Procalcitonin Level as a Surrogate for Catheter-related Blood Stream Bacteremia Among Hemodialysis Patients

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03039777

Enrollment

Registered

2017-02-01

Start date

2016-09-01

Completion date

2017-03-01

Last updated

2017-07-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hemodialysis Catheter Infection

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Procalcitonin Level	2 minutes after start of fever/chills or other symptoms suggesting CRBSI	Level of serum procalcitonin

Other

Measure	Time frame	Description
C Reactive Protein	2 minutes after start of fever/chills or other symptoms suggesting CRBSI	Level of C reactive protein
erythrocyte sedimentation rate	2 minutes after start of fever/chills or other symptoms suggesting CRBSI	erythrocyte sedimentation rate
Urea Reduction Rate	up to 30 days prior to start of fever/chills or other symptoms suggesting CRBSI	Urea Reduction rate
creatinine	up to 30 days prior to start of fever/chills or other symptoms suggesting CRBSI	predialysis Serum creatinine
Blood culture (central and peripheral) results	5 minutes after start of fever/chills or other symptoms suggesting CRBSI	Blood cultures organism growth results (positive/negative) confirming CRBSI
Hemoglobin	up to 30 days prior to start of fever/chills or other symptoms suggesting CRBSI	Hemoglobin
potassium	up to 30 days prior to start of fever/chills or other symptoms suggesting CRBSI	predialysis serum potassium
Sodium	up to 30 days prior to start of fever/chills or other symptoms suggesting CRBSI	predialysis serum sodium
ferritin	up to 30 days prior to start of fever/chills or other symptoms suggesting CRBSI	predialysis Serum ferritin

Countries

Saudi Arabia

Outcome results