No registrations found.
ID
Source
Brief title
Health condition
Sepsis; community-acquired infections; primary care
Sponsors and support
Material support by Nova Biomedical, ThermoFischer and Philips
Intervention
Outcome measures
Primary outcome
The primary outcome is diagnosis of sepsis within 72 hours of inclusion. The reference standard is an expert panel assessment (following the SEPSIS-3 definitions)
Secondary outcome
Severity of sepsis
30-day mortality
Hospital and ICU admission within 72 hours and length of hospital stay.
Cost-effectiveness
Background summary
The TeSD-IT study is a diagnostic and prognostic study, aiming for the developpement of a simple clinical decision tool for general practitioners. Clinical signs, C-reactive protein, procalcitonin and lactate are used for the development of the model. In total 1000 patients are included during out-of-hours GP home visits. The primary outcome is sepsis within 72 hours of inclusion.
Study objective
A structured use of clincal features in combination with bloodtests applicable as point-of-care(POC) tests, can improve recognition and outcome in sepsis patients
Study design
Follow-up is 30 days.
Intervention
The study is diagnostic and prognostic without an intervention. The following variables are obtained for the development of a clinical decision tool:
Age; temperature; blood pressure; heart rate; respiratory rate; oxygen saturation; rigors; acute clinical deterioration; C-reactive protein; procalcitonin; serum lactate
Feike Loots
Heidelberglaan 100 / P.O. Box 85500
Utrecht 3584 CG
The Netherlands
+31(0)6 24284896
F.J.Loots-2@umcutrecht.nl
Feike Loots
Heidelberglaan 100 / P.O. Box 85500
Utrecht 3584 CG
The Netherlands
+31(0)6 24284896
F.J.Loots-2@umcutrecht.nl
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
IPD sharing statement
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL6848 |
| NTR-old | NTR7026 |
| CCMO | NL63284.041.18 |
| OMON | NL-OMON48847 |