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

Hemodialysis Catheter Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03039777
• Other study ID #: 17a1b
• Status: Completed
• Phase: N/A
• First received: January 30, 2017
• Last updated: July 13, 2017
• Start date: September 1, 2016
• Est. completion date: March 1, 2017

Study information

• Verified date: July 2017
• Source: Benha University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: March 1, 2017
• Est. primary completion date: February 28, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bacteremia
• Hemodialysis Catheter Infection

Locations

Country	Name	City	State
Saudi Arabia	New jeddah clinic Hospital	Jeddah

Sponsors (2)

Lead Sponsor	Collaborator
Benha University	New Jeddah Clinic Hospital

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

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