Procalcitonin Level as a Surrogate for Catheter-related B... | NCT03039777

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

NCT03039777

Sponsor

Benha University

Status

Completed

Last Update Posted

Jul 17, 2017Actual

Enrollment

28Actual

Phase

Not provided

Conditions

Hemodialysis Catheter Infection

Interventions

Not provided

Countries

Saudi Arabia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 1, 2016Actual

Primary Completion Date

Feb 28, 2017Actual

Completion Date

Mar 1, 2017Actual

First Submitted Date

Jan 30, 2017

First Submission Date that Met QC Criteria

Jan 31, 2017

First Posted Date

Feb 1, 2017Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 13, 2017

Last Update Posted Date

Jul 17, 2017Actual

Name	Class
New Jeddah Clinic Hospital	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

28Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Procalcitonin Level	Level of serum procalcitonin	2 minutes after start of fever/chills or other symptoms suggesting CRBSI

Secondary Outcomes

Not provided

Other Outcomes

Measure	Description	Time Frame
Blood culture (central and peripheral) results	Blood cultures organism growth results (positive/negative) confirming CRBSI	5 minutes after start of fever/chills or other symptoms suggesting CRBSI
C Reactive Protein

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Hemodialysis patients with clinical signs of CRBSI

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Mahmoud H Imam, MD	Benha University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
New jeddah clinic Hospital		Jeddah			Saudi Arabia

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided