NCT05585970

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 16, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 19, 2022

Completed
13 days until next milestone

Study Start

First participant enrolled

November 1, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2023

Completed
Last Updated

October 19, 2022

Status Verified

October 1, 2022

Enrollment Period

6 months

First QC Date

October 16, 2022

Last Update Submit

October 18, 2022

Conditions

Chronic Kidney Disease Patients Who Don't Have Infection

Outcome Measures

Primary Outcomes (1)

  • procalcitonin Level

    6 months

Study Arms (3)

healthy Control individuals

ACTIVE COMPARATOR
Diagnostic Test: procalcitonin

CKD patients

ACTIVE COMPARATOR
Diagnostic Test: procalcitonin

ESRD on regular hemodialysis

ACTIVE COMPARATOR
Diagnostic Test: procalcitonin

Interventions

procalcitoninDIAGNOSTIC_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

Also known as: Kidney function tests . ESR. CRP. CBC
CKD patientsESRD on regular hemodialysishealthy Control individuals

Eligibility Criteria

Age40 Years - 80 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Chronic Kidney Disease patients.
  • ESRD patients

You may not qualify if:

  • Any condition of infection or sepsis such as :
  • Fever
  • Increased TLC above normal
  • Tachycardia
  • Tachypnea
  • Disturbed conscious level

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sohag University Hospital

Sohag, Egypt

Location

Related Publications (4)

  • 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.

    PMID: 23152294BACKGROUND

  • 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.

    PMID: 29456212BACKGROUND

  • 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.

    PMID: 20007347BACKGROUND

  • 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.

    PMID: 14975050BACKGROUND

Central Study Contacts

Rofyda S Gadallah, resident doctor

CONTACT

01026015355rofaydahsaad@med.sohag.edu.eg

Elham O Hamd, professor

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
resident doctor at CLINICAL PATHOLOGY department

Study Record Dates

First Submitted

October 16, 2022

First Posted

October 19, 2022

Study Start

November 1, 2022

Primary Completion

May 1, 2023

Study Completion

May 1, 2023

Last Updated

October 19, 2022

Record last verified: 2022-10

Locations

EG(1)