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

Sepsis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02325258
• Other study ID #: MICRO.HGUGM.2012-001
• Status: Completed
• Phase: N/A
• First received: December 19, 2014
• Last updated: December 29, 2014
• Start date: August 2012
• Est. completion date: January 2013

Study information

• Verified date: December 2014
• Source: Hospital General Universitario Gregorio Marañon
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Sepsis
• Toxemia

Intervention

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.

Locations

Country	Name	City	State
Spain	Servicio de Microbiologia y Enfermedades Infecciosas	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Emilio Bouza

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sepsis recognition in patients who had blood cultures drawn	Use of diagnostic resources and antimicrobial consumption	72 h	No
Secondary	Health care professionals who correctly identify a case of sepsis		72 h	No