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SepsiVit: trends and variability of vital signs in patients with sepsis


- candidate number26148
- NTR NumberNTR6168
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR4-jan-2017
- Secondary IDsMETc 2015/164 201500325
- Public TitleSepsiVit: trends and variability of vital signs in patients with sepsis
- Scientific TitleSepsiVit: trends and variability of vital signs in patients with sepsis
- ACRONYMSepsiVit
- hypothesisTrends in and variability of vital signs reveal hidden information about the state and deterioration of the patient compared to absolute values of vital signs.
- Healt Condition(s) or Problem(s) studiedSepsis
- Inclusion criteria- Age >= 18 years
- Suspected or confirmed infection
- 2 or more SIRS criteria as defined by the 2001 International Sepsis Definition Conference
- Non-trauma patient
- Exclusion criteria- Known pregnancy
- Patient is not admitted in the hospital
- mec approval receivedyes
- multicenter trialno
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeobservational
- planned startdate 16-jan-2017
- planned closingdate31-mrt-2018
- Target number of participants171
- InterventionsNone
- Primary outcomePatient deterioration
- Secondary outcomeInfluence of sepsis focus
- TimepointsFirst 48-hours in the hospital
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIES Vincent M. Quinten
- CONTACT for SCIENTIFIC QUERIES Vincent M. Quinten
- Sponsor/Initiator University Medical Center Groningen (UMCG)
- Funding
(Source(s) of Monetary or Material Support)
University Medical Center Groningen (UMCG)
- Publications
- Brief summaryDespite the adoption of the Surviving Sepsis Campaign (SSC) guidelines, early goal-directed therapy and decades of research, sepsis-related morbidity and mortality remain high. One in five patients with infection or sepsis deteriorates within 48 hours, despite treatment. However, a clear tool to monitor patient deterioration in sepsis remains unclear. Monitoring changes in vital signs over time, so-called variability analysis, may provide information about response to treatment or signs of deterioration. Using continuous variability analysis could be used to determine prognosis and response to treatment of individual patients, i.e. to determine progression towards health or towards deterioration. Previous studies, mainly intensive care unit (ICU) and pilot studies, have shown reduction of heart rate variability (HRV) in critically ill patients and a relation with deterioration. However, the question remains if a reduction of HRV will be found in less ill patients presenting in the ED with infection or sepsis. The primary objective of the SepsiVit study is to find out if continuous HRV measuring during the first 48 hours of hospitalization in patients presenting to the ED with suspected infection or sepsis can provide an early warning signal for patient deterioration. Therefore, vital signs of adult medical patients presenting to the ED with suspected infection or sepsis will be monitored continuously for the first 48 hours of hospitalization with high sample rates using a bedside patient monitor. Variability analysis for HRV will be performed on the data to determine the relation between changes in HRV and patient deterioration.
- Main changes (audit trail)
- RECORD4-jan-2017 - 8-mei-2017


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