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Assessment of a Proposed Microbiological Alert and Its Impact on a Sepsis Campaign

Primary Purpose

Sepsis

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Telephone call
Sponsored by
Emilio Bouza
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Sepsis focused on measuring Sepsis diagnosis, Sepsis drug therapy, Sepsis outcome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

In-patients with blood cultures drawn and sent to the Microbiology laboratory, regardless of patient allocation (eg., emergency department, intensive care units, general wards)

Opportunity sampling: patients whose clinical history number ended in odd numbers were assigned to group A (intervention) and patients whose clinical history number ended in even numbers were assigned to group B (no intervention, control group).

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Sites / Locations

  • Servicio de Microbiologia y Enfermedades Infecciosas

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Telephone call

No telephone call

Arm Description

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

control arm: no intervention

Outcomes

Primary Outcome Measures

Sepsis recognition in patients who had blood cultures drawn
Use of diagnostic resources and antimicrobial consumption

Secondary Outcome Measures

Health care professionals who correctly identify a case of sepsis

Full Information

First Posted
December 19, 2014
Last Updated
December 29, 2014
Sponsor
Emilio Bouza
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1. Study Identification

Unique Protocol Identification Number
NCT02325258
Brief Title
Assessment of a Proposed Microbiological Alert and Its Impact on a Sepsis Campaign
Official Title
Assessment of a Proposed Microbiological Alert and Its Impact on a Sepsis Campaign
Study Type
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
August 2012 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
January 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Emilio Bouza

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Sepsis is one of the major challenges of modern medicine. It is an important health problem with a high incidence, morbidity and mortality that affects population worldwide. Without an early recognition and a prompt management, patients can develop more severe stages of the disease and even death. An appropriate and aggressive management can significantly improve outcomes. Thus, it is necessary to develop early warning systems of sepsis in the hospital. In recent years, several campaigns and guidelines have been developed to help health care professionals in the management of sepsis. However, these have mainly focused on management protocols for severe sepsis and septic shock in intensive care units or emergency departments. To the best of the investigators knowledge, none of these have examined in depth either the impact of a sepsis alert system in general wards, nor the impact of a telephone call from a specialist in Clinical Microbiology, upon blood culture request, in the early recognition of sepsis. 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. For this, the investigators performed a prospective study based on telephone calls followed by a phone interview to physicians and nurses in charge of patients whose blood cultures had just been received at the clinical microbiology department in a tertiary hospital.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sepsis
Keywords
Sepsis diagnosis, Sepsis drug therapy, Sepsis outcome

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
300 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Telephone call
Arm Type
Experimental
Arm Description
Telephone call to physicians in charge of patients who have just had blood cultures drawn. Diagnostic and therapeutic recommendations to physicians in charge.
Arm Title
No telephone call
Arm Type
No Intervention
Arm Description
control arm: no intervention
Intervention Type
Other
Intervention Name(s)
Telephone call
Intervention Description
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.
Primary Outcome Measure Information:
Title
Sepsis recognition in patients who had blood cultures drawn
Description
Use of diagnostic resources and antimicrobial consumption
Time Frame
72 h
Secondary Outcome Measure Information:
Title
Health care professionals who correctly identify a case of sepsis
Time Frame
72 h

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
In-patients with blood cultures drawn and sent to the Microbiology laboratory, regardless of patient allocation (eg., emergency department, intensive care units, general wards) Opportunity sampling: patients whose clinical history number ended in odd numbers were assigned to group A (intervention) and patients whose clinical history number ended in even numbers were assigned to group B (no intervention, control group). Inclusion Criteria: 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 Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emilio Bouza Santiago, MD, PhD
Organizational Affiliation
Servicio de Microbiología y Enfermedades Infecciosas
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Eleonora Bunsow, MD, PhD
Organizational Affiliation
Servicio de Microbiología y Enfermedades Infecciosas
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Marcela González Del Vecchio, MD
Organizational Affiliation
Servicio de Microbiología y Enfermedades Infecciosas
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Carlos Sánchez, PharmD
Organizational Affiliation
Servicio de Microbiología y Enfermedades Infecciosas
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Patricia Muñoz García, MD, PhD
Organizational Affiliation
Servicio de Microbiología y Enfermedades Infecciosas
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Almudena Burillo, MD, PhD
Organizational Affiliation
Servicio de Microbiología y Enfermedades Infecciosas
Official's Role
Study Chair
Facility Information:
Facility Name
Servicio de Microbiologia y Enfermedades Infecciosas
City
Madrid
ZIP/Postal Code
28007
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
26426609
Citation
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.
Results Reference
derived

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Assessment of a Proposed Microbiological Alert and Its Impact on a Sepsis Campaign

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