Current partner codePEPTIDESDE
NCT03698877·Not applicable·OBSERVATIONAL

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

Status

Completed

Phase

Not applicable

Enrollment

79

Locations

1

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

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.

Full detailed 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.

Interventions

Treatment arms and agents.

DIAGNOSTIC_TEST

Brain Natriuretic Protein (BNP) and Procalcitonin (PCT) blood tests

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.

Timeline

From registration to results.

  1. First posted

    Oct 9, 2018

  2. Study start

    Dec 26, 2018

  3. Primary completion

    Apr 30, 2022

  4. Study completion

    Apr 30, 2022

  5. Results posted

    Not reported

  6. Registry updated

    Oct 19, 2023

Outcomes

What the study measures.

Primary outcomes

Procalcitonin (ng/mL)

Time frame · 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

Time frame · 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).

Secondary outcomes

Not reported in the indexed record.

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
Not reported
Sex
ALL
Healthy volunteers
No

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.

Study locations

1 registered sites.

United States. Showing up to 24 locations stored in the fast local snapshot.

The Rogosin Institute

New York, New York, United States

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

Related trials

More studies on Nesiritide.

Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.