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

NCT ID: NCT02325258

Last Updated: 2014-12-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-08-31

Study Completion Date

2013-01-31

Brief Summary

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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

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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.

Conditions

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Sepsis

Keywords

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Sepsis diagnosis Sepsis drug therapy Sepsis outcome

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Telephone call

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

Group Type EXPERIMENTAL

Telephone call

Intervention Type OTHER

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.

No telephone call

control arm: no intervention

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Telephone call

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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Emilio Bouza

OTHER

Sponsor Role lead

Responsible Party

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Emilio Bouza

Head of Department

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Emilio Bouza Santiago, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Servicio de Microbiología y Enfermedades Infecciosas

Eleonora Bunsow, MD, PhD

Role: STUDY_DIRECTOR

Servicio de Microbiología y Enfermedades Infecciosas

Marcela González Del Vecchio, MD

Role: STUDY_CHAIR

Servicio de Microbiología y Enfermedades Infecciosas

Carlos Sánchez, PharmD

Role: STUDY_CHAIR

Servicio de Microbiología y Enfermedades Infecciosas

Patricia Muñoz García, MD, PhD

Role: STUDY_CHAIR

Servicio de Microbiología y Enfermedades Infecciosas

Almudena Burillo, MD, PhD

Role: STUDY_CHAIR

Servicio de Microbiología y Enfermedades Infecciosas

Locations

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Servicio de Microbiologia y Enfermedades Infecciosas

Madrid, Madrid, Spain

Site Status

Countries

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Spain

References

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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.

Reference Type DERIVED
PMID: 26426609 (View on PubMed)

Other Identifiers

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MICRO.HGUGM.2012-001

Identifier Type: -

Identifier Source: org_study_id