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

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ClinicalTrials.gov Identifier: NCT03039777
Recruitment Status : Completed
First Posted : February 1, 2017
Last Update Posted : July 17, 2017
Sponsor:
Collaborator:
New Jeddah Clinic Hospital
Information provided by (Responsible Party):
Mahmoud Hamada imam, Benha University

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.

Condition or disease
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
Actual Enrollment : 28 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Procalcitonin Level as a Surrogate for Catheter-related Blood Stream Bacteremia Among Hemodialysis Patients
Actual Study Start Date : September 1, 2016
Actual Primary Completion Date : February 28, 2017
Actual Study Completion Date : March 1, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis




Primary Outcome Measures :
  1. Procalcitonin Level [ Time Frame: 2 minutes after start of fever/chills or other symptoms suggesting CRBSI ]
    Level of serum procalcitonin


Other Outcome Measures:
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Hemodialysis patients with clinical signs of CRBSI
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03039777


Locations
Saudi Arabia
New jeddah clinic Hospital
Jeddah, Saudi Arabia
Sponsors and Collaborators
Benha University
New Jeddah Clinic Hospital
Investigators
Principal Investigator: Mahmoud H Imam, MD Benha University

Responsible Party: Mahmoud Hamada imam, Dr., Benha University
ClinicalTrials.gov Identifier: NCT03039777     History of Changes
Other Study ID Numbers: 17a1b
First Posted: February 1, 2017    Key Record Dates
Last Update Posted: July 17, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Bacteremia
Bacterial Infections
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Calcitonin
Bone Density Conservation Agents
Physiological Effects of Drugs