NCT02869191

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
900

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2012

Longer than P75 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

First Submitted

Initial submission to the registry

July 18, 2012

Completed
3 months until next milestone

Study Start

First participant enrolled

October 1, 2012

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
10 months until next milestone

First Posted

Study publicly available on registry

August 16, 2016

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2018

Completed
Last Updated

August 8, 2018

Status Verified

August 1, 2018

Enrollment Period

3.1 years

First QC Date

July 18, 2012

Last Update Submit

August 7, 2018

Conditions

Bacteremia

Outcome Measures

Primary Outcomes (1)

  • Percentage of positive, negative and contaminated blood cultures

    2 years

Secondary Outcomes (1)

  • Percentage of positive, negative and contaminated blood cultures after training program

    9 months

Other Outcomes (1)

  • Contamination rates of blood cultures

    1 year

Study Arms (2)

blood cultures

Admitted patients in critical care who need blood cultures

blood cultures Getafe

Data collection of patients included in study

Eligibility Criteria

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

All admitted patients in intensive care unit

You may qualify if:

  • Patients who have been extracted blood culture sample

You may not qualify if:

  • Under-aged, pregnants, Major burns.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hopsital Universitario de Getafe

Getafe, Madrid, 28905, Spain

Location

MeSH Terms

Conditions

Bacteremia

Condition Hierarchy (Ancestors)

Bacterial InfectionsBacterial Infections and MycosesInfectionsSepsisSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Susana Arias, RN

    Hospital Universitario de Getafe

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Registered Nurse

Study Record Dates

First Submitted

July 18, 2012

First Posted

August 16, 2016

Study Start

October 1, 2012

Primary Completion

November 1, 2015

Study Completion

July 1, 2018

Last Updated

August 8, 2018

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)