Comparison of Procalcitonin Level in Normal Population and in Chronic Kidney Disease Patients Who Don't Have Infection
Primary Purpose
Chronic Kidney Disease Patients Who Don't Have Infection
Status
Not yet recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
procalcitonin
Sponsored by
About this trial
This is an interventional diagnostic trial for Chronic Kidney Disease Patients Who Don't Have Infection
Eligibility Criteria
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
Sites / Locations
- Sohag University Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
healthy Control individuals
CKD patients
ESRD on regular hemodialysis
Arm Description
Outcomes
Primary Outcome Measures
procalcitonin Level
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05585970
Brief Title
Comparison of Procalcitonin Level in Normal Population and in Chronic Kidney Disease Patients Who Don't Have Infection
Official Title
Comparison of Procalcitonin Level in Normal Population and in Chronic Kidney Disease Patients Who Don't Have Infection
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 1, 2022 (Anticipated)
Primary Completion Date
May 1, 2023 (Anticipated)
Study Completion Date
May 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sohag University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease Patients Who Don't Have Infection
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
healthy Control individuals
Arm Type
Active Comparator
Arm Title
CKD patients
Arm Type
Active Comparator
Arm Title
ESRD on regular hemodialysis
Arm Type
Active Comparator
Intervention Type
Diagnostic Test
Intervention Name(s)
procalcitonin
Other Intervention Name(s)
Kidney function tests . ESR. CRP. CBC
Intervention Description
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
Primary Outcome Measure Information:
Title
procalcitonin Level
Time Frame
6 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rofyda S Gadallah, resident doctor
Phone
01026015355
Email
rofaydahsaad@med.sohag.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
Elham O Hamd, professor
Facility Information:
Facility Name
Sohag University Hospital
City
Sohag
Country
Egypt
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Magdy M Amin, professor
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
23152294
Citation
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.
Results Reference
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PubMed Identifier
29456212
Citation
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.
Results Reference
background
PubMed Identifier
20007347
Citation
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.
Results Reference
background
PubMed Identifier
14975050
Citation
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.
Results Reference
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Comparison of Procalcitonin Level in Normal Population and in Chronic Kidney Disease Patients Who Don't Have Infection
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