Plain English Summary
Background and study aims
Sepsis is a leading cause of death and morbidity worldwide. Knowing early in the disease course who is at risk of not surviving could enable better care. With this study, we aim to investigate whether single or repeated measures of a blood test (Heparin-binding protein, HBP) can help prognosticate which patients will die from sepsis.
Who can participate?
Patients who were already included in the FINNAKI study in Finland in 2011-2012.
What does the study involve?
Blood tests and information from electronic health records.
What are the possible benefits and risks of participating?
None.
Where is the study run from?
Patient recruitment in Finland and blood sample and data analysis in Sweden.
When is the study starting and how long is it expected to run for?
Recruitment was done in 2011-2012 and data analysis is planned for 2021.
Who is funding the study?
In Finland: Juselius Foundation, Päivikki and Sakari Sohlberg Foundation, Helsinki University Hospital Grants.
In Sweden: Vetenskapsrådet (Swedish research council) and Swedish research grant (ALF).
Who is the main contact?
Jonas Tverring, jonas.tverring@med.lu.se
Trial website
Contact information
Type
Scientific
Primary contact
Dr Jonas Tverring
ORCID ID
http://orcid.org/0000-0003-0939-6673
Contact details
Sölvegatan 19
BMC
B14
Division of Infection Medicine
Department of Clinical Sciences
Lund University
Lund
22184
Sweden
+46 (0)737677700
jonas.tverring@med.lu.se
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov number
Nil known
Protocol/serial number
Nil known
Study information
Scientific title
Predicting 90-day survival in septic ICU patients: a post-hoc study of longitudinal heparin-binding protein measures from the FINNAKI cohort
Acronym
Study hypothesis
Plasma HBP concentration adds predictive value to clinically available predictors regarding the number of days alive within 90 days from ICU admission (90-day survival) among patients with severe sepsis and septic shock when measured repeatedly during ICU stay (hour 0, 12, 24, 36, 48 hours, 3 days and 5 days from ICU admission, hereafter referred to as “longitudinal HBP” [ng/ml]).
Ethics approval
Approved 17/03/2010, the Ethics Committee of the Department of Surgery, Helsinki and Uusimaa Hospital District (HUS Ethics Committees, PL 705, 00029 HUS Biomedicum Helsinki 2 C 7.krs, Tukholmankatu 8 C, Helsinki, Finland; +358 40 359 4618; eettiset.toimikunnat@hus.fi), ref: 18/13/03/02/2010
Study design
Exploratory post-hoc study of predictive biomarker performance using a cohort from a prospective observational multicentre study
Primary study design
Observational
Secondary study design
Cohort study
Trial setting
Hospitals
Trial type
Diagnostic
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet
Condition
Sepsis and septic shock
Intervention
The researchers will analyze HBP concentration on repeated plasma samples collected from patients in the FINNAKI study at 0, 12, 24, 36, 48, 72 and 120 hours from intensive care unit admission using a commercial HBP ELISA (Axis-Shield Diagnostics, Dundee, UK).
Intervention type
Other
Phase
Drug names
Primary outcome measure
Number of days alive within 90 days from intensive care unit admission measured using patient records
Secondary outcome measures
There are no secondary outcome measures
Overall trial start date
06/11/2017
Overall trial end date
18/06/2019
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Patients included in the FINNAKi study, i.e. all emergency intensive care unit admissions aged >18 years and all elective patients aged >18 years with an intensive care unit stay longer than 24 h
2. Who had severe sepsis or septic shock diagnosed on the day of intensive care unit admission
3. Who had at least one plasma sample available from the first five days of ICU stay
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
652 (22%) out of a total 2901 patients included in the FINNAKI cohort
Total final enrolment
652
Participant exclusion criteria
Exclusion criteria for the FINNAKI study:
1. End-stage renal disease requiring maintenance dialysis
2. Organ donors
3. Received intermediate care
4. Received renal replacement therapy (RRT) while enrolled in the study during a previous ICU admission
5. Transferred from another ICU where the data collection for the study was fulfilled
6. Not permanently living in Finland or unable to give consent due to insufficient language skills
Recruitment start date
01/09/2011
Recruitment end date
01/02/2012
Locations
Countries of recruitment
Finland
Trial participating centre
Helsinki University Central Hospital
HUS Joint Authority
Stenbäckinkatu 9
PO Box 100
Helsinki
00029
Finland
Sponsor information
Organisation
Lund University
Sponsor details
Division of Infection Medicine
Department of Clinical Sciences
Sölvegatan 19
BMC
B14
Lund
22184
Sweden
+46 (0)462220000
lu@lu.se
Sponsor type
University/education
Website
Funders
Funder type
Government
Funder name
Swedish Government Research Grant (ALF)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Stiftelsen Thelma Zoégas fond för medicinsk forskning (91282)
Alternative name(s)
The Thelma Zoéga Foundation for Medical Research
Funding Body Type
private sector organisation
Funding Body Subtype
Trusts, charities, foundations (both public and private)
Location
Sweden
Funder name
Vetenskapsrådet
Alternative name(s)
Swedish Research Council, VR
Funding Body Type
government organisation
Funding Body Subtype
National government
Location
Sweden
Funder name
Axis-Shield Diagnostics (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
The researchers intend to publish a manuscript in a peer-reviewed medical journal in 2021.
IPD sharing statement:
The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request.
Intention to publish date
01/05/2021
Participant level data
Available on request
Basic results (scientific)
Publication list
Publication citations
Additional files
- ISRCTN15560762_SAP_29Oct2020.pdf uploaded 03/12/2020