NCT03039777

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2016

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2016

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 30, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 1, 2017

Completed
27 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2017

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
Last Updated

July 17, 2017

Status Verified

July 1, 2017

Enrollment Period

6 months

First QC Date

January 30, 2017

Last Update Submit

July 13, 2017

Conditions

Hemodialysis Catheter Infection

Outcome Measures

Primary Outcomes (1)

  • Procalcitonin Level

    Level of serum procalcitonin

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

Other Outcomes (9)

  • Blood culture (central and peripheral) results

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

  • C Reactive Protein

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

  • erythrocyte sedimentation rate

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

  • +6 more other outcomes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Hemodialysis patients with clinical signs of CRBSI

You may qualify if:

  • 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

You may not qualify if:

  • Patient with identified cause of fever other than CRBSI

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New jeddah clinic Hospital

Jeddah, Saudi Arabia

Location

Study Officials

  • Mahmoud H Imam, MD

    Benha University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

January 30, 2017

First Posted

February 1, 2017

Study Start

September 1, 2016

Primary Completion

February 28, 2017

Study Completion

March 1, 2017

Last Updated

July 17, 2017

Record last verified: 2017-07

Data Sharing

IPD Sharing
Will not share

Locations

SA(1)