SepsisNCT02325258
Assessment of a Proposed Microbiological Alert and Its Impact on a Sepsis Campaign
A study testing Telephone call in people with Sepsis, run by Emilio Bouza at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis
- What is being tested?
- Telephone call
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteSpain
- Study dates
- Aug 2012to Jan 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Servicio de Microbiologia y Enfermedades Infecciosas
Madrid, Madrid, 28007
About this study
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.
Read the 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.
- Conditions
- Sepsis
- Being tested
- Telephone call
- Keywords
- Sepsis diagnosis, Sepsis drug therapy, Sepsis outcome
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telephone callOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Telephone call | Experimental | Telephone call to physicians in charge of patients who have just had blood cultures drawn. Diagnostic and therapeutic recommendations to physicians in charge. Receives: Other: Telephone call |
| No telephone call | No intervention | control arm: no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sepsis recognition in patients who had blood cultures drawn
Use of diagnostic resources and antimicrobial consumption
Measured: 72 h
Secondary outcomes (1)
Health care professionals who correctly identify a case of sepsis
Measured: 72 h
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2014 (estimated)
- Study startAug 2012
- Primary completionJan 2013
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SepsisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emilio Bouza
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Emilio Bouza, Hospital General Universitario Gregorio Marañon
- Investigators
- Emilio Bouza Santiago, MD, PhD, Principal investigator, Servicio de Microbiología y Enfermedades InfecciosasEleonora Bunsow, MD, PhD, Study director, Servicio de Microbiología y Enfermedades InfecciosasMarcela González Del Vecchio, MD, Study chair, Servicio de Microbiología y Enfermedades InfecciosasCarlos Sánchez, PharmD, Study chair, Servicio de Microbiología y Enfermedades InfecciosasPatricia Muñoz García, MD, PhD, Study chair, Servicio de Microbiología y Enfermedades InfecciosasAlmudena Burillo, MD, PhD, Study chair, Servicio de Microbiología y Enfermedades Infecciosas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02325258
- Sponsor's protocol ID
- MICRO.HGUGM.2012-001
- Status last verified
- Dec 2014
- First submitted
- 19 Dec 2014
- Last updated
- 30 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 26426609
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of a Proposed Microbiological Alert and Its Impact on a Sepsis Campaign
- ClinicalTrials.gov ID
- NCT02325258
- Acronym / sponsor ID
- MICRO.HGUGM.2012-001
- Conditions
- Sepsis
- Keywords
- Sepsis diagnosis, Sepsis drug therapy, Sepsis outcome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Emilio BouzaUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 24 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Telephone call | Experimental | Other: Telephone callTelephone 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 intervention | –control arm: no intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Telephone callAug-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. | Other | Telephone call |
Primary outcome
Sepsis recognition in patients who had blood cultures drawn
Time frame: 72 h
Use of diagnostic resources and antimicrobial consumption
1 secondary outcome
Health care professionals who correctly identify a case of sepsis
Time frame: 72 h
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2014.
- Derived from this study: PubMed 26426609Bunsow 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emilio Bouza Santiago, MD, PhD principal investigator
Servicio de Microbiología y Enfermedades Infecciosas
Eleonora Bunsow, MD, PhD study director
Servicio de Microbiología y Enfermedades Infecciosas
Marcela González Del Vecchio, MD study chair
Servicio de Microbiología y Enfermedades Infecciosas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telephone call in people with Sepsis, run by Emilio Bouza at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sepsis recognition in patients who had blood cultures drawn (time frame: 72 h). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02325258, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2014.