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

Study Overview
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Brief Summary
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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

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

Conditions
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Chronic Kidney Disease Patients Who Don't Have Infection

Intervention / Treatment
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* Diagnostic Test: procalcitonin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: healthy Control individuals<br> | Diagnostic Test: procalcitonin<br>* 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<br>* Other names: Kidney function tests . ESR. CRP. CBC;|
| Active Comparator: CKD patients<br> | Diagnostic Test: procalcitonin<br>* 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<br>* Other names: Kidney function tests . ESR. CRP. CBC;|
| Active Comparator: ESRD on regular hemodialysis<br> | Diagnostic Test: procalcitonin<br>* 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<br>* Other names: Kidney function tests . ESR. CRP. CBC;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| procalcitonin Level |  | 6 months |