Clinical trial NCT05585970: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Kidney Disease Patients Who Don't Have Infection
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2022-10-19
Enrollment: 50
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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


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

Primary outcomes:
measure: procalcitonin Level
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag University Hospital
Study officials:
References:
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.
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.
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.
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.