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

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.

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Key information

Conditions

Kidney Failure, Chronic Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The Rogosin Institute

New York, 10021, United States

About this study

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:

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Males and females, 18 years and older.
Subject is receiving hemodialysis.
Able to provide informed consent.

Exclusion criteria

Subject is unable or unwilling to provide informed consent.

Treatment and study plan

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.

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).

Sponsors and collaborators

Lead sponsor

The Rogosin Institute

Other

Collaborators

Weill Medical College of Cornell University

Registry information

Important dates

Study start: 2018
Primary completion: 2022
Study completion: 2022
First posted: Oct 9, 2018
Registry last updated: Oct 19, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed