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

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.

Study Overview

• Status: Completed
• Conditions: Hemodialysis Catheter Infection

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.

• Study Type: Observational
• Enrollment (Actual): 28

Contacts and Locations

Study Locations

• Saudi Arabia
  • Jeddah, Saudi Arabia
    • New jeddah clinic Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Hemodialysis patients with clinical signs of CRBSI

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
C Reactive Protein	Level of C reactive protein	2 minutes after start of fever/chills or other symptoms suggesting CRBSI
erythrocyte sedimentation rate	erythrocyte sedimentation rate	2 minutes after start of fever/chills or other symptoms suggesting CRBSI
Urea Reduction Rate	Urea Reduction rate	up to 30 days prior to start of fever/chills or other symptoms suggesting CRBSI
creatinine	predialysis Serum creatinine	up to 30 days prior to start of fever/chills or other symptoms suggesting CRBSI
ferritin	predialysis Serum ferritin	up to 30 days prior to start of fever/chills or other symptoms suggesting CRBSI
Hemoglobin	Hemoglobin	up to 30 days prior to start of fever/chills or other symptoms suggesting CRBSI
potassium	predialysis serum potassium	up to 30 days prior to start of fever/chills or other symptoms suggesting CRBSI
Sodium	predialysis serum sodium	up to 30 days prior to start of fever/chills or other symptoms suggesting CRBSI

Collaborators and Investigators

• Sponsor: Benha University
• Collaborators: New Jeddah Clinic Hospital
• Investigators: Principal Investigator: Mahmoud H Imam, MD, Benha University

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 1, 2016
• Primary Completion (ACTUAL): February 28, 2017
• Study Completion (ACTUAL): March 1, 2017

Study Registration Dates

• First Submitted: January 30, 2017
• First Submitted That Met QC Criteria: January 31, 2017
• First Posted (ESTIMATE): February 1, 2017

Study Record Updates

• Last Update Posted (ACTUAL): July 17, 2017
• Last Update Submitted That Met QC Criteria: July 13, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Bacterial Infections; Bacterial Infections and Mycoses; Sepsis; Bacteremia
• Other Study ID Numbers: 17a1b

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No