18 years and older.

2. Subject is receiving hemodialysis.

3. Able to provide informed consent.

Exclusion Criteria:

1. Subject is unable or unwilling to provide informed consent.