Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
Kidney Failure Chronic
Type
Observational
Design
Observational Model: CohortTime Perspective: Prospective

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

Description

The study has three purposes: 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; To establish an algorithm to assist clinicians in distinguishing infection from flu...

The study has three purposes: 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; 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); 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: Review of medical and medication history A physical exam and routine clinical laboratory tests (hematology and chemistry) will be performed. PCT and BNP levels will be measured twice prior to hemodialysis (HD) treatment to establish baseline levels. 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: 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.

Tracking Information

NCT #
NCT03698877
Collaborators
Weill Medical College of Cornell University
Investigators
Principal Investigator: Jeffrey Silberzweig, MD The Rogosin Institute