Clinical trial NCT02325258: 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
Overall status: COMPLETED
Phase: NA
Conditions: Sepsis
Keywords: Sepsis diagnosis
Sepsis drug therapy
Sepsis outcome
Lead sponsor: Hospital General Universitario Gregorio Marañon
Sponsor class: OTHER
First posted: 2014-12-24
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

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.

Primary outcomes:
measure: Sepsis recognition in patients who had blood cultures drawn
timeFrame: 72 h
Secondary outcomes:
measure: Health care professionals who correctly identify a case of sepsis
timeFrame: 72 h
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Servicio de Microbiologia y Enfermedades Infecciosas
Study officials:
affiliation: Servicio de Microbiología y Enfermedades Infecciosas
name: Emilio Bouza Santiago, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Servicio de Microbiología y Enfermedades Infecciosas
name: Eleonora Bunsow, MD, PhD
role: STUDY_DIRECTOR
affiliation: Servicio de Microbiología y Enfermedades Infecciosas
name: Marcela González Del Vecchio, MD
role: STUDY_CHAIR
affiliation: Servicio de Microbiología y Enfermedades Infecciosas
name: Carlos Sánchez, PharmD
role: STUDY_CHAIR
affiliation: Servicio de Microbiología y Enfermedades Infecciosas
name: Patricia Muñoz García, MD, PhD
role: STUDY_CHAIR
affiliation: Servicio de Microbiología y Enfermedades Infecciosas
name: Almudena Burillo, MD, PhD
role: STUDY_CHAIR
References:
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.