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

NCT03698877 | Completed

• 1 other identifier: 1710018691
• Study Type: observational
• Target: 79
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Kidney Failure, Chronic

Outcome Measures

Primary Outcomes (2)

• Procalcitonin (ng/mL)

  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.

  3 years

• Brain Natriuretic Peptide (pg/mL) levels

  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).

  3 years

Interventions

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Potential subjects are those who are receiving hemodialysis at The Rogosin Institute.

You may qualify if:

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

You may not qualify if:

• \. Subject is unable or unwilling to provide informed consent.

Sponsors & Collaborators

• The Rogosin Institute: lead
• Weill Medical College of Cornell University: collaborator

Study Sites (1)

The Rogosin Institute

New York, New York, 10021, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood

MeSH Terms

Conditions

Kidney Failure, Chronic

Interventions

Hematologic Tests

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Jeffrey Silberzweig, MD

  The Rogosin Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 2, 2018
• First Posted: October 9, 2018
• Study Start: December 26, 2018
• Primary Completion: April 30, 2022
• Study Completion: April 30, 2022
• Last Updated: October 19, 2023

Record last verified: 2023-10

Locations

US (1)