Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03698877 |
| Other study ID # |
1710018691 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
December 26, 2018 |
| Est. completion date |
April 30, 2022 |
Study information
| Verified date |
October 2023 |
| Source |
The Rogosin Institute |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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.
Description:
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.
