NCT02325258

Brief Summary

The aim of the present study was to evaluate the ability of health-care professionals in addressing sepsis, and the impact of a telephone call upon receival of blood cultures in the clinical microbiology department, from a clinical microbiologist, in the early management of sepsis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
300

participants targeted

Target at P50-P75 for not_applicable sepsis

Timeline
Completed

Started Aug 2012

Shorter than P25 for not_applicable sepsis

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

August 1, 2012

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

December 19, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 24, 2014

Completed
Last Updated

December 30, 2014

Status Verified

December 1, 2014

Enrollment Period

5 months

First QC Date

December 19, 2014

Last Update Submit

December 29, 2014

Conditions

Keywords

Sepsis diagnosisSepsis drug therapySepsis outcome

Outcome Measures

Primary Outcomes (1)

  • Sepsis recognition in patients who had blood cultures drawn

    Use of diagnostic resources and antimicrobial consumption

    72 h

Secondary Outcomes (1)

  • Health care professionals who correctly identify a case of sepsis

    72 h

Study Arms (2)

Telephone call

EXPERIMENTAL

Telephone call to physicians in charge of patients who have just had blood cultures drawn. Diagnostic and therapeutic recommendations to physicians in charge.

Other: Telephone call

No telephone call

NO INTERVENTION

control arm: no intervention

Interventions

Aug-Dec 2012. Prospective study in patients who had blood cultures drawn and sent to the Microbiology Lab during the morning shift (9 am to 3 pm, Mon- Fri) to evaluate sepsis recognition. The investigators allocated 300 patients to 2 groups of 150 patients each, by opportunity sampling: patients whose clinical history number ended in odd numbers were assigned to group A (intervention) and those whose clinical history number ended in even numbers were assigned to group B (no intervention, control group). For patients in group A, the investigators attempted a telephone contact with the physician and/or nurse in charge and an interview, issuing recommendations regarding the convenience of further biochemical, microbiological or extra radiologic tests, and management and antimicrobial therapy.

Telephone call

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who had blood cultures drawn and sent to the Microbiology Laboratory, during the morning shift (from 9 am to 3 pm, Monday to Friday)
  • Patients \>/=18 years old

You may not qualify if:

  • Patients \<18 years old
  • Patients with a recent bacteremic episode with no subsequent negative blood cultures
  • In-patients with blood cultures drawn to whom the telephone call had already been performed.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Servicio de Microbiologia y Enfermedades Infecciosas

Madrid, Madrid, 28007, Spain

Location

Related Publications (1)

  • Bunsow E, Vecchio MG, Sanchez C, Munoz P, Burillo A, Bouza E. Improved Sepsis Alert With a Telephone Call From the Clinical Microbiology Laboratory: A Clinical Trial. Medicine (Baltimore). 2015 Sep;94(39):e1454. doi: 10.1097/MD.0000000000001454.

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Emilio Bouza Santiago, MD, PhD

    Servicio de Microbiología y Enfermedades Infecciosas

    PRINCIPAL INVESTIGATOR
  • Eleonora Bunsow, MD, PhD

    Servicio de Microbiología y Enfermedades Infecciosas

    STUDY DIRECTOR
  • Marcela González Del Vecchio, MD

    Servicio de Microbiología y Enfermedades Infecciosas

    STUDY CHAIR
  • Carlos Sánchez, PharmD

    Servicio de Microbiología y Enfermedades Infecciosas

    STUDY CHAIR
  • Patricia Muñoz García, MD, PhD

    Servicio de Microbiología y Enfermedades Infecciosas

    STUDY CHAIR
  • Almudena Burillo, MD, PhD

    Servicio de Microbiología y Enfermedades Infecciosas

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Head of Department

Study Record Dates

First Submitted

December 19, 2014

First Posted

December 24, 2014

Study Start

August 1, 2012

Primary Completion

January 1, 2013

Study Completion

January 1, 2013

Last Updated

December 30, 2014

Record last verified: 2014-12

Locations