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CompletedNCT03039777Updated Jul 17, 2017

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

An observational study in Hemodialysis Catheter Infection, sponsored by Benha University. Completed at 1 site in Saudi Arabia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-07-17.

Sponsored by Benha University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
28
Ages
18 Years and older
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Hemodialysis Catheter Infection

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In context

Bacteremia

322 studies on the registry are indexed under Bacteremia; 49 are open to participants now.

This study's enrollment of 28 is below the median of 269 across 133 observational studies indexed under Bacteremia.

Browse Bacteremia studies →

Lead sponsor

Benha University is the lead sponsor of 356 studies on the registry; 68 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Hemodialysis patients with clinical signs of CRBSI

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

Exclusion Criteria:

  • Patient with identified cause of fever other than CRBSI
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
28 participants (actual)
Patient registry
No
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What researchers measure

Primary outcomes

  1. Procalcitonin Level

    Level of serum procalcitonin

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

Other outcomes

  1. Blood culture (central and peripheral) results

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

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

  2. C Reactive Protein

    Level of C reactive protein

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

  3. erythrocyte sedimentation rate

    erythrocyte sedimentation rate

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

  4. Urea Reduction Rate

    Urea Reduction rate

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

  5. creatinine

    predialysis Serum creatinine

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

  6. ferritin

    predialysis Serum ferritin

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

  7. Hemoglobin

    Hemoglobin

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

  8. potassium

    predialysis serum potassium

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

  9. Sodium

    predialysis serum sodium

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

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Study locations

1 site
  • New jeddah clinic Hospital
    Jeddah, Saudi Arabia
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 17, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03039777
Lead sponsor
Benha University
Collaborators
New Jeddah Clinic Hospital
Responsible party
Mahmoud Hamada imam (Dr., Benha University) — Principal investigator
First posted
Feb 1, 2017
Start date
Sep 1, 2016
Primary completion
Feb 28, 2017
Completion
Mar 1, 2017
Last update
Jul 17, 2017

Study contacts

Mahmoud H Imam, MD
principal investigator · Benha University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2017. You cannot join it, but the record below documents what was studied.

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