Can repeated blood tests for heparin-binding protein concentration predict who will die from sepsis?

ISRCTN	ISRCTN15560762
DOI	https://doi.org/10.1186/ISRCTN15560762

Submission date: 08/10/2020
Registration date: 03/12/2020
Last edited: 12/05/2021

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Infections and Infestations

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

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

Contact information

Dr Jonas Tverring
Scientific

Sölvegatan 19, BMC, B14
Division of Infection Medicine
Department of Clinical Sciences
Lund University
Lund
22184
Sweden

ORCID ID	0000-0003-0939-6673
Phone	+46 (0)737677700
Email	jonas.tverring@med.lu.se

Study information

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
Study setting(s)	Hospital
Study type	Diagnostic
Participant information sheet	Not available in web format, please use contact details to request a participant information sheet
Scientific title	Predicting 90-day survival in septic ICU patients: a post-hoc study of longitudinal heparin-binding protein measures from the FINNAKI cohort
Study objectives	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(s)	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
Health condition(s) or problem(s) studied	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
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 study start date	06/11/2017
Completion date	18/06/2019

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	652 (22%) out of a total 2901 patients included in the FINNAKI cohort
Total final enrolment	652
Key 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
Key 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
Date of first enrolment	01/09/2011
Date of final enrolment	01/02/2012

Locations

Countries of recruitment

Finland

Study participating centre

Helsinki University Central Hospital

HUS Joint Authority
Stenbäckinkatu 9
PO Box 100
Helsinki
00029
Finland

Sponsor information

Lund University
University/education

Division of Infection Medicine
Department of Clinical Sciences
Sölvegatan 19, BMC, B14
Lund
22184
Sweden

Phone	+46 (0)462220000
Email	lu@lu.se
Website	https://www.lunduniversity.lu.se/lucat/group/v1000442
"ROR"	https://ror.org/012a77v79

Funders

Funder type

Government

Swedish Government Research Grant (ALF)

No information available

Stiftelsen Thelma Zoégas fond för medicinsk forskning (91282)
Private sector organisation / Trusts, charities, foundations (both public and private)

Alternative name(s): The Thelma Zoéga Foundation for Medical Research
Location: Sweden

Vetenskapsrådet
Government organisation / National government

Alternative name(s): Swedish Research Council, VR
Location: Sweden

Axis-Shield Diagnostics (UK)

No information available

Results and Publications

Intention to publish date	01/11/2021
Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
Publication and dissemination plan	The researchers intend to publish a manuscript in a peer-reviewed medical journal in 2021.
IPD sharing plan	The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Statistical Analysis Plan		29/10/2020	03/12/2020	No	No

Additional files

ISRCTN15560762_SAP_29Oct2020.pdf: uploaded 03/12/2020

Editorial Notes

12/05/2021: The intention to publish date was changed from 01/05/2021 to 01/11/2021.
03/12/2020: The statistical analysis plan was uploaded as an additional file.
30/10/2020: Trial’s existence confirmed by HUS Ethics Committee