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

Sponsor

Emilio Bouza (Other)

Overall Status

Completed

CT.gov ID

NCT02325258

Collaborator

(none)

300

Enrollment

Location

Arms

Duration (Months)

59.7

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Sepsis	Other: Telephone call	N/A

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.

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

300 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Study Start Date :

Aug 1, 2012

Actual Primary Completion Date :

Jan 1, 2013

Actual Study Completion Date :

Jan 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Other: 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.
No Intervention: No telephone call control arm: no intervention

Arm

Intervention/Treatment

Experimental: 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.

Other: 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.

No Intervention: No telephone call

control arm: no intervention

Outcome Measures

Primary Outcome Measures

Sepsis recognition in patients who had blood cultures drawn [72 h]
Use of diagnostic resources and antimicrobial consumption

Secondary Outcome Measures

Health care professionals who correctly identify a case of sepsis [72 h]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Servicio de Microbiologia y Enfermedades Infecciosas	Madrid		Spain	28007

Sponsors and Collaborators

Emilio Bouza

Investigators

Principal Investigator: Emilio Bouza Santiago, MD, PhD, Servicio de Microbiología y Enfermedades Infecciosas
Study Director: Eleonora Bunsow, MD, PhD, Servicio de Microbiología y Enfermedades Infecciosas
Study Chair: 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