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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

January 30, 2017
February 1, 2017
July 17, 2017
September 1, 2016
February 28, 2017   (Final data collection date for primary outcome measure)
Procalcitonin Level [ Time Frame: 2 minutes after start of fever/chills or other symptoms suggesting CRBSI ]
Level of serum procalcitonin
Same as current
Complete list of historical versions of study NCT03039777 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
  • 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
  • C Reactive Protein [ Time Frame: 2 minutes after start of fever/chills or other symptoms suggesting CRBSI ]
    Level of C reactive protein
  • erythrocyte sedimentation rate [ Time Frame: 2 minutes after start of fever/chills or other symptoms suggesting CRBSI ]
    erythrocyte sedimentation rate
  • Urea Reduction Rate [ Time Frame: up to 30 days prior to start of fever/chills or other symptoms suggesting CRBSI ]
    Urea Reduction rate
  • creatinine [ Time Frame: up to 30 days prior to start of fever/chills or other symptoms suggesting CRBSI ]
    predialysis Serum creatinine
  • ferritin [ Time Frame: up to 30 days prior to start of fever/chills or other symptoms suggesting CRBSI ]
    predialysis Serum ferritin
  • Hemoglobin [ Time Frame: up to 30 days prior to start of fever/chills or other symptoms suggesting CRBSI ]
    Hemoglobin
  • potassium [ Time Frame: up to 30 days prior to start of fever/chills or other symptoms suggesting CRBSI ]
    predialysis serum potassium
  • Sodium [ Time Frame: up to 30 days prior to start of fever/chills or other symptoms suggesting CRBSI ]
    predialysis serum sodium
Same as current
 
Procalcitonin Level as a Surrogate for Catheter-related Blood Stream Bacteremia Among Hemodialysis Patients
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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
Hemodialysis patients with clinical signs of CRBSI
Hemodialysis Catheter Infection
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
28
Same as current
March 1, 2017
February 28, 2017   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Saudi Arabia
 
 
NCT03039777
17a1b
No
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: No
Mahmoud Hamada imam, Benha University
Benha University
New Jeddah Clinic Hospital
Principal Investigator: Mahmoud H Imam, MD Benha University
Benha University
July 2017