Assessment of a Proposed Microbiological Alert and Its Impact on a Sepsis Campaign
1 other identifier
interventional
300
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable sepsis
Started Aug 2012
Shorter than P25 for not_applicable sepsis
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2013
CompletedFirst Submitted
Initial submission to the registry
December 19, 2014
CompletedFirst Posted
Study publicly available on registry
December 24, 2014
CompletedDecember 30, 2014
December 1, 2014
5 months
December 19, 2014
December 29, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Sepsis recognition in patients who had blood cultures drawn
Use of diagnostic resources and antimicrobial consumption
72 h
Secondary Outcomes (1)
Health care professionals who correctly identify a case of sepsis
72 h
Study Arms (2)
Telephone call
EXPERIMENTALTelephone call to physicians in charge of patients who have just had blood cultures drawn. Diagnostic and therapeutic recommendations to physicians in charge.
No telephone call
NO INTERVENTIONcontrol arm: no intervention
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Emilio Bouzalead
Study Sites (1)
Servicio de Microbiologia y Enfermedades Infecciosas
Madrid, Madrid, 28007, Spain
Related Publications (1)
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.
PMID: 26426609DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- 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
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Head of Department
Study Record Dates
First Submitted
December 19, 2014
First Posted
December 24, 2014
Study Start
August 1, 2012
Primary Completion
January 1, 2013
Study Completion
January 1, 2013
Last Updated
December 30, 2014
Record last verified: 2014-12