Comparison of Procalcitonin Level in Normal Population and in Chronic Kidney Disease Patients Who Don't Have Infection

Sohag University

Status: Not yet enrolling

Conditions: Chronic Kidney Disease Patients Who Don't Have Infection

Treatments: Diagnostic Test: procalcitonin

Study type: Interventional

Funder types: Other

Identifiers

NCT05585970

Soh-Med-22-10-06

Details and patient eligibility

About

Chronic kidney disease (CKD) is a life threatening condition with high risk of pre-term death and need for dialysis. It is defined as kidney damage that has continued for more than 3 months as characterized by structural or functional abnormalities of the kidney, with or without decreased glomerular filtration rate (GFR). It is also defined as GFR < 60mL/min/1.73 m2 for more than 3 months, with or without structural kidney damage.

The PCT level in healthy individual without infection is below the limit of detection (0.01 ng/mL), and it is significantly elevated under the stimulation of pathogens. However, due to the pre-existing endogenous inflammation that occurs in CKD patients and the impaired kidney clearance, the reference range that applies to the general population may not be appropriate for diagnosing infections in CKD patients. More recently, debate has continued regarding whether the PCT level is increased in CKD patients without infection, and the optimal reference for CKD patients remains undetermined

Enrollment: 50 estimated patients

Sex: Female

Ages: 40 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Chronic Kidney Disease patients.
• ESRD patients

Exclusion criteria

Any condition of infection or sepsis such as :

• Fever
• Increased TLC above normal
• Tachycardia
• Tachypnea
• Disturbed conscious level

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 3 patient groups

healthy Control individuals

Active Comparator group

Treatment:

Diagnostic Test: procalcitonin

CKD patients

Active Comparator group

Treatment:

Diagnostic Test: procalcitonin

ESRD on regular hemodialysis

Active Comparator group

Treatment:

Diagnostic Test: procalcitonin