Clinical trial NCT03039777: Procalcitonin Level as a Surrogate for Catheter-related Blood Stream Bacteremia Among Hemodialysis Patients
Official title: Procalcitonin Level as a Surrogate for Catheter-related Blood Stream Bacteremia Among Hemodialysis Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hemodialysis Catheter Infection
Lead sponsor: Benha University
Sponsor class: OTHER
Collaborators: name: New Jeddah Clinic Hospital
First posted: 2017-02-01
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hemodialysis patients with clinical signs of CRBSI

Brief summary: Hemodialysis patients frequently develop catheter-related blood stream bacteremia (CRBSI). Procalcitonin is a marker of sepsis in bacterial infection. this study for detection of its role as a surrogacy marker in CRBSI.

Detailed description: Catheter-related blood stream bacteremia is common among hemodialysis patients. Clinically, fever and/or rigors with laboratory indicator of inflammation as leucocytosis and elevated c-reactive protein level are considered as markers for CRBSI before blood culture results became available.

Procalcitonin is a valid indicator of sepsis. In this study, Procalcitonin level will be measured in any patient with suspected CRBSI and correlation will be tested for proved CRBSI by blood cultures.

Eligibility criteria: Inclusion Criteria:

* Hemodialysis patients with a dialysis catheter
* signs suggestive of CRBSI: fever/chills or leucocytosis with no other site of infection.
* Informed consent signed to be enrolled in the study

Exclusion Criteria:

* Patient with identified cause of fever other than CRBSI

Primary outcomes:
measure: Procalcitonin Level
timeFrame: 2 minutes after start of fever/chills or other symptoms suggesting CRBSI
Secondary outcomes:
Other outcomes:
measure: Blood culture (central and peripheral) results
timeFrame: 5 minutes after start of fever/chills or other symptoms suggesting CRBSI
measure: C Reactive Protein
timeFrame: 2 minutes after start of fever/chills or other symptoms suggesting CRBSI
measure: erythrocyte sedimentation rate
timeFrame: 2 minutes after start of fever/chills or other symptoms suggesting CRBSI
measure: Urea Reduction Rate
timeFrame: up to 30 days prior to start of fever/chills or other symptoms suggesting CRBSI
measure: creatinine
timeFrame: up to 30 days prior to start of fever/chills or other symptoms suggesting CRBSI
measure: ferritin
timeFrame: up to 30 days prior to start of fever/chills or other symptoms suggesting CRBSI
measure: Hemoglobin
timeFrame: up to 30 days prior to start of fever/chills or other symptoms suggesting CRBSI
measure: potassium
timeFrame: up to 30 days prior to start of fever/chills or other symptoms suggesting CRBSI
measure: Sodium
timeFrame: up to 30 days prior to start of fever/chills or other symptoms suggesting CRBSI
Locations:
city: Jeddah
country: Saudi Arabia
facility: New jeddah clinic Hospital
Study officials:
affiliation: Benha University
name: Mahmoud H Imam, MD
role: PRINCIPAL_INVESTIGATOR
References: