Comparison of Procalcitonin Level in Normal Population and in Chronic Kidney Disease Patients Who Don't Have Infection
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
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Rofyda S Gadallah, resident doctor
- Phone Number: 01026015355
- Email: rofaydahsaad@med.sohag.edu.eg
Study Contact Backup
- Name: Elham O Hamd, professor
Study Locations
-
-
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Sohag, Egypt
- Sohag University Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Active Comparator: healthy Control individuals
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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
Other Names:
|
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Active Comparator: CKD patients
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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
Other Names:
|
|
Active Comparator: ESRD on regular hemodialysis
|
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
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
procalcitonin Level
Time Frame: 6 months
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6 months
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Chan YL, Tseng CP, Tsay PK, Chang SS, Chiu TF, Chen JC. Procalcitonin as a marker of bacterial infection in the emergency department: an observational study. Crit Care. 2004 Feb;8(1):R12-20. doi: 10.1186/cc2396. Epub 2003 Nov 20.
- Rosengren BI, Sagstad SJ, Karlsen TV, Wiig H. Isolation of interstitial fluid and demonstration of local proinflammatory cytokine production and increased absorptive gradient in chronic peritoneal dialysis. Am J Physiol Renal Physiol. 2013 Jan 15;304(2):F198-206. doi: 10.1152/ajprenal.00293.2012. Epub 2012 Nov 14.
- Hamad A, Ismail H, Elsayed M, Kaddourah A, Ahmed H, Ibrahim R, Ali A, Alali F. The epidemiology of acute peritonitis in end-stage renal disease patients on peritoneal dialysis in Qatar: An 8-year follow-up study. Saudi J Kidney Dis Transpl. 2018 Jan-Feb;29(1):88-94. doi: 10.4103/1319-2442.225203.
- Kim HJ, Vaziri ND. Contribution of impaired Nrf2-Keap1 pathway to oxidative stress and inflammation in chronic renal failure. Am J Physiol Renal Physiol. 2010 Mar;298(3):F662-71. doi: 10.1152/ajprenal.00421.2009. Epub 2009 Dec 9.
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Soh-Med-22-10-06
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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