The objective of the study is to improve the detection of sepsis in primary care by developing a clinical decision rule for GPs, consisting of the most relevant clinical features and point-of-care (POC) measurements of biomarkers. This decision rule…
ID
Source
Brief title
Condition
- Infections - pathogen unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome is diagnosis of sepsis within 72 hours of inclusion.
Secondary outcome
Secondary outcomes are severity of sepsis, 30-day mortality, hospital and ICU
admission within 72 hours and length of hospital stay.
Background summary
Diagnosing sepsis in ambulatory primary care is challenging for GPs. The
pre-hospital detection is known to be poor while early detection is important
to prevent adverse outcome. Adaptation of diagnostic strategies from hospital
settings, designed to include all sepsis patients for early treatment and
further work-up, adheres the risk of a substantial increase of unnecessary
referrals. Therefore diagnostic research in the primary care setting is needed
to improve the detection in a cost-efficient manner. With the advent of POCT,
these tests can now also be implemented in ambulatory primary care and even
during home visits.
Our hypothesis is that a structured use of clinical features in combination
with blood tests applicable as POC-tests, can improve recognition and outcome
in sepsis patients.
Study objective
The objective of the study is to improve the detection of sepsis in primary
care by developing a clinical decision rule for GPs, consisting of the most
relevant clinical features and point-of-care (POC) measurements of biomarkers.
This decision rule will help to decrease mortality and morbidity from sepsis as
well as reduce unnecessary referrals.
Study design
Prospective, multicentre, diagnostic and prognostic study.
Study burden and risks
From all patients venous blood samples (22ml total) will be obtained once
directly after inclusion. A single questionnaire is send to all patients 30
days after inclusion. The burden for the included patients is therefore limited
and involves a negligible risk. The target population are largely frail elderly
patients, and some may be incapacitated due to the acute illness. Excluding the
most severely ill patients must be prevented to be able to develop a valid
clinical decision rule. Therefore, the screening procedures for patient
recruitment have been designed to prevent selection bias without compromising
informed consent or medical treatment.
Heidelberglaan 100
Utrecht 3584 CG
NL
Heidelberglaan 100
Utrecht 3584 CG
NL
Listed location countries
Age
Inclusion criteria
1)Adult patients (*18 years)
2)Home visit by a general practitioner from an out-of-hours service
3)Acutely ill patients with fever, confusion or general deterioration or
otherwise suspected of a serious infection.
Exclusion criteria
1) No informed consent
2) Non-infectious cause of the acute complaints, e.g. stroke or myocardial
infarction.
3) Hospitalisation less than 7 days before the home visit.
4) Condition that requires secondary care assessment in case of any signs of
systemic infection (eg chemotherapy with possible neutropenia).
5)Terminal illness or other reason not to refer the patient to a hospital
despite presence of a life-threatening condition.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL63284.041.18 |