|- candidate number||28560|
|- NTR Number||NTR7026|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||9-feb-2018|
|- Secondary IDs||NL63284.041.18 ZonMw 843001811 |
|- Public Title||Testing for sepsis in primary care|
|- Scientific Title||Testing for sepsis in primary care: diagnostic and prognostic study investigating the potential benefits of point-of-care testing|
|- hypothesis||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 |
|- Healt Condition(s) or Problem(s) studied||Sepsis, Primary care, Community-acquired infections|
|- 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.
|- mec approval received||no|
|- multicenter trial||yes|
|- planned startdate ||1-jun-2018|
|- planned closingdate||1-dec-2019|
|- Target number of participants||1000|
|- Interventions||The 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 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 |
Hospital and ICU admission within 72 hours and length of hospital stay.
|- Timepoints||Follow-up is 30 days. |
|- Trial web site|
|- CONTACT FOR PUBLIC QUERIES|| Feike Loots|
|- CONTACT for SCIENTIFIC QUERIES|| Feike Loots|
|- Sponsor/Initiator ||University Medical Center Utrecht (UMCU)|
(Source(s) of Monetary or Material Support)
|Philips, Thermo Fisher Scientific, ZonMw, grantnumber 843001811, Nova Biomedical|
|- Brief 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. |
|- Main changes (audit trail)|
|- RECORD||9-feb-2018 - 3-mrt-2018|