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

NCT ID: NCT05585970

Last Updated: 2022-10-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-01

Study Completion Date

2023-05-01

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

Detailed Description

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Conditions

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Chronic Kidney Disease Patients Who Don't Have Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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healthy Control individuals

Group Type ACTIVE_COMPARATOR

procalcitonin

Intervention Type DIAGNOSTIC_TEST

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

CKD patients

Group Type ACTIVE_COMPARATOR

procalcitonin

Intervention Type DIAGNOSTIC_TEST

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

ESRD on regular hemodialysis

Group Type ACTIVE_COMPARATOR

procalcitonin

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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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

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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Kidney function tests . ESR. CRP. CBC

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
Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Sohag University

OTHER

Sponsor Role lead

Responsible Party

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Rofida Saadeldin Farghaly

resident doctor at CLINICAL PATHOLOGY department

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Sohag University Hospital

Sohag, , Egypt

Site Status

Countries

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Egypt

Central Contacts

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Rofyda S Gadallah, resident doctor

Role: CONTACT

01026015355

Elham O Hamd, professor

Role: CONTACT

Facility Contacts

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Magdy M Amin, professor

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 23152294 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29456212 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20007347 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 14975050 (View on PubMed)

Other Identifiers

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Soh-Med-22-10-06

Identifier Type: -

Identifier Source: org_study_id

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