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

Sponsor
Sohag University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05585970
Collaborator
(none)
50
1
3
5.9
8.4

Study Details

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

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: procalcitonin
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Comparison of Procalcitonin Level in Normal Population and in Chronic Kidney Disease Patients Who Don't Have Infection
Anticipated Study Start Date :
Nov 1, 2022
Anticipated Primary Completion Date :
May 1, 2023
Anticipated Study Completion Date :
May 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: healthy Control individuals

Diagnostic Test: procalcitonin
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:
  • Kidney function tests . ESR. CRP. CBC
  • Active Comparator: CKD patients

    Diagnostic Test: procalcitonin
    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:
  • Kidney function tests . ESR. CRP. CBC
  • Active Comparator: ESRD on regular hemodialysis

    Diagnostic Test: procalcitonin
    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:
  • Kidney function tests . ESR. CRP. CBC
  • Outcome Measures

    Primary Outcome Measures

    1. procalcitonin Level [6 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    40 Years to 80 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Sohag University Hospital Sohag Egypt

    Sponsors and Collaborators

    • Sohag University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Rofida Saadeldin Farghaly, resident doctor at CLINICAL PATHOLOGY department, Sohag University
    ClinicalTrials.gov Identifier:
    NCT05585970
    Other Study ID Numbers:
    • Soh-Med-22-10-06
    First Posted:
    Oct 19, 2022
    Last Update Posted:
    Oct 19, 2022
    Last Verified:
    Oct 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Oct 19, 2022