Blood Cultures's Profitability in Intensive Care Unit | NCT02869191

Studies
Blood Cultures's Profitability in Intensive Care Unit

NCT02869191

Sponsor

Hospital Universitario Getafe

Status

Completed

Last Update Posted

Aug 8, 2018Actual

Enrollment

900Actual

Phase

Not provided

Conditions

Bacteremia

Interventions

Not provided

Countries

Spain

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

Aug 2018

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

Oct 2012

Primary Completion Date

Nov 2015Actual

Completion Date

Jul 2018Actual

First Submitted Date

Jul 18, 2012

First Submission Date that Met QC Criteria

Aug 11, 2016

First Posted Date

Aug 16, 2016Estimated

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

Aug 7, 2018

Last Update Posted Date

Aug 8, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Susana Arias Rivera, Registered Nurse, Hospital Universitario GetafePrincipal Investigator

Lead Sponsor

Hospital Universitario GetafeOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

The purpose of this study is to assess the blood cultures' profitability in intensive care unit and create a validated prediction rule for extractioning in critical patients.

Detailed Description

Implementing a predictive rule blood cultures to determine the probability of positive or negative result, improving the profitability of the diagnostic test.

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

900Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
blood cultures		Admitted patients in critical care who need blood cultures
blood cultures Getafe		Data collection of patients included in study

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of positive, negative and contaminated blood cultures		2 years

Secondary Outcomes

Measure	Description	Time Frame
Percentage of positive, negative and contaminated blood cultures after training program	the effect of applying a blood culture extraction protocol is measured	9 months

Other Outcomes

Measure	Description	Time Frame
Contamination rates of blood cultures		1 year

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients who have been extracted blood culture sample

Exclusion Criteria:

Under-aged, pregnants, Major burns.

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

All admitted patients in intensive care unit

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Susana Arias, RN	Hospital Universitario de Getafe	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hopsital Universitario de Getafe		Getafe	Madrid	28905	Spain

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

Condition Browse Module

MeSH Terms

ID	Term
D016470	Bacteremia

Ancestor Terms

ID	Term
D001424	Bacterial Infections
D001423	Bacterial Infections and Mycoses
D007239	Infections
D018805	Sepsis

Browse Leaves

Not provided

Browse Branches

Not provided