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Completed

NCT Number: NCT03039777

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.

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Key information

Conditions

Hemodialysis Catheter Infection

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

New jeddah clinic Hospital

Jeddah, Saudi Arabia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Procalcitonin Level

    Time frame: 2 minutes after start of fever/chills or other symptoms suggesting CRBSI

    Level of serum procalcitonin

Other outcomes

  1. Blood culture (central and peripheral) results

    Time frame: 5 minutes after start of fever/chills or other symptoms suggesting CRBSI

    Blood cultures organism growth results (positive/negative) confirming CRBSI

  2. C Reactive Protein

    Time frame: 2 minutes after start of fever/chills or other symptoms suggesting CRBSI

    Level of C reactive protein

  3. erythrocyte sedimentation rate

    Time frame: 2 minutes after start of fever/chills or other symptoms suggesting CRBSI

    erythrocyte sedimentation rate

  4. Urea Reduction Rate

    Time frame: up to 30 days prior to start of fever/chills or other symptoms suggesting CRBSI

    Urea Reduction rate

  5. creatinine

    Time frame: up to 30 days prior to start of fever/chills or other symptoms suggesting CRBSI

    predialysis Serum creatinine

  6. ferritin

    Time frame: up to 30 days prior to start of fever/chills or other symptoms suggesting CRBSI

    predialysis Serum ferritin

  7. Hemoglobin

    Time frame: up to 30 days prior to start of fever/chills or other symptoms suggesting CRBSI

    Hemoglobin

  8. potassium

    Time frame: up to 30 days prior to start of fever/chills or other symptoms suggesting CRBSI

    predialysis serum potassium

  9. Sodium

    Time frame: up to 30 days prior to start of fever/chills or other symptoms suggesting CRBSI

    predialysis serum sodium

Sponsors and collaborators

Lead sponsor

Benha University

Other

Collaborators

  • New Jeddah Clinic Hospital

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Feb 1, 2017
Registry last updated
Jul 17, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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