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Testing for sepsis in primary care


- candidate number28560
- NTR NumberNTR7026
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR9-feb-2018
- Secondary IDsNL63284.041.18 ZonMw 843001811
- Public TitleTesting for sepsis in primary care
- Scientific TitleTesting for sepsis in primary care: diagnostic and prognostic study investigating the potential benefits of point-of-care testing
- ACRONYMTeSD-IT
- hypothesisA structured use of clincal features in combination with bloodtests applicable as point-of-care(POC) tests, can improve recognition and outcome in sepsis patients
- Healt Condition(s) or Problem(s) studiedSepsis, Primary care, Community-acquired infections
- Inclusion criteria1)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 criteria1) 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.
- mec approval receivedno
- multicenter trialyes
- randomisedno
- group[default]
- Type[default]
- Studytypeobservational
- planned startdate 1-jun-2018
- planned closingdate1-dec-2019
- Target number of participants1000
- InterventionsThe study is diagnostic and prognostic without an intervention. The following variables are obtained for the development of a clinical decision tool:
temperature; blood pressure; heart rate; respiratory rate; oxygen saturation; rigors; acute clinical deterioration; C-reactive protein; procalcitonin; serum lactate
- Primary outcomeThe 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 outcomeSeverity of sepsis
30-day mortality
Hospital and ICU admission within 72 hours and length of hospital stay.
Cost-effectiveness
- TimepointsFollow-up is 30 days.
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIES Feike Loots
- CONTACT for SCIENTIFIC QUERIES Feike Loots
- Sponsor/Initiator University Medical Center Utrecht (UMCU)
- Funding
(Source(s) of Monetary or Material Support)
Philips, Thermo Fisher Scientific, ZonMw, grantnumber 843001811, Nova Biomedical
- Publications
- Brief summaryThe 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.
- Main changes (audit trail)
- RECORD9-feb-2018 - 3-mrt-2018


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