Condition category
Infections and Infestations
Date applied
08/10/2020
Date assigned
03/12/2020
Last edited
03/12/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting
Publication status
Results overdue

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

https://www.lunduniversity.lu.se/lucat/group/v1000442

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

Editorial Notes

03/12/2020: The statistical analysis plan was uploaded as an additional file. 30/10/2020: Trial’s existence confirmed by HUS Ethics Committee